AAPS Member Groups Volunteer Handbook. Sections

Transcription

1 2014 AAPS Member Groups Volunteer Handbook Sections

2 Table of Contents AAPS Sections... 6 What is an AAPS Section?...6 Section Descriptions...6 Section Operating Conditions... 9 Section Bylaws Template Duties of Section Officers...23 Student Representatives to Sections...24 Executive Council Liaison Responsibilities to Sections...25 Section and Committee Structure...26 Roles of Committee Members...27 AAPS Committees AAPS Blog Committee (ABC)...28 Annual Meeting Program Committee (AMPC)...28 Annual Meeting Screeners Committee...28 Awards Committee (AC)...29 Content Advisory Committee (CAC)...29 Electronic Program Development Committee (EPDC)...30 Fellows Committee...31 Finance Committee...31 International Affairs Committee (IAC)...31 Member Groups Coordination Committee (MGCC)...32 Membership Strategic Oversight Committee (MSOC)...32 National Biotechnology Conference Program Committee (NBCPC)...33 National Biotechnology Conference Screeners Committee...33 Nominations Committee...34 Program Coordination Committee (PCC)...34 Page 2

3 Publications Committee...35 Student/PostDoc Outreach and Development Committee (SPOD)...36 AAPS Fellows Selection Process...37 Discussion Items for Section Conference Calls Important Dates Section Goals Worksheet Section Webpages AAPS Elections Executive Council...50 Sections...50 Focus Groups...50 Finances Funding for Sections...51 Maintaining Section Treasuries...52 Student Travel...52 Section Quarterly Reports...52 AAPS Focus Groups What is an AAPS Focus Group?...53 Guidelines for the Organization of AAPS Focus Groups...53 Focus Group Officers...54 Focus Group Steering Committees...55 Section & Focus Group Descriptions...56 AAPS Discussion Groups What is an AAPS Discussion Group?...60 Discussion Group Meetings...61 Communication Vehicles Conference Calls...62 Section Connection...63 Page 3

4 Surveys...63 AAPS Newsmagazine...63 Membership Meeting...63 Listserv...64 Social Media...64 AAPS Blog...64 Review of Opinions and Summary Reports Guideline...65 AAPS Resources Leadership Contact Information...68 AAPS Staff...68 AAPS Meeting Planning & Preparation Preparing for the AAPS Annual Meeting & Exposition...69 Jamborees...69 Programming Definitions...70 Programming Submission Site Instructions MIRA System...71 Organizer Guidelines...75 How to Submit a Meeting Idea...76 One Day Facility Hosted Seminars...77 Upcoming AAPS Meetings...77 Sponsorship Solicitation Procedure...77 FDA Sponsorship Policy...77 FDA Speaker Request Form...78 elearning Biotechnology ecourses...81 Webinars...81 Page 4

5 Webinar Guidelines and Tips...82 Volunteer Recruitment & Member Retention Page 5

6 AAPS Sections What is an AAPS Section? AAPS sections are groups of AAPS members with interests in a particular area of pharmaceutical sciences. They have a responsibility for governance and are the primary administrative structures within the association. Sections are broad in scientific scope, have defined operating procedures, a relatively large membership and a fixed financial structure. Sections are represented ex officio on many AAPS committees including the programming committees for the AAPS Annual Meeting and Exposition and the AAPS National Biotechnology Conference. An established section must maintain a membership of at least 200 individuals. Section Descriptions Analysis and Pharmaceutical Quality (APQ) Section The APQ section of AAPS is composed of members whose interests are in the areas of analytical methods development for bulk drug substances as well as drugs in pharmaceutical dosage forms and biological matrices, and methods and procedures for assuring that quality is designed into pharmaceutical products. APQ provides a forum for the exchange of information pertaining to analytical techniques, bioanalytical techniques, regulatory and compendial issues, and assurance of quality. The APQ section interacts with all disciplines involved in the discovery, development, and production of pharmaceutical products, and many of its programs and activities are undertaken with other AAPS sections. Biotechnology (BIOTEC) Section The BIOTEC section is comprised of members from many diverse backgrounds in industry and academia who share a common interest in the evolving field of biotechnology. The primary goal of this section is to unite multiple scientific disciplines in a forum where they can share experimental results as well as concerns regarding the research, development, and commercialization of new biotechnology based pharmaceuticals. Members in this section can meet at national and regional meetings to exchange ideas and present scientific data. Applied and basic scientists, at all phases of research and development for both therapeutic and diagnostic agents, are actively involved in the AAPS BIOTEC section. In particular, the successful discovery, production, delivery, and commercialization of biotechnology derived drugs requires input from many diverse fields including molecular biology, cell culture, recovery process, pharmacokinetics, metabolism, analytical biochemistry, regulatory affairs, and formulation sciences. Clinical Pharmacology and Translational Research (CPTR) Section The CPTR section provides the clinical research dimension within the comprehensive range of pharmaceutical sciences represented in AAPS and is concerned with developing knowledge and understanding related to the clinical use of pharmaceuticals (chemical agents and biological agents). The CPTR section serves as a forum for those scientists engaged in research on the therapeutics and clinical assessment of drugs and biologicals. This section addresses the rational application of pharmaceutical and related sciences in the clinical setting, including experimental design, conduct, and analysis of clinical trials; regulatory aspects of clinical trials and drug registration; risk assessment, therapeutic extrapolation from animals to humans; pharmacoepidemiology; drug interactions; and, in appropriate populations, therapeutic efficacy/safety and the response to alternative dosage forms. The CPTR section provides an opportunity for interaction between scientists in academia, government, and Page 6

7 industry who are engaged in clinical research. The section facilitates the interaction of AAPS members with scientists from other clinical organizations using joint formats such as symposia, workshops, and regional/national meetings. Drug Discovery and Development Interface (DDDI) Section The DDDI section focuses on issues at the critical interface between drug discovery and drug development and provides a collaborative forum for interactions among scientists from academia, industry (large and small pharma), and government institutions. DDDI welcomes participation of all AAPS members (as well as colleagues from other professional organizations) whose efforts are directed toward discovering, optimizing, and effectively transitioning preclinical candidates into the clinical development phase. Formulation Design and Development (FDD) Section The FDD section is comprised of members from many diverse backgrounds in industry, regulatory, and academia who share a common interest in the area of formulation design, research, and development a multidisciplinary field drawing upon the physical, chemical, biological, and engineering sciences. The primary goal of this section is to unite multiple scientific disciplines in a forum where they can share experimental results, consider new formulation and dosage form technologies, and discuss issues and concerns regarding the design and development of formulations/drug products for all dosage forms. This section collaboratively interfaces with other sections which focus on preformulation, biopharmaceutics, formulation strategies, and manufacturing process optimization. Aspects of formulation design and development include the study of dosage forms for drug delivery via all routes of administration wherein the dosage form encompasses the formulation, process by which it is made, and primary packaging. The section s focus on development includes product design, delivery systems and technology, stability, quality, and performance both in vitro and in vivo that is appropriate to its development stage. Manufacturing Science and Engineering (MSE) Section The MSE section brings together all members who are interested in and contribute to the application and advancement of science and technology as it relates to process development and manufacture of pharmaceutical and pharmaceutically related products, including medical devices and active pharmaceutical ingredients. It will provide a forum for exchange of information and networking between members and with members of allied sections and organizations. Areas of specific interest include pharmaceutical product manufacturing (both investigational and commercial), quality assurance, and engineering principles as applied to manufacturing, process optimization, scale-up and technology transfer, and quality systems including manufacturing technical support and quality by design. Physical Pharmacy & Biopharmaceutics (PPB) Section The PPB section is composed of AAPS members whose scientific interests are in the physicochemical and biological factors that impact the design and delivery of small molecules and biologics. PPB is a multidisciplinary section that focuses on preformulation, biopharmaceutics, drug absorption, nanotechnology, and drug delivery systems design and performance including targeted drug delivery. PPB provides an interactive forum for the exchange of information pertaining to the selection of developable drug candidates at the drug discoverydevelopment interface, characterization of drug substance and excipients, studies of relationships between drugs' physicochemical and biopharmaceutical properties and physiological considerations at the cellular, organ, and whole animal levels, and overcoming drug absorption and delivery barriers via drug delivery technologies. Page 7

8 Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Section The PPDM section provides an international forum to examine issues related to the biopharmaceutics, pharmacokinetics, pharmacodynamics, drug metabolism, and transport of pharmaceuticals and biologicals. PPDM brings together individuals whose research interests include characterization of drug/drug products, drug disposition, and biotransformation at the organism, tissue, cellular, and subcellular levels. The section provides an opportunity for networking, presentation of new data, and exchange of ideas by individuals actively engaged in various facets of pharmacokinetics, pharmacodynamics, drug metabolism, and transport; biopharmaceutics; and related sciences. This scientific exchange enables scientists from academia, industry, and regulatory agencies to improve/develop better therapies while jointly advancing their professional development and respective disciplines. PPDM recognizes the need for education and training of new scientists through active recruitment of new students and postdoctoral fellows, support of graduate faculty, and encouraging student participation in all PPDM activities. Regulatory Sciences (RS) Section The Regulatory Sciences (RS) section focuses on providing its members with the tools, programming, and networking opportunities needed to help them grow in areas such as regulatory compliance, GMP, clinical and pre-clinical practices; the legal aspects of pharmaceutical development; and protection of intellectual property. Our membership is composed primarily of professionals who practice regulatory affairs in the pharmaceutical and biopharmaceutical industries, academia, and health authorities. We collaborate with other AAPS sections, sister organizations, and regulators to inform pharmaceutical scientists of the global regulatory landscape and help shape global regulatory strategies. RS section members are involved with all aspects of drug development from discovery through life cycle management and place a special emphasis of continuous learning and training in accomplishing their objectives. Page 8

9 Section Operating Conditions The operating conditions must be signed at the beginning of the section chair s term in November and forwarded to Maria Nadeau, Member Groups Manager, AAPS via at NadeauM@aaps.org or by fax at (703) Criteria for Section Review The following criteria for section review were approved by the EC and are included in the enclosed operating conditions, which you are asked to sign. All AAPS Sections must meet the following criteria: 1. Mission Statement Each section must have a mission statement that is unique and defines useful and needed service to its membership. The section mission must fit with the AAPS mission. 2. Record Keeping Sections must provide all of the following information to AAPS: information on awards and nominations (including Fellows nominations); yearly Summary of Activities (due at the annual meeting); yearly financial report (due at the annual meeting); any other requests for information, (e.g., science policy issues); and a schedule of upcoming meetings, conferences, and seminars, as well as copies of newsletters, minutes, press releases, and other materials describing section activities. Each section is expected to perform/meet the following activities/obligations. 1. Programming/Educational Each section is expected to perform the following minimum programming/educational activities each year. At least one programming event at the annual meeting At least one other programming/educational event which will take the form of another AAPS meeting (including: workshops, mid-year meetings, PT Conference type meeting) 2. Focus Group Affiliations Each section is expected to have at least two primary affiliated focus groups. 3. Member Outreach Activities Sections must perform at least one membership outreach activity each year. Outreach activities include, but are not limited to: Journal development Initiating, fostering and maintaining Focus Groups Mentoring students Interaction with local discussion groups, Student recruitment efforts Membership recruitment efforts Professional development activities for members Page 9

10 AMERICAN ASSOCIATION OF PHARMACEUTICAL SCIENTISTS OPERATING CONDITIONS OF THE SECTION These Operating Conditions are effective the day of, 20 (the Effective Date ) and agreed to by the American Association of Pharmaceutical Scientists ( AAPS ), a District of Columbia nonprofit corporation, and the Section, a component of AAPS. 1. NATURE OF RELATIONSHIP 1.1 Section. The Section is a component and part of the AAPS corporate entity which functions to further the tax-exempt purposes of AAPS. The Section has been granted limited autonomy solely for such tax-exempt purposes and is subject to these Operating Conditions (including Attachments), the mission and requirements of the AAPS Articles of Incorporation and Bylaws, and the policies and procedures adopted by the AAPS Executive Council. The Section is subject to the same legal restrictions as AAPS with regard to permissible purposes and activities, lobbying activities, a prohibition against engaging in any political activity, and other matters as outlined in the guidelines established by AAPS. The Section shall adopt specific program goals, objectives, and unique procedures for its internal operations (set forth in Attachment A), which must be consistent with AAPS guidelines, approved by the AAPS Executive Council, and maintained as current at all times in the AAPS materials and files (including on the Extranet) by the Section leadership. 1.2 Intellectual Property. The Section acknowledges that all AAPS names, logos (including section logos), copyrights, trademarks, books, records, publications, mailing lists, membership lists, and related material are the sole property of AAPS, and all use of such intellectual property by the Section shall be subject to approval by AAPS and to guidelines established by AAPS. All right, title, and interest, including but not limited to copyrights and all rights subsumed there under, in and to materials or property that may be prepared or developed by the Section or its volunteers pursuant to these Operating Conditions are owned by and assigned to AAPS; provided, however, that the Section may copy, revise, distribute, modify, and otherwise use materials created by the Section for Section purposes, in accordance with accepted AAPS policies and procedures Confidential Property. The Section acknowledges that it may be exposed to certain information, materials, and property related to AAPS that may be considered confidential or proprietary, including but not limited to financial information, trade secrets, written material, membership lists, and mailing lists. The Section and its officers agree not to use or disclose, or to cause to be used or disclosed, at any time during or after the effective term of these Operating Conditions, any confidential or proprietary information, materials, or property of the other, except as may be specifically authorized by AAPS. This material will be marked as such Financial Support. AAPS provides funds to support the Section s programming and organizational functions in accordance with the approved annual budget. The Section may request additional funding from the AAPS office through their staff liaison. Upon submission, requests may be approved or denied by the AAPS Executive Council. The Section will annually report all financial information to AAPS pursuant to the terms of Section MEMBERSHIP All members of the Section must be members of AAPS. Page 10

11 3. OBLIGATIONS OF AAPS The AAPS staff in Arlington, Virginia shall to the extent practical assist the Section in administering and planning its activities, helping with mailings, sending relevant publications to Section officers, and providing other assistance as agreed. 4. OBLIGATIONS OF THE SECTION The Section s obligations include the following: 4.1 Record Keeping and Reporting. The Section shall maintain financial records as required by the guidelines adopted by the AAPS Executive Council and shall submit to AAPS on an annual basis a financial report as well as a summary of activities the Section has undertaken during the year. This summary of activities should include information on awards and nominations (including Fellows), as well as a schedule of upcoming meetings, conferences, and seminars, as well as copies of newsletters, minutes, press releases, and other materials describing Section activities. All such activities and publications, including any uses of the AAPS name, logo, or copyrights, are subject to prior review and approval in accordance with accepted AAPS policies and procedures. The financial and activity reports are due at the annual meeting. It is understood that these financial record keeping and reporting obligations are mandated by applicable tax laws and regulations of the Internal Revenue Service and must be complied with by the Section without fail. 4.2 Activities and Affiliations. The Section shall organize at least one educational and one professional programming event each year. The Section shall use its best efforts to ensure that such programs are of the highest quality with respect to program content, materials, and logistical preparation. Each Section is expected to have at least two primary affiliated Focus Groups. In addition, Sections are expected to perform at least one membership outreach activity each year. Outreach activities include, but are not limited to journal development, initiating, fostering and maintaining Focus Groups, and mentoring students. 4.3 Contractual Authority. The Section must adhere to the policies and procedures adopted by the AAPS Executive Council in connection with the engagement of consultants. All engagements and/or contractual arrangements, including but not limited to contracts to engage consultants or to hold or reserve facility or hotel space, must be directed through the staff liaison to AAPS for advance written approval of the AAPS Executive Council. AAPS is not responsible for the acts or omissions of any parties engaged by the Section or for the contractual obligations of the Section. The representatives of AAPS and the Section agree to these Operating Conditions, which are reconfirmed annually by the Chair of the Section. Executive Director, AAPS Chair, Section President, AAPS Date Date Date Page 11

12 Attachment A Procedure Guide of the Section (Attach existing procedure guide of individual Section) Page 12

13 Section Bylaws Template AAPS created a general template for section-specific by-laws. Use this document to create or amend the bylaws for your section. All section bylaw changes must be consistent with the AAPS Bylaws and approved by the Executive Council (EC). Whenever the section officers recommend a change in the by-laws, approval should be sought first from the EC and then from the membership. Membership approval may be obtained via vote, or at the next membership meeting during the AAPS Annual Meeting and Exposition. To implement a change in the by-laws, it must be approved by more than two-thirds of the members responding to the ballot, or present at the business meeting. LawsTemplate.pdf Page 13

14 Recommended Bylaws Last revised 1/27/08 Recommended Bylaws Last revised 1/27/08 GENeric Section of the American Association of Pharmaceutical Scientists ARTICLE I: Name This section shall be named the Generic section of the American Association of Pharmaceutical Scientists. Abbreviated, it is the GEN section of AAPS. ARTICLE II: Objective [Specific to each section. Should be aligned with the vision, mission, and values of the AAPS (see below).] AAPS VISION The American Association of Pharmaceutical Scientists will be the premier organization of all scientists dedicated to the discovery, development and manufacture of pharmaceutical products and therapies through advances in science and technology. AAPS MISSION The American Association of Pharmaceutical Scientists provides a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to health. We offer timely scientific programs, ongoing education, opportunities for networking and professional development. AAPS VALUES Communication AAPS is committed to effective communication throughout the Association, with other organizations and with the public. Inclusiveness AAPS values diversity in its membership and scientific disciplines and promotes inclusiveness. Innovation AAPS is committed to innovation in science and technology. Integrity AAPS is committed to the highest standards of ethical conduct. Member Focus AAPS is an organization driven by the needs of its members. Member Involvement - AAPS supports and encourages the active participation of all its members. Professional Development AAPS values professional development through networking, mentoring, education and scientific exchange. Quality AAPS is committed to promoting quality science and offering quality programming, publications, and other services to its members, the scientific community and the public. Page 14

15 ARTICLE III: Membership Any member in good standing of AAPS whose scientific interests are related to the area of Generics shall be eligible for membership in the GEN section. Individuals may apply for GEN membership through the AAPS national office. Information about the section can be obtained by contacting the GEN officers or a member of the GEN Membership Committee. If the interests of the member change, they can change their section affiliation anytime. A GEN member may be a member of multiple sections. All members in good standing in GEN shall be eligible to vote. ARTICLE IV: Officers and Succession [These are Section specific. Two examples are provided] Section 1. Officers. The officers of GEN shall consist of five individuals: chair, chair-elect, vice chair, secretary/treasurer and immediate past chair. These officers shall constitute the GEN section Executive Committee (EC). Section 2. Succession. The order of succession is as follows: chair becomes past chair, chair-elect becomes chair, and vice chair becomes chair-elect. If a vacancy in an office should occur, the executive committee of GEN may appoint a replacement. Alternatively, the order of succession is as follows: chair becomes past chair, chair-elect becomes chair, vice chair becomes chair-elect, and secretary/treasurer becomes vice chair. If a vacancy in an office should occur, the executive committee of GEN may appoint a replacement. Section 3. Removal. The AAPS Executive Council may be a two-thirds vote of its members remove any GEN officer from office who is guilty of neglect of duty, improper conduct, a violation of these bylaws, or other causes. Prior to voting on a removal the Executive Council shall provide the officer with written notice of the reasons for the removal and an opportunity to appear before the Executive Council for a due and proper hearing. ARTICLE V: Terms of Office The term of office shall be one year for all offices, except for the secretary/treasurer which shall be two or three years. [Section specific depending on succession] ARTICLE VI: Duties of Officers [Combined duties from multiple sections] Section 1. Chair Leads the GEN section. Holds regular meetings of the GEN Executive Committee. Presides at the GEN EC and business meetings and prepares agenda for such meetings. Leads strategic discussion and develops planning which may occur at an annual offsite face-to-face meeting. Represents GEN as appropriate outside of the GEN section, including the AAPS Executive Council. Page 15

16 Serve as GEN section representative to AAPS Nominations Committee (i.e., AAPS President-Elect and Members-at-Large). Relays and receives communications to the AAPS Executive Council directly or through the assigned Member-at-Large. Sits on the GEN Nominations Committee. Provides direction to GEN committees. Appoints members and chairs of existing GEN committees and AAPS committees. Creates new GEN committees and provides direction as needed. Communicates bylaws and job function to nominees for all section offices. Attends the AAPS leadership retreats as invited. Section 2. Chair-elect Chairs the GEN Program Committee and serves as the GEN section representative on the Annual Meeting Programming Committee (AMPC). Coordinates GEN programming for the year. Generally serves as GEN section representative on the AAPS Program Coordinating Committee (PCC). [The section may appoint either the chair, the past chair, or the chairelect as the section representative to the AAPS Program Coordination Committee. Approved by AAPS EC 10/04.] Serves as liaison for AAPS Focus Groups. Develops agenda for tenure as chair, consistent with AAPS goals and objectives. Acts as chair in the absence of the chair. Section 3. Vice Chair Acts as chair in the absence of both chair and chair-elect. Develops an understanding of GEN section and AAPS operations and bylaws. Serves as the GEN programming co-chair along with the chair-elect. Serves on the GEN Program Committee for the current year's annual meeting, and chairs the GEN Program Committee for next year's annual meeting. Coordinates offsite GEN face-to-face meetings. Section 4. Secretary/Treasurer Records the minutes of all GEN meetings and distributes as directed. Corresponds with GEN membership as directed by the chair. Coordinates correspondence of the GEN Executive Committee as directed. Provides copies of pertinent GEN correspondence and records to AAPS GEN staff liaison. Prepares information as necessary for inclusion in the AAPS Newsmagazine. Maintains and reviews financial records of section through the AAPS GEN staff liaison. Serves as acting chair of GEN Finance Committee. Archives all GEN records (e.g., minutes, memos, brochures, and financials). Responsible for the content of the GEN section of the AAPS website (some sections may want a different person responsible for this). Section 5. Past Chair Acts as advisor to the section officers. Serves as chair of the GEN section Nomination Committee). Serves as chair of the GEN section Awards Committee. Page 16

17 ARTICLE VII: Executive Committee [If not different than the officers listed in Article IV then this section could be omitted] These GEN section officers, appointed committee chairs, and a student member (described below) shall compose the GEN Executive Committee. ARTICLE VIII: Appointed Section Liaisons Section 1. Executive Council Member-at-Large Represents the GEN section on the AAPS Executive Council. Will be the GEN section spokesperson on all AAPS Executive Council conference calls/meetings. Will be invited to participate on all GEN section conference calls and meetings. Will inform the GEN section of any necessary AAPS Executive Council procedures, policies and/or changes. Section 2. Staff Liaison Will be invited to participate on all GEN section conference calls and meetings. Represents the GEN section on AAPS Executive Council conference calls/meetings if the AAPS Executive Council Member-at-Large is unable to participate on the call or meeting. Assists the AAPS Executive Council Member-at-Large in informing the section of any changes, new policies or procedures made by the AAPS Executive Council. Section 3. Member Groups Manager Will be the point of contact for the GEN section for all staff-related questions. Assists the GEN section secretary/treasurer in maintaining the section s financial records. Manages the activities of the GEN section. ARTICLE IX: Section Committees [Section specific, examples provided. Not all sections have all of these committees. Some sections have combined multiple committees into one.] The standing committees and their duties are described below. Those underlined are considered mandatory AAPS committees. The GEN chair will select the committee representatives which are then approved by the GEN Executive Committee. An effort should be made each year to replace some of the committee members. Committee representatives should be members of the GEN section. The term as committee representatives shall be three (3) years unless otherwise noted. Term of committee representative is assumed immediately following the AAPS Annual Meeting and Exposition unless otherwise noted. In order to ensure appropriate training and continuity, each committee should make attempts to have both a chair and chair-elect. The following are two succession plan examples which provide for a three year term as committee chair. Example 1: Year 1: Representative and past representative work together Year 2: Representative Year 3: Representative trains the incoming representative Example 2: Year 1-2: Representative Year 3: Representative trains incoming representative Page 17

18 Section 1: AAPS Blog Committee (ABC) The ABC develops topical and timely content for the AAPS Blog. The ABC members should have broad knowledge of and interest in current issues affecting pharmaceutical scientists and extensive experience using social media platforms. Prior blog experience is preferred. The GEN representative shall be appointed by the GEN section chair-elect and serve for a renewable term of one year. Section 2: AAPS Annual Meeting Program Committee (AMPC) The AMPC selects the theme of the plenary session, as well as the content, programming format, and the time schedule for programming activities of the AAPS Annual Meeting and Exposition. The committee also selects the keynote and plenary session speakers. The GEN section chair-elect is a member of the committee. Section 3: AAPS Annual Meeting Screeners Committee (AMSC) The AMSC reviews all contributed papers submitted for presentation at the AAPS Annual Meeting and Exposition. The committee will evaluate the contributed papers based on criteria published in the call for papers. The GEN representative shall be appointed by the GEN section chair-elect and serve for a three year term. Section 4: AAPS Awards Committee (AC) The AC provides recommendations regarding structure and procedures for section awards, nonsection awards, and travelships. This includes but not limited to reviewing awards for potential overlap; recommendation to discontinue awards, if needed; recommendations regarding strategies to increase award applicants; streamlining the award application process; and recommendations on how best to fund awards, monetary guidelines and ranges and provide resources and guidelines for sponsor funds. All committee members should be comfortable with fundraising activities. The GEN representative shall be appointed by the GEN section chair-elect and serve for a three year term. Section 5: AAPS Content Advisory Committee (CAC) The CAC is responsible for soliciting and securing topical and timely content (e.g., feature articles, news briefs) for the AAPS Newsmagazine. It is the aim of the committee to help bolster the stature of AAPS Newsmagazine, both to readers and advertisers. The GEN representative shall be appointed by the GEN section chair-elect and serve for a three year term. Section 6: AAPS Electronic Program Development Committee (EPDC) The EPDC solicits and selects the theme (e.g. BT 101) as well as the individual lecture content, programming format, appropriate presenters/reviewers and evaluation criteria for on-demand, web-based AAPS elearning Courses. The GEN representative shall be appointed by the GEN section chair-elect and serve for a three year term. Section 7: AAPS Fellows Committee The Fellows Committee seeks out nominees for Fellow status and ensures that GEN section candidates are properly presented to the AAPS Fellows Committee. An AP GEN section Fellow represents the GEN section on the AAPS Fellows Committee and chairs the GEN Section Fellows Committee. The GEN representative shall be appointed by the GEN section chair-elect and serve for a three year term. Section 8: AAPS Membership Strategic Oversight Committee (MSOC) Page 18

19 MSOC analyzes AAPS demographic parameters, member groups, services, and benefits in order to make recommended improvements. The committee also facilitates a member satisfaction survey that is implemented every three to five years. The GEN representative shall be appointed by the GEN section chair-elect and serve for a three year term. Section 9: AAPS National Biotechnology Conference Program Committee (NBCPC) The NBCPC selects the content, programming format, and the time schedule for programming activities of the AAPS National Biotechnology Conference. The committee also selects the keynote and plenary session speakers. The term of this committee changes each year immediately following the AAPS National Biotechnology Conference. The GEN representative shall be appointed by the GEN section chair-elect and serve for a three year term. Section 10: AAPS National Biotechnology Conference Screeners Committee (NBCSC) The NBCSC reviews all contributed papers submitted for presentation at the AAPS National Biotechnology Conference. The committee will evaluate the contributed papers based on criteria published in the call for papers. The term of this committee changes each year immediately following the AAPS National Biotechnology Conference. The GEN representative shall be appointed by the GEN section chair-elect and serve for a three year term. Section 11: AAPS Nominations Committee The Nominations Committee seeks, identifies, and nominates the best candidates for the AAPS national offices, including the AAPS Executive Council president, treasurer, and members-atlarge. It is the responsibility of the committee to conduct a fair and balanced review and selection from all of the nominations put forward by AAPS members and to ensure there are appropriate and qualified to serve the association. The GEN section chair is a member of the committee. Section 12: AAPS Program Coordination Committee (PCC) The PCC evaluates and makes recommendations to the Executive Council on meeting proposals other than the AAPS Annual Meeting and Exposition and AAPS National Biotechnology Conference. The PCC is charged with clustering as many proposals as possible. The GEN section [chair, chair-elect, or past chair] is a member of the committee. Section 13: AAPS Publications Committee The Publications Committee makes recommendations on possible avenues for improvement relating to all AAPS publications including AAPS scientific journals, AAPS website, AAPS Newsmagazine, and books program. The GEN representative shall be appointed by the GEN section chair-elect and serve for a three year term. Section 14: AAPS Student/PostDoc Outreach and Development (SPOD) Committee The SPOD Committee addresses issues of concern to graduate students, undergraduate students, and postdoctoral fellows, which includes fostering programs, interactions, and activities in the pharmaceutical and related sciences. The GEN representative shall be appointed by the GEN section chair-elect and serve for a three year term. Section 15: GEN Awards Committee The GEN Awards Committee is responsible for seeking out nominees and for selecting recipients of GEN Section awards. The committee chair shall be appointed by the GEN section chair-elect for a renewable term of one year. Page 19

20 [Awards should be listed. As examples: Research Achievement Award, Graduate Student Award, Young Investigator Award.] Section 17: GEN Focus Group Liaison The charge of the Focus Group Liaison is to improve operations of the section s primary focus groups by educating the focus group chairs and sharing best practices between the focus groups. The liaison will receive all correspondence from the section s primary focus groups, and be invited to the monthly focus group and section calls. The Focus Group Liaison will improve communication between the section and focus groups, monitor activities, and increase collaborations between the section and focus groups. The liaison will provide recommendations about the focus group operations to the section officers. If a focus group is not functioning, then the liaison will work with the section officers to improve operations or determine if the focus group is no longer needed. The Focus Group Liaison shall be appointed by the GEN section chairelect for a recommended three year term. Section 10. Graduate Student Representative [or Committee] There shall be a Graduate Student Representative who is a graduate student member of the GEN section. This person shall be appointed by the GEN section chair-elect and shall serve for a renewable term of one year. This student may appoint additional committee members for at maximum the duration of his/her term. The function of this student is to represent the needs of GEN section graduate student members to the GEN section and to enhance graduate student input on many of the current GEN committees. Specific responsibilities include but are not limited to generation of graduate student related programming and implementation of the mentoring program. The student will participate in monthly GEN section teleconferences. Section 1. GEN Membership Committee The function of this committee shall be to recruit and maintain membership in the GEN Section. The committee chair will also be responsible for disseminating information about the section and its activities as well as other scientific or practical information useful to the members. Section 2. GEN Nominations Committee The GEN Nominations Committee nominates members of the GEN Section as candidates for section office. The committee is headed by the section past chair and shall consist of the GEN Section Executive Committee and additional members selected by the committee, as needed. The GEN Nominations Committee is responsible for providing nominations for vice chair [or secretary/treasurer] annually and for secretary/treasurer every two or three years. [section specific] At least two candidates should be nominated for each office. The function of this committee shall be to identify criteria for selecting nominees and based on these criteria, to provide a slate of nominees for the annual section election. Section 5. GEN Program Committee The GEN Program Committee shall be composed of at least five [section specific] members that will be responsible for yearly programming. The function of this committee shall be to organize and arrange all programming aspects of the GEN section s contribution to the AAPS Annual Meeting and Exposition, the AAPS National Biotechnology Conference and to coordinate all activities for ancillary programming (workshops, short courses, open forums). This committee will interface with existing AAPS focus group chairs to solicit programming input. The chair of the Program Committee will be the GEN chair-elect who will serve as the section s representative to the AAPS Annual Meeting Planning Committee (AMPC). The GEN vice chair Page 20

21 shall be the Programming Committee co-chair. The co-chair will be responsible for organizing the program plans for the subsequent annual meeting. Therefore, GEN programming represents a two year commitment, initiated when an individual is elected as vice chair and following through until the annual meeting the following year as chair-elect. Section 19: GEN Open Forum Committee The GEN Open Forum Committee is responsible for soliciting topics for the open forum, selecting an appropriate topic (in conjunction with the GEN EC), and working with the moderators, organizers, and AAPS staff to ensure that logistics and marketing are properly managed. Section 11. AAPS and Ad Hoc Committees The GEN chair, in consultation with the GEN Executive Committee, will appoint GEN representatives to standing and ad hoc AAPS committees and task forces, as requested by the AAPS Executive Council. [Ad hoc committees and task forces should be listed.] ARTICLE X: Nominations and Elections [Section specific, examples provided. The four sections listed below, however, should be included.] Section 1. Eligibility Members who have selected GEN as their section within AAPS are eligible for election as officers to the GEN section or appointment to the GEN Executive Committee. All members of GEN shall be eligible for appointment to standing committees or special committees of GEN. No person who has served as section chair is eligible for nomination as vice chair for five (5) [section specific] years after serving as chair of the section. Section 2. Solicitation of Nominations Nominations shall be selected from the GEN section membership by nomination from the floor at the annual meeting and/or through correspondence with the membership. From these nominations, the GEN Nominations Committee should select at least two (2) nominations for each elective office. Nominations for vice chair are provided annually. Nominations for secretary/treasurer are provided every two or three years [section specific]. All nominations are subject to approval by the GEN Executive Committee. Section 3. Elections All procedures for election of new officers shall be the same as those for AAPS Executive Council elections as defined by the AAPS Bylaws. The winner will be determined by simple majority of the votes cast in the election. Section 4. Term of Service The term of office shall be one (1) year for all offices, except for the secretary/treasurer which shall be two (2) or three (3) years. [Section specific depending on succession] ARTICLE XI: Membership Meeting The GEN section will have an annual membership meeting in conjunction with the AAPS Annual Meeting and Exposition. The agenda for this meeting is the decision of the GEN chair, who presides at the meeting. The purpose of the meeting is to inform the GEN membership about section activities and provide the opportunity for solicitation of nominations for section officers. The meeting will include a report from selected GEN section committees. The intent of the meeting is to provide a forum where GEN membership may raise issues and concerns pertaining to the GEN section. Page 21

22 Article XII: Amendments The GEN section Bylaws should be reviewed annually. GEN section officers or section members may propose amendments to the GEN section Bylaws. Proposals must be made in writing and submitted to the section chair. GEN section officers can modify the GEN Bylaws as needed during the year. An affirmative vote by a two-thirds majority of the section officers is necessary for approval of changes to the bylaws. However, the proposed changes, if deemed to be significant, should be brought to the attention of the GEN membership. Approval must be sought from the membership at the next meeting of the section held in conjunction with the AAPS Annual Meeting and Exposition or through a vote by an accepted media (mail, , fax, or website). Approval will be made based on a simple majority of the votes returned. Page 22

23 Duties of Section Officers Terms of Office The vice chair shall be elected annually and shall automatically become chair-elect at the end of the term as vice chair. The chair-elect shall become chair after serving one year in this office. The chair s term of office is one year, after which they become immediate past chair for one year. For most sections, the secretary/treasurer shall be elected in alternate years, and shall serve two years in this office. Tenure of office is assumed immediately following the AAPS Annual Meeting and Exposition. If the office of chair, vice chair, or secretary/treasurer becomes vacant, refer to your section s by-laws for specific procedures. Chair Leads the section. Holds regular meetings of the Section Executive Committee. Coordinates off-site section face-to-face meetings. Presides at the Section EC and business meetings and prepares agenda for such meetings. Leads strategic discussion and develops planning which may occur at an annual off-site face-toface meeting. Represents section as appropriate outside of the section. Serve as section representative to AAPS Nominations Committee. Relays and receives communications to the AAPS Executive Council directly or through the assigned Member-at-Large. Sits on the section Nominations Committee. Provides direction to section committees. Approves the section budget for the following fiscal year. Creates new section committees and provides direction as needed. Communicates by-laws and job function to nominees for all section offices. Attends the AAPS leadership retreats as invited. Chair-elect Chairs the Program Committee and serves as the section representative on the Annual Meeting Programming Committee (AMPC). Coordinates section programming for the year. Serves as liaison for focus groups. Appoints members and chairs to section committees and AAPS committees. Develops agenda for tenure as chair. Acts as chair in the absence of the chair. Vice Chair Acts as chair in the absence of both chair and chair-elect. Develops an understanding of section and AAPS operations and by-laws. Serves as the section programming co-chair along with the chair-elect. Serves on the Section Program Committee for the current year s annual meeting, and chairs the Section Program Committee for next year s annual meeting. Page 23

24 Secretary/Treasurer Records the minutes of all section meetings and distributes as directed. Corresponds with section membership as directed by the chair. Coordinates correspondence of the Section Executive Committee as directed. Provides copies of pertinent section correspondence and records to AAPS staff liaison. Prepares information as necessary for inclusion in the AAPS Newsmagazine. Maintains and reviews section financial records through the AAPS section staff liaison. Serves as acting chair of Section Finance Committee (if applicable). Archives all section records (e.g., minutes, memos, brochures, and financials) through the AAPS section staff liaison. Responsible for the content on the section website (some sections may want a different person responsible for this). Past Chair Acts as advisor to the section officers. May serves as chair of section committees. Student Representatives to Sections The Executive Council feels strongly that the best way to impact the quality of student programming, build future leaders, and involve students in all aspects of AAPS is to encourage their participation at the section level. All AAPS sections must appoint students to their respective Executive Committees. Page 24

25 Executive Council Liaison Responsibilities to Sections Each Member-at-Large is assigned as a liaison to an AAPS Section(s). The MAL will work with the section for one year. A new MAL may be assigned after the AAPS elections. Recognizing that the Executive Council (EC) Members-at-Large (MAL) should be the conduit between the EC and the Sections, and that the MAL represents the interests of the section membership on the EC, it is recommended that: At the beginning of the year, the MAL is assigned to represent a section or sections. It is important for reasons of impartiality that the MAL not be a primary member of the section to which he/she is assigned. The MAL should participate in conference calls and section meetings. The AAPS staff will produce the AAPS Section Connection, a mechanism to allow: o the MAL to provide the EC with summaries of issues of substance from the sections o the MAL to provide a written summary of the monthly EC meetings in order to add any relevant interpretations and then forward to their assigned section(s) The MAL will be responsible for assuring that responsibilities assigned to the sections by the EC are transmitted to the section and its leadership. This is particularly important in light of section leadership changing from year-to-year. The annual leadership orientation should orient the MALs to their responsibilities to the section as well as to the EC. During the annual leadership orientation, both the section leadership and the MALs should be clearly informed as to their mutual responsibilities and interaction. If the section leadership has a basis for believing that the MAL is not representing the interests of the section on the EC, the section chair should first approach the MAL for resolution. If, in the opinion of the section leadership, this first step has not resolved the issues, the section chair can approach the Executive Director of AAPS to initiate resolution. If a section is not performing activities that are in the membership s best interests, the MAL may recommend that the section chair (or other section leaders) attend an Executive Council meeting for an explanation. Ultimately, failure to serve the membership can result in probation. Once a section is placed on probation, a list of goals and objectives will be given to the section with a completion deadline. Page 25

26 Section and Committee Structure The chair-elect of each section is asked to select section representatives for each committee. The committee representatives term begins when the chair-elect takes office as chair (during the annual meeting). AAPS will send the chair-elect an at the end of May requesting committee representatives for the following year. The will clarify the length of service for each committee and outline when a new committee member must be appointed. Attached are guidelines for AAPS section and committee structure. Guidelines for AAPS and Section Committee Structure The following are guidelines to assure a vigorous committee structure for AAPS and full participation by the entire membership. 1. Regular rotation of committee chairs. Chairs should ordinarily be rotated at least every three years. This will help ensure a constant flow of new ideas and leadership. 2. Annual appointment of new members. At least a third of the committee membership should be new each year. Ordinarily, these should be selected from a list of volunteers for committee assignments solicited from the membership. 3. Where possible, committee chairs should be strongly encouraged to select at least half of their new members from a list of AAPS member volunteers who have not previously served on AAPS committees. 4. Discourage member from serving on multiple committees. This will simultaneously assure broader participation and relieve any individual members of the burden of excessive responsibilities. 5. Activities of all AAPS committees should be reported periodically as requested by the Executive Council. 6. Committees, which have been inactive for a year, should be discontinued unless there are some compelling extenuating circumstances. 7. As opposed to standing committees with defined charters, AAPS should readily form ad hoc committees to accomplish specific tasks that will minimize bureaucracy and encourage more rapid turnover of committee membership and the involvement of new members. Page 26

27 Roles of Committee Members Each year in May, the chair-elect in each section will receive an from AAPS outlining each committee, current representatives, and term limits. The chair-elect will appoint representatives for the following year and submit the information to AAPS by August. Current AAPS committees include: AAPS Blob Committee (ABC) Annual Meeting Program Committee (AMPC) [this is always the chair-elect] Annual Meeting Screeners Committee Content Advisory Committee Electronic Program Development Committee (EPDC) Fellows Committee [this person must be an AAPS Fellow] Finance Committee International Affairs Committee Member Groups Coordination Committee (MGCC) Member Strategic Oversight Committee (MSOC) National Biotechnology Conference Committee National Biotechnology Conference Screeners Committee Nominations Committee [this is always the section chair] Program Coordination Committee (PCC) [this is the chair, chair-elect, or past chair] Publications Committee Student/PostDoc Outreach and Development (SPOD) Committee Section Committee Representatives on AAPS Committees The list above outlines which committees require representatives by virtue of office (i.e., AMPC, PCC, etc ). The section chair also appoints section representatives on AAPS committees where the section representative is not specified by virtue of office. Such AAPS committees include the Content Advisory Committee, Student/PostDoc Outreach and Development (SPOD) Committee, National Biotechnology Conference Committee, Webmaster Committee, and the Membership Strategic Oversight Committee. One person is to be nominated from each section for a three year term limit. Special Ad Hoc Committees The section chair shall appoint additional ad hoc committees as needed to facilitate the activities of the section. The duties of each committee shall be prescribed by the chair in writing. Examples of such ad hoc committees include the Awards Committee, Publications Committee, Workshop Committee, etc. The number of people on each committee and term limit is determined independently by each section. Refer to your section s bylaws for details. Page 27

28 AAPS Committees AAPS Blog Committee (ABC) Committee Charge: The charge of the AAPS Blog Committee (ABC) is to help solicit and secure topical and timely content for the AAPS blog. Structure: The ABC will include seven (7) to nine (9) representatives from AAPS sections, committees, focus groups, discussion groups and/or student members and one member-at-large. The ABC representatives should have broad knowledge of and interest in current issues affecting pharmaceutical scientists and extensive experience using social media platforms. Prior blog experience preferred. Annual Meeting Program Committee (AMPC) Committee Charge: The charge of the Annual Meeting Planning Committee (AMPC) is to select the theme of the plenary session, as well as the content, programming format, and the time schedule for programming activities of the Annual Meeting and Exposition. The committee also selects the keynote and plenary session speakers. Committee Membership: The committee is comprised of a chair and co-chair, both of whom are selected by the AAPS President. The chair serves a one-year term and the co-chair serves as chair in the second year of his/term term. Other members of the committee consist of the past chair, a representative from each AAPS Section (the section chair-elect), an Executive Council Liaison and a Staff Liaison(s). Meeting Schedule: The AMPC meets face-to-face at the Annual Meeting Summer Jamboree, the annual meeting, and one time just prior to the annual meeting. The committee also holds conference calls as necessary. Annual Meeting Screeners Committee Committee Charge: The charge of the Annual Meeting Screeners Committee is to review all contributed papers submitted for presentation at the AAPS Annual Meeting and Exposition. The committee will evaluate the contributed papers based on criteria published in the AAPS Call for Papers. Committee Membership: The committee is comprised of the chair, (the current Annual Meeting Planning Committee Chair), a representative from each section, an Executive Council Liaison, and Staff Liaison(s). The section representatives serve a three year term. Meeting Schedule: The Annual Meeting Screening Committee generally meets face-to-face at the annual meeting and holds two to three conference calls per year. Page 28

29 Awards Committee (AC) Committee Charge: The charge of Awards Committee (AC) will be to provide recommendations regarding structure and procedures for section, non-section awards, and travelships. This includes but not limited to reviewing awards for potential overlap; recommendation to discontinue awards, if needed; recommendations regarding strategies to increase award applicants; streamlining the award application process; and recommendations on how best to fund awards, monetary guidelines and ranges and provide resources and guidelines for sponsor funds. Committee Membership: The committee is comprised of a chair and the chair-elect, both of whom are appointed by the AAPS President-elect. The chair serves a one-year term and the co-chair serves as chair in the second year of his/her term. Other members of the committee consist of a representative from each AAPS section (appointed by the section leadership), an Executive Council liaison and a staff liaison(s). All members appointed to serve on the AC should be comfortable with fundraising activities. It is recommended that committee representatives serve a three-year term (staggered terms). Meeting Schedule: The AC meets face-to-face during the AAPS Annual Meeting and Exposition. The committee also holds conference calls monthly or as necessary. Fundraising Experiences: Committee members should have broad knowledge of and interest in fundraising, such as fundraising networking; exposure to and understanding the awards process or serving on an awards committee; and the ability to make recommendations as needed. Content Advisory Committee (CAC) Purpose: The AAPS Newsmagazine Content Advisory Committee (CAC) is responsible for soliciting and securing topical and timely content (e.g., feature articles, news briefs) for the AAPS Newsmagazine. It is the aim of the CAC to help bolster the stature of AAPS Newsmagazine, both to readers and advertisers. Structure: The CAC will include one representative from each AAPS section and one member-at-large. CAC representatives should be past or present section leaders who have a broad range of personal and professional contacts within their sections and research communities. CAC members serve for three years and each year three members rotate off the committee as new members join. The members are recommended and asked by their section leadership to serve. Function: CAC members will collaborate with the AAPS Newsmagazine Managing Editor and the AAPS Director of Publishing to create and support the magazine s editorial calendar. The editorial calendar will feature topics of interest to the AAPS membership and pharmaceutical community. Each issue will have, at least, one feature topic. CAC members are responsible for contacting scientists in their section whose area of expertise or research is of interest to the pharmaceutical sciences community. During the months of February, March, April, June, July, August, September, and December a CAC representative is responsible for the content of one particular issue. For the October/November issue of the AAPS Newsmagazine, CAC members are asked to submit a preview of their sections programming for the annual meeting. CAC members are likewise asked to contribute copy on the highlights of the annual meeting held the previous fall for the January issue of the AAPS Newsmagazine. Page 29

30 Meeting Schedule: Monthly teleconferences, typically scheduled on the second Thursday of each month from 3:00 to 4:00 pm EST, and one (1) face-to- face meeting at the AAPS Annual Meeting and Exposition will be held each year to discuss, develop, and ensure that assignments meet posted deadlines. Electronic Program Development Committee (EPDC) Committee Charge: The charge of the Electronic Program Development Committee (EPDC) is to solicit and select the theme (e.g. BT 101) as well as the individual lecture content, programming format, appropriate presenters/reviewers and evaluation criteria for on-demand, web-based AAPS elearning Courses and webinars. Committee Membership: The committee is comprised of a chair and the section chair-elect, both of whom are selected by the AAPS President, with EC consensus. The chair serves a one-year term and the co-chair serves as chair in the second year of his/her term. Other members of the committee consist of the past chair, a representative from each AAPS Section (the section chair-elect), an Executive Council Liaison and a Staff Liaison(s). Meeting Schedule: The EPDC meets face-to-face at the Annual Meeting Summer Jamboree and during the AAPS Annual Meeting and Exposition. The committee also holds conference calls monthly or as necessary. A subcommittee of members will meet quarterly via conference call with members of the PCC, AMPC and NBCPC to discuss new programming ideas. elearning Experiences: Committee members should have: Broad knowledge of and interest in current issues in pharmaceutical science education, such as perceived training gaps, cutting-edge techniques or innovations in the field Exposure to and understanding of the AAPS programming process (i.e., workshops, open forums, annual meeting, webinars) Active interest in the elearning and meeting programs AAPS Ability to attend and participate in conference calls, section meetings, Annual Meeting jamboree, and Annual Meeting ecourses: Designed to address perceived training gaps in the pharmaceutical and biopharmaceutical sciences. AAPS ecourses are comprehensive online offerings that provide the convenience of self-paced learning. Facilitated by top researchers in the field, these ecourses provide practical perspectives from practicing scientists, and allow participants the opportunity to receive a Certificate of Completion. The material covers a broad topic in-depth, often with multiple lectures available under a particular subject area. A new committee, possibly named the Electronic Program Development Committee (EPDC) will formulate and review potential educational ecourses. Page 30

31 Fellows Committee Committee Charge: The charge of the Fellows Committee is to select AAPS Fellows as submitted through the AAPS Fellows Nomination process. Committee Membership: The committee is comprised of a chair selected by the AAPS President, a representative of each AAPS Section, an Executive Council Liaison and Staff Liaison(s). The chair and section representatives must be AAPS Fellows and serve a three-year term, with approximately 1/3 of the members rotating off each year. Meeting Schedule: The Fellows Committee meets one day a year, generally in June, to review the nominees and make final selections and recommendations to the Executive Council. Finance Committee Committee Charge: To study issues relating to fiscal management of the association s resources, identify additional sources of revenue, assess the cost-effectiveness of AAPS offerings, and make related policy recommendations to the Executive Council. Committee Membership: The committee is chaired by the AAPS Treasurer (elected position) and its members serve a three-year term. Six additional members are appointed by the Treasurer from the general AAPS membership. Meeting Schedule: The Finance Committee meets face-to-face three times per year and by conference call throughout the year on an as needed basis. International Affairs Committee (IAC) Committee Charge: The charge of the International Affairs Committee (IAC) is to increase globalization efforts on behalf of AAPS. The IAC works in conjunction with FIP, APSTJ and FPTI to offer regulatory science and educational/tutorial workshops to developing countries. The IAC approves all international meeting proposals, develops strategies by which AAPS can serve pharmaceutical scientists world-wide, and works together cooperatively in partnership with other organizations to develop mechanisms for better exchange of information. The IAC works as a facilitator of a global communication network. Committee Membership: The chair(s) are selected by the President-elect. Members include a representative from the APSTJ or FPTI and the chair or chair-elect of the FIP/BPS, a representative from the following countries: South Africa, India, China/Taiwan, Australia, Mexico, Central or South America, Canada, Europe, and the U.S.; a member of the World Health Organization, an Executive Council Liaison, and the AAPS Executive Director and the Director of Meetings and Expositions. The AAPS Presidentelect is asked to serve on the committee. Meeting Schedule: The IAC meets face-to-face at the AAPS Annual Meeting and at the FIP Annual Meeting. When FIP/BPS holds its Pharmaceutical Sciences World Congress, the committee will meet there in place of the FIP Annual Meeting. All other communication will be by throughout the year. Page 31

32 Member Groups Coordination Committee (MGCC) Committee Charge: The MGCC is charged with reviewing the operations and effectiveness of the sections, focus groups, and discussion groups, as well as the interaction between the member groups. Committee Membership: The chair of the committee is the AAPS President-elect and additional members include three section representatives, three focus group representatives, two discussion group representatives, and staff liaison(s). Members are selected by presidential appointment for staggered two-year terms to aid in promoting continuity in the group. Meeting Schedule: The committee meets face-to-face at the annual meeting and by conference calls during the year. Membership Strategic Oversight Committee (MSOC) Committee Charge: identify the demographic parameters necessary to provide profiles of member and non-member participants in key AAPS activities that will facilitate regular monitoring of who AAPS is serving and will facilitate the identification of threats and opportunities, with respect to both continuing member/nonmember participation and new member recruitment and to evaluate the above data annually and develop recommendations based on the threats and opportunities identified; periodically (3-5 years) develop and conduct a member satisfaction survey to be evaluated together with the data generated annually and to develop recommendations for membership recruitment, as appropriate, retention, enrichment of benefits, etc. based on the findings; to use the results of the 1999 and the 2002 surveys, as appropriate, in developing and evaluating the next survey; identify disciplines/organizations complementary to AAPS core membership through the database described above and other appropriate means, and to develop strategies to facilitate interactions with the individuals/groups identified and thereby fulfill the AAPS vision and enrich our membership benefits; identify comparable/competitive organizations against which to benchmark member benefits, dues, meeting registration fees, etc; to annually develop recommendations to address critical gaps identified; facilitate periodic evaluation of the section/focus group offerings with respect to the data generated and the strategies recommended above; develop recommendations to fully leverage the student chapters to further the charge of the committee; set up a process where non-members who interact with AAPS through workshops, meetings, presentations, or submitting papers and articles, are recorded and profiled in order to identify other disciplines that have natural links to AAPS. Committee Membership: The chair of the committee is appointed by the AAPS President and must be a member of AAPS. The chair serves in a non-voting capacity for a term of three years. Additional members of the committee consist of a representative from each AAPS Section (voting members), one student representative appointed by the chair (voting member), one discussion group representative appointed by the chair (voting member), an Executive Council Liaison (non-voting member) and a Staff Liaison (non-voting member). Voting members serve staggered three year terms. Meeting Schedule: The MSOC meets by conference call the second Thursday of each month at 2:00 pm ET, as well as face-to-face at the annual meeting. Page 32

33 National Biotechnology Conference Program Committee (NBCPC) Committee Charge: The charge of the National Biotechnology Conference Planning Committee (NBCPC) is to select the content, programming format, and the time schedule for programming activities of the annual National Biotechnology Conference. The committee also selects the keynote and plenary session speakers. Committee Membership: The committee is comprised of a chair and co-chair, both of whom are selected by the AAPS President. The chair serves a one-year term and the co-chair serves as chair in the second year of his/term term. Additional members of the committee consist of the past chair, a representative from each AAPS Section, a representative from the FDA, and an Executive Council Liaison and a Staff Liaison(s). Meeting Schedule: The committee meets face-to-face at the National Biotechnology Conference and the annual meeting and holds monthly conference calls. National Biotechnology Conference Screeners Committee Committee Charge: The charge of the National Biotechnology Conference Screeners Committee is to review all contributed papers submitted for presentation at the AAPS National Biotechnology Conference. The committee will evaluate the contributed papers based on criteria published in the AAPS Call for Papers. Committee Membership: The committee is comprised of the chair, (the current National Biotechnology Conference Planning Committee Chair), a representative from each section, an Executive Council Liaison and Staff Liaison(s). All section representatives serve a three year term. Meeting Schedule: The committee generally meets face-to-face at the National Biotechnology Conference and holds two to three conference calls per year. Page 33

34 Nominations Committee Committee Charge: The charge of the Nominations Committee is to seek, identify, and nominate the best candidates for the AAPS national offices, including the AAPS Executive Council President, Treasurer, and Members-at-Large. It is the responsibility of the Nominations Committee to conduct a fair and balanced review and selection from all of the nominations put forward by AAPS members and to ensure there are appropriate and qualified to serve the association. Committee Membership: The composition of the AAPS Nominations Committee includes the chair, who is the past president who has most recently served as the immediate past president, the current immediate past president who will chair the committee the next year, the past nominations committee chair, one or two Executive Council Member-at-Large(s), depending on term of member-at-large, the chair of each AAPS Section, and a Staff Liaison(s). AAPS Past President (Nominations Committee Chair); Second year of a three year term on Nominations Committee; no longer an officer or member of the AAPS Executive Council) AAPS Immediate Past President ¹ (First year of a three year term on Nominations Committee; still a member of the AAPS Executive Council) AAPS Past Nominations Committee Chair ¹ (AAPS Past-Past President; Third year of a three year term on Nominations Committee; no longer an officer or member of the AAPS Executive Council) AAPS Executive Council Member-At-Large ¹ ² (First year of a two year term on Nominations Committee) AAPS Executive Council Member-at-Large ¹ (Second year of a two year term on Nominations Committee) 1 Year Term: APQ Section Chair, BIOTEC Section Chair, CPTR Section Chair, DDDI Section Chair, FDD Section Chair, MSE Section Chair, PPB Section Chair, PPDM Section Chair, RS Section Chair AAPS Executive Director (standing member, non-voting) AAPS Staff Liaison (standing member, non-voting) Meeting Schedule: The committee meets by conference calls, beginning in November/December and continuing through February/March. Program Coordination Committee (PCC) Committee Charge: The charge of the Program Coordination Committee (PCC) is to evaluate and make recommendations to the Executive Council on meeting proposals other than the annual meeting and National Biotechnology Conference. The PCC is charged with clustering as many proposals as possible. Committee Membership: The committee is comprised of a chair (the past Annual Meeting Planning Committee chair) and a co-chair (the current Annual Meeting Planning Committee chair). The chair serves a one-year term and the co-chair serves as chair in the second year of his/term term. Other members of the committee consist of the past chair, a representative from each AAPS Section (either the section chair, chair-elect, or past chair), a representative from the FDA, and an Executive Council liaison and a staff liaison(s). Meeting Schedule: The Program Coordination Committee meets quarterly by conference call, generally two weeks prior to the Executive Council calls/meetings. Page 34

35 Publications Committee Purpose: The AAPS Publications Committee is charged with making recommendations to the AAPS Executive Council (EC) relating to the following matters: Formulation of an overall long-range vision of the Publications program, as well as tactical plans for its implementation; Evaluation of the quality of all AAPS Publications (including all AAPS scientific journals, AAPS Pharmaceutica [or Portal], AAPS Newsmagazine, and Book Program) and recommendation of possible avenues for improvement; Advising on, in conjunction with the AAPS Finance Committee, all budgetary issues relating to all AAPS Publications; and Selection of editors-in-chief for all AAPS Publications, subject to contract agreements. Membership: The voting members of the committee shall be comprised of AAPS Section representatives who are selected from nominations, plus one sitting EC member appointed by the EC. The non-voting members of the committee shall comprise of the editors-in-chief of the AAPS journals, 1-3 consultants (on an as needed basis and possess scholarly/scientific publishing experience), and appropriate staff. Each voting member shall serve a threeyear term, except for the EC member who may serve a shorter term at the pleasure of the EC. Each AAPS section will be requested to nominate 2 candidates per year. Nominations from other sources will also be considered. Selections will be based primarily on relevant publication experience (see Appendix A). The committee chair will be designated by the AAPS President-Elect prior to the Annual Meeting, and will serve a three (3) year term, the first year serving as Chair-Elect, the second as Chair, and the final year as Past-Chair. The Committee may constitute subcommittees to deal with important elements of the publication portfolio of AAPS, including but not limited to, the Book Program and AAPS Pharmaceutica, or Portal. Publication Experiences Exposure to and understanding of the scientific publication process (i.e., journals and/or books) through one or more of the following experiences: record of research publications in an area of pharmaceutical sciences or scholarly publications in pharmacy professional journals as an Editor, an Associate, Section or Field Editor, a member of an Editorial Board/Editorial Advisory Board, or regular reviewer of a recognized journal or monograph series in pharmaceutical sciences or pharmacy profession Knowledge of and interest in current issues in scientific publishing, such as information technology, open access, journal impact factor, ethical conduct in publishing, and conflict of interest Active interest in the scientific publication program of AAPS Financial Experience Committee member should be able to appreciate the impact of a major publication program on the operations and financial health of the Association. They should also be able to effectively weigh the financial costs of programs relative to member benefit Fiscal experience in either for-profit or non-profit organization is desirable but not necessary Other Relevant Experiences Prior leadership experience in AAPS or other volunteer organization Administrative or managerial experience Page 35

36 Student/PostDoc Outreach and Development Committee (SPOD) Committee Charge: The purpose of the SPOD Committee is to: address issues of concern to graduate and undergraduate students and postdoctoral fellows in the pharmaceutical and related sciences; sponsor broad-based industrial/academic programs of interest to graduate and undergraduate students and post-doctoral fellows; facilitate interaction between established pharmaceutical scientists and graduate and undergraduate students and post-doctoral fellows in the pharmaceutical and related sciences; foster a professional commitment to the organization by graduate and undergraduate students and post-doctoral fellows through active participation in AAPS activities; and further evolve programs for the continuing educational needs of all AAPS members. Committee Membership: The committee includes three officers: The chair, the chair-elect, and past chair. These officers serve one year terms on a calendar year basis. A new chair-elect is selected within the first three months of the chair s term, in consultation with the AAPS President-elect. The chair-elect assumes the office of chair at the end of the year as chair-elect. The outgoing chair assumes the office of past chair for one year. If the office of chair becomes vacant, the chair-elect shall serve as chair for the remainder of the term. At the end of that term, the chair-elect will continue responsibilities as chair, and a new chair-elect will be selected. Additional members of the committee consist of at least one member from each AAPS Section, up to two graduate students, and up to two members-at-large. Section representatives are appointed by their section chair to represent the section. Graduate students members are selected by the committee. Members-at-large may be appointed at the discretion of the chair. Student members serve staggered two year terms; other members serve staggered three year terms, ideally with one-third of the committee rotating off each year. Meeting Schedule: The committee meets at the annual meeting and holds other face-to-face meetings as necessary. The committee also conducts monthly conference calls. Page 36

37 AAPS Fellows Selection Process AAPS has a strong commitment to the recognition of select members through their designation as Fellows. Such designation constitutes an award program which duly recognizes individuals for outstanding contributions and which elevates the stature of the pharmaceutical sciences. Fellow status should be based on professional competence, peer recognition, and leadership in the pharmaceutical sciences. It is also the conviction of AAPS that recognition of Fellows should be reflected through all sections of AAPS. DEFINITION OF AN AAPS FELLOW: An AAPS Fellow is defined as a distinguished AAPS member who is an acknowledged leader and outstanding contributor to the pharmaceutical sciences and who has been elected to Fellowship status by the AAPS Executive Council. ELIGIBILITY REQUIREMENTS: The primary criterion for selection as an AAPS Fellow is professional competence that is reflected through scholarly and research contributions to the pharmaceutical sciences such as original articles, scientific presentations at annual meetings and/or patents. Evaluations will be based on merit, rather than quantity, and upon the impact of the nominee's contributions as evidenced by influence on the way others think and act. Evidence of peer recognition should be sought through a variety of indicators such as: research and other types of achievement awards, invitations to speak and/or organize symposia at annual and international meetings, and/or citation analysis. Recognition of the nominee as a leader in the pharmaceutical sciences is evidenced by election and appointment of offices and committees of national and international organizations. Specific service contributions to AAPS and other scientific organizations/associations will be considered as part of the nominee's leadership activities. NOMINATION PROCEDURE: Any member of AAPS can nominate candidates for Fellow status. Nomination materials to be submitted include: 1. Nominee Information Sheet 2. Nominee's current curriculum vitae 3. Nominee's Assessment Abstract (1-2 pace summary of why the nominator feels the nominee meets eligibility requirements), not to exceed two, single-spaced, typed 8 1/2" x 11 pages. 4. Two Letters of Recommendation (If more than two are provided, only the first two will be distributed to the review and selection committees.) SELECTION PROCEDURE: AAPS Sections will form Section Review Committees comprised of three to five members that will receive the nominations from the membership. This committee is also charged with nominating worthy candidates for Fellow status. Nominations received at the AAPS Office will be forwarded to the appropriate Section Fellows Review Committee for consideration. Only current AAPS Fellows shall serve on Section Review Committees. The candidates forwarded through open solicitation and the Section Review Committees will be evaluated by the AAPS Fellows Selection Committee, which will be comprised of a Chairman and a representative of each Section. Only current AAPS Fellows shall serve on the AAPS Fellows Selection Committee. Page 37

38 SELECTION GUIDELINES: 1. In selecting Fellows, eligibility criteria should be assigned weighted values. Professional excellence should comprise a minimum of 50% of the evaluation; peer recognition and leadership should be accorded a maximum of 25% each in determining eligibility. 2. Fellows Section Review Committees (FSRCS) will generally consist of five members of the Section, all of whom are current AAPS Fellows. In the case in which five Fellows familiar with the professional focus of members of the Section are not available (e.g., new Sections), the Chair of the Section will appoint appropriate members to the FSRC. 3. FSRCs are charged with nominating candidates and for stimulating the nomination of candidates by individual members of the Section. Upon completion of the nomination process, the FSRCs will act to approve candidates for Fellow status. There will be a ballot on each nominee; the nomination dossier and the tally of the ballot for each nominee approved will be forwarded to the AAPS Fellows Selection Committee. Note: It is suggested that the votes for approval of nominees by the FSRC be done by secret ballot). All Section Review Committees must rank final candidates in order of preference (#l being top priority) before candidates are submitted to the Fellows Selection Committee. 4. The Chair of the AAPS Fellows Selection Committee (AFSC) is appointed by the President. Membership of the AFSC shall be comprised of one member from each Section appointed by the Chair of the Section. Approval of a candidate for Fellow status shall be by a majority vote of the AFSC. Section members of the AFSC will have responsibility for presenting credentials of the nominees from their Sections. All Section representatives will be allowed to vote on all nominations. 5. The AFSC will review all candidates recommended for consideration by the FSRCS. There will be a ballot cast for each candidate and a majority vote will be required for approval. The AFSC will forward its recommendations to the Executive Council. The AFSC is charged to assure that Fellow eligibility standards are applied uniformly across Sections. (Note: It is recommended that the vote on candidates by the AFSC be conducted by secret ballot.) 6. The business of the AFSC must be conducted at a meeting of the Committee convened for that purpose. 7. The Executive Council gives final approval to all candidates for Fellow status. Where conflicting recommendations are received from FSRC and the AFSC, the Executive Council will serve as final arbiter. 8. Unsuccessful nominations may be held over to the following year with an option for the nominator to resubmit, update, or withdraw the nomination. GENERAL INFORMATION The nomination dossier should form the primary basis upon which the final decision of the respective Committees is based. Verbal presentations should serve only to clarify specific aspects of the candidate's qualifications embodied in the dossier. ELECTION PROCEDURE A. Mechanics Immediate Past Chair works with section representatives to encourage applications. Section Fellows Committees solicit nominations. AAPS Staff receives and collates nominations. Page 38

39 Staff review assuring application completeness: Forward nominations to sections Section selection: 1. Rank candidates 2. Employ classification system, (Outstanding, Excellent, Qualified). 3. Forward ranked candidates to AAPS Staff AAPS Fellows Committee Chair & Chair Elect assigns primary & secondary reviewers. Staff assures random selection for presentation at meeting Staff takes notes during the proceeding. Staff clears nominations with EC. Staff prepares notification letters. 1. Elected Fellows.President s Signature. 2. Failures..Fellows Committee Chair s Signature. Letters cleared through the Section s representative. B. Meeting Conduct (Robert s Rules) Chair is responsible for assuring meeting is conducted in a professional manner. Introduction of section representatives and Staff. Chairs Instructions. 1. Process is evolutionary Committee gels after several nominees have been considered. (1 st nominations tend to be looked at more closely). 2. To assure full & fair consideration, all close vote failures are reconsidered. All committee members vote (even if they are the nominator). Reclusion is a member s personal decision, not the chair s. All section representatives and EC Liaison must be present at the face-to-face meeting. If the representative cannot attend, they must find an alternate to attend. C. Process Section representative discusses the sections consideration of their nominee, presenting the case for election of nominee to Fellow. Primary Reviewer gives his/her thorough evaluation of candidate. Discussion, if appropriate. Secondary reviewer gives his/her evaluation of candidate. Discussion. Chair holds vote (all committee members vote). Majority vote required for election. Election/failure to elect recorded by staff. Reasons for failure to elect are agreed to by chair, committee and section representative. Staff records in writing to include in letter to nominator. After all candidates have been considered, candidates that failed to win election by close vote are reconsidered so as to assure fair evaluation. Meeting is adjourned Results sent to EC by Staff for EC approval Elected Fellows notified by AAPS President Letters to those not elected are prepared by staff for AAPS Fellows Selection Committee Chair s signature and cleared through section representative to assure clarity and lighten the blow to the failed candidate. Page 39

40 Summary of Fellows Selection Process The BIOTEC Section created the following charts to assist with the AAPS Fellows selection process by creating more structure to the nomination and selection process within the BIOTEC Section. We hope it is helpful to other sections as well. Solicit Nominations [internal / external AAPS] Applicants / nominators review guidelines Section Fellows Committee screens list of potential candidates Applicants submit CV and brief bio Applicants develop submission packet per formal Section Fellows Committee reviews and ranks pool of candidates Rejected Candidates Section Fellows Committee submits ranked list of candidates to AAPS AAPS Fellows Committee screens list of potential candidates AWARD AAPS FELLOW EVALUATION FORM BIOTEC SECTION RANKING Candidate Ranking Professional Excellence / Rationale Sample Candidate 1 Special internal awards/recognition for R&D-related achievements 2 IND s, NDA s and Related Contributions 3 Adjunct Faculty Positions in Universities 4 Service to AAPS or Other Professional/Scientific Organizations 5 Service as Editor, Associate Editor, etc. for Learned Journals in the Pharmaceutical or Related Sciences 6 Presentations Page 40

41 Discussion Items for Section Conference Calls Conference Call Agenda Guide The following conference call agenda guide is a general outline of discussion items for monthly section conference calls. This may be helpful to ensure all topics are being covered each month. Discussion items for the monthly calls should include: Focus Group Reports Executive Council Liaison Reports AAPS Committee Reports o AAPS Blog Cmte (ABC) o Annual Meeting Program Cmte (AMPC) o Annual Meeting Screeners Cmte (AMSC) o Awards Cmte o Content Advisory Committee (CAC) o Electronic Program Development Cmte (EPDC) o Fellows Cmte o Membership Strategic Oversight Cmte (MSOC) o NBC Program Cmte (NBCPC) o NBC Screeners Cmte (NBCSC) o Program Coordination Cmte (PCC) o Publications Cmte o Student/PostDoc Outreach & Development (SPOD) Cmte You may want to consider alternating the committee reports or eliminating some from the monthly agendas if activities are not timely or have ended. Section Committee Reports (i.e., Awards, Communications, Membership, Open Forum, Strategic Visioning, Webinars, etc...) NOVEMBER Discussion Topics Date URL PPB Newsmagazine Copy Deadline (for the Jan 2014 issue) Nov 1 DECEMBER RS Newsmagazine Copy Deadline (for the Feb 2014 issue) Dec AM Event Submission Site Closes Dec AM Workshop Submission Deadline Dec 4 kshops 2014 NBC Hot Topic Submission Site Closes Dec 11 AAPS EC President-elect & Member-at-Large Nomination Deadline Jan 24 Fellows Nomination Deadline Mar 21 JANUARY Quarterly Section Financial Report ed to Section Officers FDD Newsmagazine Copy Deadline (for the Mar 2014 issue) Jan 3 AAPS EC President-elect & Member-at-Large Nomination Deadline Jan 24 Page 41

42 FEBRUARY MARCH APRIL MAY PPDM Newsmagazine Copy Deadline (for the Apr 2014 issue) Jan NBC Contributed Papers Submission Deadline Feb 12 Fellows Nomination Deadline Mar AM Open Forum Submission Deadline Mar 28 President's Retreat (section chairs & chair-elects) Feb NBC Contributed Papers Submission Deadline Feb 12 BIOTEC Newsmagazine Copy Deadline (for the May 2014 issue) Feb 28 Fellows Nomination Deadline Mar AM Open Forum Submission Deadline Mar 28 Nominations Committee Call for Section Candidates Apr 11 Section Officers Work with Maria Nadeau to Finalize Section Budgets for the Next Fiscal Year Fellows Nominations due Mar AM Open Forum Submission Deadline Mar 28 Preparation for the 2015 NBC Jamboree, Chicago Hilton O Hare Apr 7-8 Nominations Committee Call for Section Candidates Apr 11 Awards Committee Encourage Submissions Apr/May Quarterly Section Financial Report ed to Section Officers Awards Committee Application Deadlines Apr/May NBC Jamboree, Chicago Hilton O Hare Apr 7-8 January and February 2015 Workshop Submission Apr 8 Deadline kshops Nominations Committee Call for Section Candidates Apr AM Contributed Papers Submission Deadline Jun AM Hot Topic Submission Site Deadline Jun 12 Awards Committee Application Deadlines Apr/May DDDI Newsmagazine Copy Deadline (for the Jul 2014 issue) May AAPS National Biotechnology Conference, San Diego May AM Contributed Papers Submission Deadline Jun AM Hot Topic Submission Deadline Jun NBC Programming Submission Deadline Jun 26 Preparation for the 2015 AM Jamboree, Hilton Jul Page 42

43 JUNE JULY AUGUST SEPTEMBER OCTOBER NOVEMBER Alexandria Old Town, Alexandria, VA Order Section Giveaways and Service Award Plaques for the AM Fellows Committee Face-to-Face Selection Meeting TBD MSE Newsmagazine Copy Deadline (for the Aug 2014 issue) Jun AM Contributed Papers Submission Deadline Jun AM Hot Topic Submission Deadline Jun NBC Programming Submission Deadline Jun NBC Workshop Proposal Submission Deadline Jun 26 kshops Chair-elect to Assign 2015 Section Committee Representatives Aug 4 Preparation for the 2015 AM Jamboree, Hilton Alexandria Old Town, Alexandria, VA Jul Quarterly Section Financial Report ed to Section Officers APQ Newsmagazine Copy Deadline (for the Sep 2014 issue) Jul 3 Arden Conference and Workshops in March and April 2015 Submission Deadline Jul 8 AAPS Elections Voting Deadline Jul 31 Chair-elect to Assign 2015 Section Committee Representatives Aug 4 Preparation for the 2015 AM Jamboree, Hilton Alexandria Old Town, Alexandria, VA Jul Annual Meeting Preview Copy Deadline (for the Oct/Nov 2014 issue) Chair-elect to Assign 2015 Section Committee Representatives Agendas for F2F Meetings at the AM FG & Committee Annual Reports Due to Section Officers Finalize Agendas for F2F Meetings at the AM CPTR Newsmagazine Copy Deadline (for the Dec 2014 issue) September 2015 Workshop Proposal Submission Deadline 2014 AAPS Annual Meeting and Exposition, San Diego Confirm Next Year s Conf Call Schedule Aug 1 Aug 4 Oct 3 Oct 7 Nov kshops Page 43

44 Important Dates The following schedule is an overview of when various activities occur. Please note that this is only a guide actual dates will differ year to year. JANUARY AM contributed papers submission site opens President s Retreat EC F2F Meeting FEBRUARY NBC contributed papers submission site closes Deadline for EC nominations MARCH Sections submit next fiscal year budget requests (includes section funds) NBC Jamboree submission site opens for the following year Deadline for section slate of candidates APRIL Begin working on AM Hot Topic proposals Solicit award applications MAY AM contributed papers submission site closes The chair-elect begins requesting the following year s committee representatives: due in August Finance Committee approves budget AAPS Nominations Committee presents final slate of candidates for election JUNE AM preliminary program opens online National Biotechnology Conference EC Budget Approval JULY NBC session submission site closes for the following year AAPS election ballot closes OCTOBER Call for Nominations listed in AAPS Newsmagazine AAPS Annual Meeting EC F2F Meeting AUGUST Committee representatives due to AAPS from the section chair-elect Leadership Retreat & EC F2F meeting Order annual meeting booth giveaways AM Jamboree submission site opens for the following year Announcement of election results NOVEMBER Nominations Committee begins series of conf calls New EC Members & Section Leadership begin term of office SEPTEMBER Finalize annual meeting details including presentations for the executive committee meeting and membership meeting. Invite volunteers to the executive committee meeting and members to the membership meeting. Request activity reports from the committee representatives and focus group chairs. DECEMBER NBC contributed papers submission site opens Sections begin considering next year s election candidates AM session submission site closes for the following year Page 44

45 Section Goals Worksheet AAPS has undertaken a strategic visioning process where each and every program, product, and service was evaluated to determine its adherence to the AAPS Vision, Mission, and Values. The AAPS Executive Council (EC) approved the following worksheet to track section goals alignment with the AAPS Vision, Mission, and Values. Focus groups should align goals with the section goals. This worksheet will be posted on the section webpage for public review and updating. Incoming section chairs are expected to complete this worksheet and present it to the EC for acceptance. This will also allow incoming chairs to continue with or expand upon existing goals. Page 45

46 AAPS Section Goals Section Name: Section Chair: Year: AAPS Vision - The American Association of Pharmaceutical Scientists will be the premier organization of all scientists dedicated to the discovery, development and manufacture of pharmaceutical products and therapies through advances in science and technology. AAPS Mission - The American Association of Pharmaceutical Scientists provides a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to health. We offer timely scientific programs, ongoing education, opportunities for networking, and professional development. AAPS Values: Communication - AAPS is committed to effective communication throughout the Association, with other organizations, and with the public. Inclusiveness - AAPS values diversity in its membership and scientific disciplines and promotes inclusiveness. Innovation - AAPS is committed to innovation in science and technology. Integrity - AAPS is committed to the highest standards of ethical conduct. Member Focus - AAPS is an organization driven by the needs of its members. Member Involvement - AAPS supports and encourages the active participation of all its members. Professional Development - AAPS values professional development through networking, mentoring, education and scientific exchange. Quality - AAPS is committed to promoting quality science and offering quality programming, publications, and other services to its members, the scientific community and the public. Instructions - When preparing annual Section goals attempts should be made to align each goal with the AAPS vision, mission, or values (VMV). To assist in this process please enter your goals into the following form and check off which VMV pertain to each goal. Multiple boxes may be checked for each goal. Goal 1. Vision..Comments/Notes: Mission Comments/Notes: Values.. Comments/Notes: Communication Comments/Notes: Inclusiveness...Comments/Notes: Innovation Comments/Notes: Integrity Comments/Notes: Member Focus.Comments/Notes: Member Involvement...Comments/Notes: Professional Development Comments/Notes: Quality..Comments/Notes: Page 46

47 Goal 2. Vision..Comments/Notes: Mission Comments/Notes: Values.. Comments/Notes: Communication Comments/Notes: Inclusiveness...Comments/Notes: Innovation Comments/Notes: Integrity Comments/Notes: Member Focus.Comments/Notes: Member Involvement...Comments/Notes: Professional Development Comments/Notes: Quality..Comments/Notes: Goal 3. Vision..Comments/Notes: Mission Comments/Notes: Values.. Comments/Notes: Communication Comments/Notes: Inclusiveness...Comments/Notes: Innovation Comments/Notes: Integrity Comments/Notes: Member Focus.Comments/Notes: Member Involvement...Comments/Notes: Professional Development Comments/Notes: Quality..Comments/Notes: Page 47

48 Section Webpages Minimum Requirements for Section Websites The section websites are regularly used by the members of all of the sections. However, there is a wide variety of items posted on the individual section websites. The Section Website Program Review Team set a consistent website format or framework for the sections to follow; this format or framework should allow flexibility for the sections to customize and individualize their sites. The items listed are not meant to limit sections as to what can be included. They represent minimum requirements. All section websites are required to contain the following items: Section description Section mission Section vision Annual goals Leadership list Committee lists Upcoming programming specific to section List of focus groups that have named the section as their primary or secondary section and hot links to the specific focus group websites ByLaws Minutes of meetings (post online for three years, then they will be archived by AAPS) Policy for Posting Material What is appropriate for posting? 1. General Section mission statement Section goals Membership: requirements, services, and member news Section by-laws Listserv access Meeting information: schedules (teleconference, face-to-face), agendas, and minutes 2. Science Published articles (full-text or links) written by section members Position papers Scientific critiques of current research or regulation with appropriate disclaimers Page 48

49 3. Career Development Section-related jobs (as links to AAPS Career Center job postings) Section-related career advice Mentoring advice 4. News and Discussion Listserv copy Chat room discussions Section e-newsletter (web publication of section news) News headlines, section-related (source AAPS news feeds) What is not appropriate for posting on a section website? Non-section-related material that is more appropriate for the association web pages Inflammatory language or positions Personal web logs (blogs) Job links to non-aaps related career sites Procedure for Posting Material on Section Websites Contact Maria Nadeau to post information online. Disclaimer - AAPS Policy on External Information Systems and Services AAPS cannot support or endorse the development, deployment and maintenance of information services, including, but not limited to, websites, threaded discussions, listservs and news feeds that are external to the AAPS IT domain. Individuals or groups associated with AAPS are encouraged to offer suggestions for the enhancement of existing AAPS information services and the development of new features. Suggestions should be submitted to Maria Nadeau. The impact and scope of proposed changes or additions will be assessed and discussed at the appropriate levels within AAPS. Page 49

50 AAPS Elections Executive Council A critical mission of AAPS is to sustain highly effective volunteer leadership for the association. These leaders need to understand the mission and vision of the association and be willing to commit time and utilize their unique perspectives to serve the association and its members. The AAPS Nominations Committee plays a vital role in seeking, identifying, and nominating the best candidates for the AAPS National Offices, including AAPS Executive Council President, Treasurer, and Members-at-Large. Full details about the Nominations Committee are provided in the Nominations Committee Composition and Procedures document that is available online at Sections Sections are responsible for providing nominations for vice chair [or secretary/treasurer] annually and for secretary/treasurer every two [or three] years. Nominations may be selected from the section s membership by nomination during the membership meeting or through correspondence with the membership. Individuals must be active AAPS members and a member of your section in order to be eligible to serve as a section officer. All nominations are subject to approval by the section s leadership. At least two candidates should be nominated for each office. All procedures for election of new officers shall be the same as those for the AAPS Executive Council elections as defined by the AAPS By-Laws. The winner will be determined by simple majority of the votes cast in the election. Focus Groups Focus group officers shall develop a slate of nominees for the elective office and notify AAPS and the leaders of the section with which the focus group is affiliated. The focus group shall then submit the names to the members of the focus group for vote by ballot or at the focus group membership meeting (held at the AAPS Annual Meeting), with each member having one vote for each office. The candidate receiving a plurality of votes shall be elected. Page 50

51 Finances Funding for Sections Funding for Sections 1) Sections a) Unrestricted Funds Available to All Sections i) Annual Allocations For fiscal year 2009 (FY09) only, allocation amounts for APQ, BIOTEC, CPTR, DDDI, PPDM and RS will be the same as the FY08 amounts. For the three new sections, FDD, MSE and PPB, the allocation amounts will be one-third of the sum of the PT and PDD allocations in FY08. FY10 allocation methodology will be determined when member section affiliation selections are completed. Contact Section Staff Liaison ii) Section Treasuries - All unexpended section funds at the end of the fiscal year will carry over to the next fiscal year and are included in the section Treasury. Contact Section Staff Liaison b) Restricted Funds Available to All Sections i) Conference Call Allowance A $1,200 annual conference calling allowance is available to each section. These funds are not eligible for carryover to the next fiscal year. Contact Section Staff Liaison ii) Student Travel Allowance A $2,000 annual travel allowance for student leadership of the section. These funds are not eligible for carryover to the next fiscal year. Contact Section Staff Liaison c) Available Resources i) Programming Support Programming submissions approved by AAPS programming committees (AMPC, PCC, NBCPC, etc) and the AAPS EC are included in the AAPS Meetings offerings as appropriate. Cost of attendance by Section Officers, Program Committee, and Focus Group Chairs at the Annual Meeting and National Biotechnology Conference Jamborees will be born by the AAPS. All logistics, marketing, funding, registration services, and other meeting support services are provided by AAPS. Contact Director of Meetings & Expositions ii) Webpage Development & Maintenance All sections are provided technical support to develop and maintain individual section webpages on the AAPS portal. For consistency and uniformity, certain standards will be maintained for all sections webpages. Contact Member Group Manager/Director of Technology iii) Listservs All sections have a moderated listserv which any AAPS member may join. Contact Member Group Manager d) Other Sources of Funding i) Open Forum Registrations several sections hold Open Forum events at the AAPS Annual Meeting and National Biotechnology Conference. Net proceeds from these events are included in the sections treasuries. Contact Director of Meetings & Expositions ii) Sponsors sections may solicit sponsors for funding of section activities and awards. Solicitations should be coordinated through the Associate Director of Meetings & Expositions. Contact Associate Director of Meetings & Expositions iii) Royalties some sections sponsor journals published by commercial publishers and royalties are paid to the sections based on subscription levels. Contact Director of Publications iv) Special Requests requests for funding or support of special projects may be submitted by sections to the Executive Council. Contact Section EC Liaison Page 51

52 Maintaining Section Treasuries 1. Approved funding of audiovisual, conference calls, food for section EC meetings, and scaled back receptions at AM 2. Approved funding for BIOTEC events at NBC as well due to strong contribution by Biotech members to the success of NBC 3. For those section with adequate reserves, approved augmenting expenditures for receptions by sections 4. Expected this subsidy to decrease in subsequent years as a) section leadership gained more expertise in managing their finances through training sessions, and b) additional sources of fund raising were identified in working with FC subcommittee 5. Recommended no change in the current section allocation amounts 6. Recommended the establishment of section treasury minimums to ensure sustainability of section activities 7. Supported funding section activities because section activities can potentially affect every member as opposed to other subsidized programs which may affect only a small number of members 8. Form a subcommittee comprised of two FC members and the Secretary/Treasurer from each section to review section finances, discuss above proposal if approved and review their plans for financial stability The EC approved the section finances proposal and abovementioned Finance Committee additions effective for the FY11 budget in April Student Travel Not to be confused with student travelships which are based in part on abstract submissions, $2,000 has been designated per section to support student representatives on each section s leadership and allow them to take part in on-site section meetings at the AAPS Annual Meeting and Exposition or National Biotechnology Conference. Section Quarterly Reports AAPS s quarterly financial reports to each section showing current section income and expenses versus the budget. Page 52

53 AAPS Focus Groups What is an AAPS Focus Group? AAPS members with a common interest in a specific discipline will be identified as a focus group. The creation of focus groups should be encouraged to promote emerging new areas of interest within AAPS. Focus groups may also serve as a vehicle to determine the interest in a particular discipline, thus preventing the premature establishment of an AAPS section that would not have enduring interest. Guidelines for the Organization of AAPS Focus Groups Individuals interested in organizing a focus group may petition the AAPS Executive Council for recognition as a focus group, provided that at least 50 AAPS members have expressed an interest in joining the proposed new focus group. Focus groups will reapply to the Executive Council every three years with a list of at least 50 members and a summary of the past three years activity. Cross-sectional membership in focus groups will be encouraged. Focus groups will have access to core and non-core programming, through the Annual Meeting Program Committee. Focus groups will not be represented on the Executive Committee of a section or the AAPS Executive Council. Initially, the AAPS Executive Council will appoint the chair of a focus group. Selection of a chair after the first year will be by the members of the focus group. Focus group chairs will be listed in the AAPS Membership Directory. Funds to support programming and organizational functions by the focus groups will be requested through the AAPS office and approved by the AAPS Executive Committee. Focus groups are encouraged to propose workshops and participate in the AAPS Annual Meeting and Exposition, the National Biotechnology Conference, and all other AAPS meetings. Focus groups are encouraged to serve as point groups for science policy issues. All outside funding must receive approval of the Executive Council. Page 53

54 Focus Group Officers The officers of the focus group are the chair, chair-elect, and a past chair and constitute the executive committee of the focus group. All officers must be AAPS members in good standing. Chair: Represents the focus group at AAPS meetings; direct the focus group and preside at its meetings; appoint committee members and committee chairs as necessary. Chair-elect: Acts as chair in the absence of the chair or as necessary. Past Chair: Acts as an adviser to the chair and chair-elect. Focus Group Chair Duties and Requirements Complete, sign and return Focus Group Operation Conditions, including any specific program goals, objectives and procedures per attachment B. Contact chair of affiliated section(s). Appoint focus group steering committee members. Coordinate focus group chair-elect election process (see attachment A, Operating Conditions). Elections may be conducted online or during the focus group membership meeting. Represent focus group at AAPS meetings. Meet with Chair of affiliated Section(s) at least once annually. Participate on monthly section conference calls for the sections affiliated with your focus group. Hold regular conference calls with your focus group officers and steering committee members. Coordinate focus group membership meeting held in conjunction with the AAPS Annual Meeting and Exposition. Work with your steering committee, section(s), and focus groups with similar interests to develop programming ideas. At least one programming idea should be submitted per year. This includes programming for annual meeting symposia, roundtables, seminars, workshops, short courses or themed meetings. Attend (or send a focus group representative) AAPS programming planning meetings called jamborees. A jamboree is held for the National Biotechnology Conference each spring and a second jamboree is held for the Annual Meeting each summer. This gives focus groups and sections an opportunity to share programming ideas and build collaborative sessions. Review and update focus group webpage as needed. Send out messages through the listserv to keep focus group members updated. Maintain focus group summary of activities which should include a schedule of meetings and events, copies of meeting minutes, and other materials that describe the focus group activities. Submit activity reports to your affiliated section(s) and AAPS staff at the annual meeting. Page 54

55 Focus Group Steering Committees Each focus group shall form a steering committee that consists of focus group members appointed by the chair. All steering committee members report to the chair and should also be prepared to respond directly to AAPS. The role of the steering committee is to ensure that the goals and objectives of the focus group are fulfilled. Time Commitment Except for attendance at the Jamborees and/or other meetings, the time commitment is less than an hour per week (on average) for those involved. Structure of the Steering Committee and Subcommittees Subcommittees may be formed to address the website, newsletter, and programming. The composition of the subcommittees would be left to the individual subcommittee chairs. The following is a suggested structure for the steering committee: Chair Chair-elect Past Chair Secretary Website Committee Chair Newsletter Committee (or Communication Committee) Chair Annual Meeting Programming Committee Chair NBC Programming Committee Chair (from a macromolecule background rather than small molecules) Other Programming Committee Chair (workshops, webinars, etc ) Page 55

56 Section & Focus Group Descriptions Based on feedback received during the Focus Group Chair Meeting in New Orleans, the attached document summarizing section and focus group descriptions was created in order to better facilitate collaborative programming. This information is also available online at under the Volunteer s Corner. Revised March 2014 SECTION Analysis and Pharmaceutical Quality (APQ) Biotechnology (BIOTEC) Clinical Pharmacology and Translational Research (CPTR) Drug Discovery and Development Interface (DDDI) Formulation Design and Development (FDD) Manufacturing Science and Engineering (MSE) Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Physical Pharmacy and Biopharmaceutics (PPB) Regulatory Sciences (RS) DESCRIPTION analytical techniques, regulatory and compendial issues, and assurance of quality research, development, and commercialization of new biotechnology-based pharmaceuticals therapeutics and clinical assessment of drugs and biological: experimental design, conduct and analysis of clinical trials; regulatory aspects of clinical trials and drug registration; risk assessment, therapeutic extrapolation from animals to humans; pharmacoepidemiology; drug interactions; and in appropriate populations, therapeutic efficacy/safety and response to alternative dosage forms focuses on issues at the critical interface between drug discovery and drug development; discovering, optimizing, and effectively transitioning preclinical candidates into the clinical development phase share experimental results, consider new formulation and dosage form technologies, and discuss issues and concerns regarding the design and development of formulations/drug products for all dosage forms application and advancement of science and technology to the process development and manufacture of pharmaceutical and pharmaceutically-related products including medical devices and active pharmaceutical ingredients biopharmaceutics, pharmacokinetics, pharmacodynamics, drug metabolism and transport of pharmaceutical products and therapies physicochemical and biological factors that impact the design and delivery of small molecules and biologics and focuses on preformulation, biopharmaceutics, drug absorption, nanotechnology, and drug delivery systems design and performance including targeted drug delivery regulatory compliance, GMP, clinical and pre-clinical practices; the legal aspects of pharmaceutical development; and protection of intellectual property Page 56

57 FOCUS GROUP Animal Pharmaceutics and Technology API Manufacturing Technology Bioanalytical Bioequivalence Biomarkers in Translational Medicine Biosimilars Chemistry, Manufacturing, and Controls (CMC) CMC Statistics Contract Research Organization (CRO) Dermatopharmaceutics Discovery Modeling and Simulation Drug Metabolism Drug Candidate Selection Drug Transport Excipients Generic Pharmaceuticals Inhalation and Nasal Technology In Vitro Release and Dissolution Testing Ligand Binding Assay Bioanalytical DESCRIPTION scientists in the animal health industry or involved in the veterinary pharmaceuticals field, and those who use animal models in the development of human drug products issues related to the manufacture of active pharmaceutical ingredients (API) chromatographic assays applied to quantitative and qualitative investigations of small and large molecules in biological matrices that support drug discovery and development scientific issues relating to the demonstration of bioequivalence and biosimilarity that allow for sound regulatory policy decisions; PK, statistical designs, and metrics for equivalence of different dosage forms how to translate in vitro and laboratory findings into clinical applications and to facilitate drug development (qualifying and fitness of use) biosimilars as a broad topic (bioanalysis, manufacturing, regulatory, trials design, etc.), allowing decisions to be made not just within a sub-specialty group, but to provide feedback/perspectives from all areas involved in the biosimilar pipeline technical and regulatory CMC topics associated with the development of pharmaceuticals utilization of appropriate statistical methodology issues of interest to CROs, partners, and customers including the industrysponsored, pre-clinical CMC (Chemistry, Manufacturing and Controls), as well as clinical research programs globally study of skin and associated structures, skin permeation technologies, topical and transdermal product development as well as members involved in cosmeceuticals, regulatory and marketing of these pharmaceutical products cross-disciplinary view on how modeling is applied in the drug discovery and preclinical space including medicinal chemistry, pharmaceutics, drug metabolism and PK, and toxicology all aspects of the biotransformation of chemicals and therapeutic agents as well as the conditions that influence metabolism and those that are affected by biotransformation processes integrated and cross-disciplinary view on assessing developability for compound selection and development, much in line with how it is actually assessed in the pharmaceutical industry state-of-the-art techniques to study drug transport and to enhance knowledge about the mechanisms of action of drug transporters understanding of excipients and their use in pharmaceutical formulations including understanding of excipient quality, functionality, drug-excipient interactions and regulatory considerations development and manufacture of generic pharmaceutics art and science of pharmaceutical inhalation aerosol and nasal drug delivery systems development of useful and standardized methods to meet the challenges of new dosage forms and to improve or encourage innovation of new methodologies, provide a more in depth understanding of the IVIVC technologies and issues pertaining to the bioanalysis of analytes by nonchromatographic assays, including binding assays, immunoassays, activityand cell-based assays Page 57

58 Lipid-Based Drug Delivery Systems Microdialysis Modified Release Nanotechnology Non-Clinical Dose Formulation and Analysis Nutraceutical & Natural Products Ocular Drug Delivery and Disposition Oral Absorption Pharmaceutical Trace Impurities Pharmaceuticals in Global Health Pharmaco-imaging Pharmacogenomics (PGx) Pharmacometrics Preformulation Process Analytical Technology Process Development use of lipid-based systems in drug discovery and product development to effectively overcome physical and biological barriers related to poor aqueous solubility and stability, membrane permeability, drug efflux and bioavailability sampling technique that permits collection of molecules in the interstitial fluid of various organs with minimal tissue damage; current applications and future potentials in quantitative drug research and development mechanistic understanding, formulation design & development, process development & scale-up, as well as the related regulatory aspects of modified release dosage forms control of matter on a scale smaller than 1 micrometer, normally between nanometers, as well as the fabrication of drug and gene delivery devices and diagnostics on this same length scale technical and regulatory topics associated with nonclinical dose formulation analysis; dosing of poorly soluble, poorly permeable drug substances, and analytical challenges drug discovery and development of nutraceuticals, dietary supplements, and natural products novel drug delivery system design for ocular applications; emerging trends in ocular pharmacokinetics such as the use of microdialysis technique for aqueous and vitreous humor kinetics; and cellular and molecular basis of ocular drug delivery (e.g., cell culture models, epithelial electrophysiology, drug efflux pumps, and cytochrome P450 isoenzymes) human oral absorption (e.g., species differences in permeability, gastrointestinal tract regional differences in permeability, intestinal metabolism, in vitro/in vivo correlations, compound library for oral absorption research) and regulatory topics associated with the impurities, especially genotoxic impurities, highly sensitive analytical methodology development, process development and genotoxicity tests for impurities/genotoxic impurities that are capable of controlling these impurities application of pharmaceutical sciences to the solution of global health issues amalgamation of imaging and pharmacology that provides additional information that could not otherwise be obtained using traditional techniques and allows for a more precise, faster and direct translation of data from a preclinical to clinical context genetic causes of individual variations in drug response; pharmacogenomics more broadly involves genome-wide analysis of the genetic determinants of drug efficacy and toxicity quantitative concepts of pharmacometrics in the discovery, development, regulatory approval, and market utilization of therapeutic agents characterization of physical and chemical properties of both small and largemolecule drug substances or drug products, and is performed at both the earlystage and mid-stage development in pharmaceutical development and manufacturing system for designing, analyzing, and controlling manufacturing processes through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials, to ensure final product quality design, development, analysis, and optimization of technical processes Page 58

59 Process Modeling and Simulation Protein Aggregation and Biological Consequences QbD and Product Performance Stability Sterile Products Systems Pharmacology Targeted Drug Delivery and Prodrug Therapeutic Protein Immunogenicity application of physics based (such as Discrete Element Models, Computational Fluid Dynamics, Finite Element Analyses), engineering and mathematical modeling (statistical models such as LVM) techniques to better understand, control, develop and improve pharmaceutical manufacturing processes (both API and DP) qualitative and quantitative aspects of aggregation of therapeutic protein products, to discuss and develop techniques to study aggregation and factors that cause aggregation and to discuss potential impact of aggregation including immunogenicity and for example kinetics, (bio) activity Quality by Design (QbD) paradigm and biopharmaceutics, and its potential impact on enhancing drug product quality issues with stability testing and interpretation of new regulatory guidances relating to stability testing of API and finished products science and technology of parenteral products including sterile products that cover a range of therapeutic entities from small molecules to large biologics drug action at the molecular, cellular, tissue, organ, organism, and population levels site-specifically deliver or activate the therapeutic compounds in the site of action interpretation, presentation and clinical application of immunogenicity, and pursue validation of the risk factors and underlying cause-effect relationships affecting the immunogenicity of therapeutic proteins Page 59

60 AAPS Discussion Groups What is an AAPS Discussion Group? Discussion groups are separate unincorporated entities affiliated with AAPS that further the tax-exempt purposes of AAPS and provide a local forum for interested members and non-members in a specified geographic area. Discussion groups are open to AAPS members and non-members. Discussion groups are given a tax identification number under the 501(c)(3) status, which allows them to set up bank accounts affiliated with AAPS. Besides income from meeting registration fees, they also receive financial support from AAPS ($3/AAPS member/year). Discussion groups must send financial and activity reports annually to AAPS. Discussion groups offer programming which furthers and serves the purposes of AAPS and shall use its best efforts to ensure that such programs are of the highest quality with respect to program content, materials, and logistical preparation. All activities and publications, including any uses of the AAPS name, logo, or copyrights, are subject to prior review and approval by AAPS. All contracts to hold or reserve facility or hotel space must be directed through AAPS for advance written approval of the AAPS Executive Director. Page 60

61 Discussion Group Meetings Most discussion groups hold quarterly dinner (evening) meetings each year. The meetings typically have one speaker and take place at a restaurant or company site to be cost effective. Attendees are charged a nominal ($25-$50) meeting registration fee to cover dinner, audio-visual expenses, and speaker travel expenses. These dinner meetings provide a unique benefit to the pharmaceutical community by offering networking in a specific geographic location. Discussion groups may also hold one or two day meetings with multiple speakers and may include contributed papers and exhibits. All sponsor solicitations must be coordinated through the AAPS Associate Director of Meetings and Expositions. Any meetings held at least one full day must be approved by AAPS in order to avoid conflict with meetings organized through the AAPS National Office. Considerable flexibility is afforded discussion groups in planning the events that best serve their geographic area. The following list of current AAPS Discussion Groups illustrates the variety of meeting choices afforded to them. Bay Area: quarterly dinner meetings with one speaker at each meeting Chicagoland: five-six meetings per year with one speaker at each meeting Indiana/Ohio: four meetings per year with one speaker at each meeting; these meetings rotate between Indianapolis and Cincinnati Kansas City: four-six meetings per year with one speaker at each meeting North Carolina Pharmaceutical: four meetings per year with one speaker at each meeting Northeast Regional: meets twice a year for a full day with four speakers, exhibits, and posters Philadelphia Pharmaceutical Forum: eight meetings per year with one speaker at each meeting Rocky Mountain: two full day meetings each year in April and July with speakers, focused sessions, exhibits, and posters; these meetings would potentially rotate between different cities in the region, such as Salt Lake City, Utah; Missoula, Mont.; Spokane Wash.; and Denver Southern California Pharmaceutical: nine meetings per year with one speaker at each meeting Southern Regional: one meeting per year (1 ½ - 2 day meeting) with multiple speakers; works with student chapters in planning the meetings and the meeting rotate locations (Arkansas, Louisiana, Mississippi, Tennessee) Western India/Mumbai: four meetings per year with one-two speakers; also held one symposium with five speakers To see a current list of discussion groups, to join a group, or to contact a discussion group chair, please visit Page 61

62 Communication Vehicles Conference Calls Sections and focus groups are encouraged to set up monthly conference calls in order to discuss current events and strategic planning. Focus groups are invited to attend these calls and give updates to the sections. Focus groups and section committees may require separate conference calls to discuss specific issues. Contact Maria Nadeau for a conference call number and code. The codes are used by multiple groups, so please check on the availability of the number before holding calls. Create a list of people to invite on the conference call. Each call should include section leadership, focus groups chairs affiliated with your section, the Executive Council liaison, and the AAPS staff liaison. One week before the call, send a reminder with the date, time, phone number/pass code, and meeting agenda. A second reminder should be sent the day of the conference call. Tips for Successful Teleconferencing Send a reminder for the teleconference (approximately one week before the call) Send a second reminder on the day of the call Prepare and distribute an agenda, including the dial in number and pass codes (sample agenda attached passcodes were removed due to confidentiality) Arrange minutes to be taken Be available a few minutes prior to the meeting to greet the participants Start on time Be prepared Take attendance with a roll call Introduce yourself each time before you speak. Ask others to do the same Use the mute button to avoid background noise (tapping, shifting papers, typing, side discussions) Speak clearly slow down if you are a fast talker Be aware of the impact of accents and slow down accordingly Stick to the subject be concise Try to avoid asking questions of all participants, as it is likely several will try to respond at the same time. Instead, ask the participants one by one for questions or feedback If the group gets off the agenda, refocus but take note of the side issue for later attention Assign follow-up when necessary Offer opportunity for final/closing comments Conclude on time Schedule next meeting Distribute minutes of meeting promptly (within one week) Page 62

63 Section Connection The AAPS Section Connection is intended to serve as a conduit for the exchange of information between the AAPS Executive Council (EC) and AAPS Sections. The information is assembled by staff following each EC meeting to provide a summary of pertinent actions that are relevant to section leaders. Likewise, the Member-at-Large will transmit important sectional information to the EC and use the AAPS Section Connection as the recording mechanism of section interests shared with the EC. The AAPS Section Connection is posted on each section s website. Surveys You may send surveys to your members to gather scientific data or to gather feedback to better meet their needs. Simply create the survey in a plain Word document. The AAPS Marketing Department will create an electronic version of the survey that automatically tabulates the results. Recipients receive a unique URL to complete the survey, so we cannot post one URL online for all site visitors to complete. If you are interested in sending a survey, please contact Maria Nadeau for assistance. AAPS Newsmagazine The AAPS Newsmagazine is the official member publication of AAPS and reaches over 12,000 of the world s leading pharmaceutical scientists. This publication delivers timely information, cutting-edge research, pertinent industry developments, and association news. Membership Meeting Sections and focus groups schedule membership meetings during the AAPS Annual Meeting and Exposition in order to inform your membership about various activities occurring throughout the year. Another goal of the membership meeting is to provide an opportunity for each focus group member to bring up issues and concerns directly to the steering committee. Page 63

64 Listserv The AAPS Listserv has been populated by the AAPS membership database with participants of various sections, focus groups, and discussion groups. The listserv is open to members and nonmembers. These may be joined by any member wishing to participate in a discussion to further the interest of other members. Please note members have the option of declining participation on the listserv. Contact Maria Nadeau for assistance with sending messages to the listserv. Social Media AAPS utilizes social media to strengthen relationships with current AAPS members and to develop relationships with other stakeholders, such as journalists, prospective members and pharmaceutical science students. Our use of social networking has helped to position AAPS as an unbiased thought leader in the pharmaceutical sciences. Posts on our social media sites vary in topic including scientific content, trend information, white papers, upcoming events, videos, conference coverage, and much more. Geared towards the pharmaceutical industry and current/potential AAPS members, AAPS leverages existing AAPS social media platforms including Facebook, Twitter, YouTube and LinkedIn to reinforce overall AAPS key messages, build relationships with target audiences and communicate the value of AAPS. Find us on: Facebook LinkedIn Twitter YouTube WordPress AAPS Blog The vision of the AAPS Blog is to provide timely and multiple perspectives on the issues affecting pharmaceutical scientists. The blog allows for readers to connect with AAPS leaders, staff, and membership and increases their knowledge base. Page 64

65 Review of Opinions and Summary Reports Guideline The American Association of Pharmaceutical Scientists (AAPS) has established a position of leadership among pharmaceutical scientists such that the opinions of AAPS groups and summary reports from AAPS-sponsored events may be disseminated. This guideline provides a general framework by which such opinions should be communicated, posted, or published, and the process by which the association will review such items for approval. Intent of the Guideline The scientific content of opinions by AAPS groups, or of summary reports from AAPS-sponsored events, is not the specific purview of AAPS. But to ensure that such reports reflect the majority of scientific views on the topic being discussed or described, it is the specific charge of the AAPS Executive Council to ensure that an appropriate process has been followed to achieve scientific consensus. This guideline details the process to ensure the content represents a viewpoint that is expressed by the majority of the authoring body, and reflects the general scientific views of association members. Guideline for Development 1. This guideline covers workshop reports, consensus documents, white papers, books, chapters, or any other written item that is intended to summarize the major findings and content of an opinion generated by an AAPS group or summarize the findings and content of an AAPSsponsored event. This guideline applies to any group sponsored in whole or in part by AAPS, and applies to any event sponsored in whole or in part by AAPS. 2. The purpose of these items should be to represent the best-founded scientific data and majority opinion of the scientists of the association. The content must be based upon the data and opinions formed during discussion at AAPS group meetings and events and not of an individual or select subgroup of individuals. Proceedings or compilations of scientific information by individual author(s) and contributor(s) do not fall under this guideline. 3. This guideline should be distributed to all members of the organizing committee at the outset of planning for any event or at the outset of any group deliberation. AAPS agreements to cosponsor a group or an event should state the requirement for AAPS to follow this guideline on any summary report or opinion. 4. The document should be written by the organizing committee of the event or a core group of participants in the forum from which the opinion emanates. An appropriate acknowledgment of all key contributors must be included in the work. 5. To the extent possible, prior to AAPS events or group meetings where an opinion or report is likely or is planned, group members who will write and review the item should be designated. 6. When feasible and in the best interest of the target audience, AAPS journals should be designed as the preferred vehicle for dissemination. 7. The summary report or opinion should have one key individual identified as the corresponding author. But a group of key individuals should be identified with expertise in the scientific area of specialty. These should include, when applicable, the participants from the event or group process and key scientists knowledgeable in the specific area. 8. The report or opinion should be widely distributed in draft form to a number of different individuals to be sure that all perspectives of AAPS are represented. In particular, the draft document should be sent to the chair of any AAPS Section, Committee, Discussion Group, or Focus Group within the scope of the general knowledge and review of the scientific content. A Page 65

66 reasonable timeframe for review must be allowed: at least one week but generally not more than three weeks. A list should be prepared of people who participated in the writing and the review of the report/opinion. Guideline for AAPS Review 1. A review form should be submitted with the final draft of the document for approval. 2. If the document is to be published in a peer-reviewed scientific journal, the corresponding author should submit it to an AAPS journal or, if to a non-aaps journal, first to the AAPS director of publications. If the document is to be published, disseminated, or communicated other than in a peer-reviewed scientific journal, such as a website open for public comment, then the principal contact should submit it to the AAPS director of public outreach. 3. If the document is submitted to an AAPS journal, the responsibility to judge its suitability for dissemination rests entirely with that journal s editor-in-chief, who may choose to consult with experts in the field, the chair of the Publications Committee, or the Executive Council, if appropriate. The decision and any feedback will go from the editor-in-chief to the corresponding author. 4. If the document is to be submitted to a non-aaps journal, the AAPS director of publications will submit the document to the AAPS Executive Council for review and approval, and will convey the decision and any feedback to the corresponding author. 5. If the document is to be published, disseminated, or communicated other than in a peerreviewed scientific journal, the AAPS director of public outreach will submit the document to the appropriate AAPS section, followed by the AAPS Executive Council for review and approval, and will convey the decision and any feedback to the corresponding author. APPROVED by the AAPS Executive Council: Page 66

67 AAPS Opinion or Summary Report for Executive Council Review Title: AAPS Group or Event: Consensus Process: Collaborators in Document Preparation: (list name and AAPS position, if any) Reviewers of the Scientific Content: (list name and AAPS position, if any) What journal, scientific body, government agency, or other publication will this document be sent to: Supporting Documentation (website, white paper, etc.) Contact Information: Date Submitted: Name: Phone: Address: Approved by EC: December 18, 2013 Page 67

68 AAPS Resources Leadership Contact Information Current contact information for all and committees may be found online at Specific links for the member groups have been provided below. SECTIONS FOCUS GROUPS STUDENT CHAPTERS DISCUSSION GROUPS NOTE: Discussion groups are interested in partnering with sections, focus groups, and student chapters for meeting ideas and speaker suggestions. If you have a meeting idea that can be held in conjunction with a discussion group, please contact the discussion group chair. AAPS Staff AAPS established a Member Groups Manager position to handle various issues related to maintaining successful member groups including management of member volunteers; facilitating member reporting and communication; and, providing member support. Maria Nadeau has filled this position and you may contact directly for assistance. Page 68

69 AAPS Meeting Planning & Preparation Preparing for the AAPS Annual Meeting & Exposition Sections should confirm dates and times of committee meetings, the membership meeting and the reception/luncheon. Audio-visual equipment and food and beverages orders should also be considered. The Meetings Department will contact you in July to confirm the details. Each section will be assigned a kiosk within AAPS Central (the AAPS booth in the exposition hall). Maria Nadeau will help with soliciting volunteers via the listserv to represent your section. The section should use this opportunity to recruit new members, promote upcoming section activities, and to sign up volunteers. Sections should order giveaways in August/September for the annual meeting. Maria Nadeau will send a product catalogue to you and will assist you with your order. Focus groups should confirm dates and times of their membership meetings and an announcement may be sent to the FG members via the listserv. Jamborees AAPS organizes meetings called Jamborees to help sections and focus groups develop programming for the annual meeting and National Biotechnology Conference. Section leadership and one representative from each focus group (the chair or a representative from the steering committee) are invited to attend. The NBC Jamboree is held in the spring and the AM Jamboree is held in the summer. The jamborees help you to gain support for your proposals and obtain other good ideas to strengthen the programming. General Overview of the Process: Specific Deadlines are Provided at the Jamboree 1. Jamboree is held one representative is required to attend from each focus group and the rep should come with proposed session topics and descriptions to share with the sections and FGs 2. Programming submission site opens at the jamboree 3. Submission site closes (just after the current annual meeting or NBC) submissions should include a title, description and organizer; also provide suggested moderators, speakers and speech titles 4. Programming committee reviews and selects sessions 5. AAPS staff sends notice to session organizers about the programming acceptance or rejection if your session is accepted, you are asked to confirm speakers and gather reimbursement/ complimentary registration requests 6. Confirm programming information (title, description, moderators, speech titles, and speakers) for the preliminary program and reimbursement/complimentary registration details with AAPS 7. Confirm session information for the final program, which is distributed on-site at the meeting Page 69

70 Programming Definitions Symposia: A 2½-hour program on a specific topic with 4 invited speakers plus 1 speaker selected from contributed papers or 4 invited speakers plus a panel discussion. Speakers presentations will be a maximum of 25 minutes and 5 minutes Q&A. Speakers are invited by the event moderator. Speakers abstracts are not screened and submitted separately from the contributed papers process. AAPS staff will request all speaker biographies and abstracts. Roundtable: A 2-hour program designed for small groups and open discussions moderated by 1-2 people. Speakers for Roundtables are invited and should be limited to 2-3. Speakers are invited by the event moderator and should present for no more than 10 minutes. The majority of the session should be dedicated to Q&A. Speaker abstracts are not required. Speaker biographies will be requested so the moderator can introduce the speaker. Hot Topics: A program typically held from 12:00 1:15pm on a specific topic with invited speakers. Topic should be a hot breaking issue. AAPS Staff will solicit suggestions for these from AMPC members in May. Program usually allows for 3-4 Hot Topic Sessions. Speakers are invited by the event moderator. Abstracts and biographies not required. Short Course: A 4 or 7½ hour course on a specific topic held pre or post annual meeting. Short courses are tutorial and interactive. Attendance is limited to 100 to ensure an interactive environment. All speakers are invited by the event moderator. Number of speakers is optimally 3-6 per day to encourage diversity in presentations. Speakers must provide handouts of their presentation for distribution to the attendees minimally 6 weeks prior to the meeting. Speakers are not required to submit an abstract, but must provide a biography. Any deviations from these guidelines must be approved by the AMPC Chair. Posters: A 3-hour program whereby contributed abstracts are selected and screened by the section screeners. Acceptance criteria and the AAPS Ethics Statement are outlined in the AAPS Call for Papers and on the contributed papers submission site. Papers are presented in a poster format by topic. Authors will be asked to be present at their poster during specific times for any questions attendees may have. Authors will not be reimbursed for any travel expenses and must pay a registration fee to attend the Annual Meeting. Submission of an abstract is considered a commitment to present if the paper is accepted. All selected abstracts are published in The AAPS Journal Supplement on the AAPS website. Poster/Podium: A 2½-hour program whereby up 6-8 contributed abstracts are selected and screened by the section screeners. Authors are asked to present their paper at the podium. Their paper will be displayed on a poster board inside the meeting room. All papers will address a specific topic. Authors will not be reimbursed for travel expenses and must pay a registration fee to attend the annual meeting. Sunrise Session: A program held from 7:00am-8:15am whereby a lecture on a specific emerging scientific topic is given. Designed to be more tutorial or instructive in nature. Page 70

71 Programming Submission Site Instructions MIRA System Step 1 Enter the event submissions site at You will be taken to this log in page. Create a login either by using your AAPS Member ID or selecting one of the Create New User links. Your previous MIRA USER ID will not work; you will need to create a new log in for (Please note that the images used in this presentation are from past meetings and are for example only. ) Step 2: Option 1 If you select the Create New User without an AAPS Member ID link, you will be brought to this page where you will create a login name and password. Step 2: Option 2 If you select the Create New User with AAPS Member ID link, you will receive an you re your User ID and password. Much of your information will be auto-populated if you use your member ID. Step 3 You may change your password after signing-in by selecting My Info in the upper right corner of the Events Home page. Page 71

72 Step 4 Fill out each category on this page. Select underlined hyperlinks for descriptions of session types and programming themes. Please enter proposed speaker names, country of origin and suggested presentation title by separating each entry by a semi-colon. Complete the process by clicking on the Submit Proposal button at the bottom of the page. Page 72

73 Step 5 The programming committee will review all event submissions. Sample Acceptance Letter Organizers will receive a letter notifying them about the results of the review process. Sample Non-Acceptance Letter Page 73

74 Step 6 Organizers of accepted sessions will be asked to go back into the event submission site to complete the proposal by giving more detail on the speakers and moderators. An address for each speaker or moderator will be necessary to start this process. The address creates a unique user account and prevents duplication of speaker information. Step 7 Once a speaker s address has been added, more detail on their presentation title and contact information will be required. After all speakers and moderator information has been inputted and saved, the submission will be considered complete. You will have opportunities to make changes to your entries during the process. Page 74

75 Organizer Guidelines 1. Organizers should avoid having multiple speakers from the same company. This could lessen your chance of the Program Committee accepting your submission. If speakers need to cancel immediately before the meeting, the Program Committee will accept a second speaker from the same company as long as there are more than two speakers per session. 2. A speaker should only speak once during the NBC or Annual Meeting. Workshops, Short Courses and Open Forums are considered separate events from the NBC or Annual Meeting. Organizers are encouraged to utilize speakers from Workshops, Short Courses or Open Forums at the NBC or Annual Meeting in order to save costs. In addition, FDA speakers may speak at more than one session. The ultimate goal is that the speaker should provide new content at each session. 3. Organizers should avoid using the same speaker for the same topic over a three year period. Speakers talking at sequential meetings should be speaking on different topics or at a minimum a very different aspect of a topic. Again, the repetition of a topic by the same speaker may lessen your chance of program acceptance. 4. Members may organize as many sessions as they want but should hand off additional sessions to other members to moderate. Moderators should only moderate one session per NBC or Annual Meeting. Co-moderators are encouraged to give more flexibility when cancellations occur. A co-moderator can cover when the other moderator cancels or potentially speak if a speaker cancels. The use of student co-moderators is highly encouraged to enhance the experience and training of our student members. 5. It is the expectation of AAPS that all speakers will provide their slides to post on the AAPS website following the NBC or Annual Meeting. Organizers and moderators should convey this to speakers at the time they invite speakers. Speakers will be requested to prepare slides that can be released to AAPS. Speakers may present one set of slides but provide AAPS a set to post on the website eliminating any slides with copyright issues. Page 75

76 How to Submit a Meeting Idea Annual Meeting and Exposition Session proposals are accepted for each annual meeting approximately one year in advance. For example, sessions for the 2013 annual meeting were submitted in December The annual meeting submission site opens every year in August and closes in early December. We encourage you to notify your section leadership about your proposals in order to gain support and possible collaboration with other sections and focus groups. National Biotechnology Conference (NBC) Session proposals are accepted for the NBC one year in advance. For example, sessions for the 2013 NBC were submitted during June The NBC submission site opens every year in April and closes in June. We encourage you to notify section leadership about your proposal in order to gain support and possible collaboration with other sections and focus groups. Other AAPS Meetings AAPS is now accepting proposals for workshops for 2013 and early All submissions will be reviewed for content, possible conflicts, and timing. The Program Coordination Committee (PCC) will review all proposals for Arden Conference as well as the workshops not being held in conjunction with the AAPS Annual Meeting and Exposition (AM) or the AAPS National Biotechnology Conference (NBC). Meetings being held in conjunction with those conferences will be reviewed by the respective programming committees, the Annual Meeting Programming Committee (AMPC) and the National Biotechnology Conference Programming Committee (NBCPC). Workshop Schedules Submission due to AAPS Staff Review Date Reviewing Committee Workshop Approvals for: July 8, 2014 August 6, 2014 PCC Arden Conference and Workshops to occur in March and April 2015 June 26, 2014 July 30, 2014 NBCPC NBC Workshops (up to 3) (June 2015) October 7, 2014 November 4, 2014 (at AM) PCC Workshops to occur in September 2015 AAPS is limiting the number of workshops to nine including those associated with the AM and NBC. This limit will allow the AAPS staff to manage all workshops in-house. Exceptions to this process will require explicit approval by the PCC. Not counted in the total number of workshops are requests for AAPS cosponsorships, in which our staff or financial involvement is minimal. Cosponsorships will be evaluated on an on-going basis. Send workshop suggestions on the completed form below to Elizabeth Scuderi at ScuderiE@aaps.org. Page 76

77 One Day Facility Hosted Seminars AAPS will begin offering one day seminars which will be hosted at pharmaceutical company facilities or on university campuses. Any member, focus group, or section wishing to hold a meeting of this type must complete the Facility Hosted Seminar Submission Form and submit that proposal to AAPS staff 6 9 months in advance of the meeting. AAPS staff will forward the proposal to the Program Coordination Committee for approval. Send facility hosted seminar suggestions via the completed form below to Sharon Pichon at PichonS@aaps.org. Facility Hosted Seminar Submission Form (DOC) Upcoming AAPS Meetings To assist you with planning new meetings, please be aware of scheduled AAPS meetings. For a list of upcoming AAPS meetings, please visit Sponsorship Solicitation Procedure AAPS, being a non-profit organization, encourages sponsorship of all activities. AAPS has developed several levels of sponsor categories and companies receive benefits based on the category level in which they participate. The most prestigious sponsor category is the AAPS Sustaining Sponsor. A primary benefit of a sustaining sponsor is the designation of an AAPS staff member as a primary point of contact for sponsorship activities. This is to facilitate sponsor benefits and eliminate duplicate or redundant requests for sponsorship throughout the organization. Therefore, it is critical to contact the Associate Director of Meetings and Expositions before engaging in any sponsorship solicitation. Volunteer members and staff dedicate much time to obtaining sponsors for various awards. To alleviate any concern on losing that sponsorship due to other sponsor solicitations throughout the year, sponsor solicitations must be coordinated through the AAPS Associate Director of Meetings and Expositions. FDA Sponsorship Policy 1. To avoid any conflicts of interest for FDA speakers, AAPS will not accept sponsor dollars for specific sessions which include an FDA speaker. 2. AAPS will continue to solicit sponsor and grant dollars for meetings as this is source of income for the organization. The sponsors will be recognized as a group in the printed programs and through other mechanisms as appropriate. 3. AAPS may solicit sponsor dollars and grants for the Keynote Address at the AAPS Annual Meeting & Exposition and other events, as long as the Keynote Speaker is not an FDA employee. Page 77

78 4. AAPS may solicit sponsor dollars and grants for the Plenary Session for the AAPS Annual Meeting & Exposition and the AAPS National Biotechnology Conference as long as the speakers are not FDA employees. Conclusions The American Association of Pharmaceutical Scientists will continue to provide the very best educational programming at workshops, seminars, conferences and special forums and will invite speakers from the Food and Drug Administration whenever appropriate. Sponsorships and grants, which are given to the Association to support such programs, will not be identified at the individual sessions where Food and Drug Administration employees are speaking. AAPS greatly values the intellectual contributions that the FDA provides to scientists within the pharmaceutical community. FDA Speaker Request Form The FDA requires the following form to be completed for every FDA speaker request. Please complete the form and return it to the AAPS Meetings Department, and we will submit the form to the FDA on your behalf. Please talk to the speaker before submitting the form. The FDA notifies AAPS of acceptance or refusal. AAPS will forward the FDA s response to the person who submitted the request. Page 78

79 AAPS MEETNGS FDA SPEAKER REQUEST FORM The Food and Drug Administration requires the following information to be completed by sponsoring organizations requesting FDA employees to attend, participate in, or speak at non-federal meetings, conferences, and symposiums. NAME OF SPONSOR ISSUING INVITATION: _American Association of Pharmaceutical Scientists SPONSOR TIN #: SPONSOR MISSION STATEMENT: PURPOSE OF CONFERENCE/MEETING: TARGET AUDIENCE: PURPOSE FOR WHICH THE FDA EMPLOYEE IS BEING INVITED: NAME OF FDA EMPLOYEE: NATURE OF COSTS TO BE REIMBURSED TO FDA (i.e., airfare, lodging, meals, miscellaneous expenses): If yes is answered to any of the questions below then acceptance of non-federal funding by the FDA is prohibited. Additional Certification: Yes No Is the traveler an officer, director, trustee, board member, partner or an employee of the sponsoring organization? Yes No Is the sponsor (or a component of this sponsoring organization) a party to a matter, which is pending before the FDA? Yes No Does the sponsor engage in any lobbying activities? Yes No Does the sponsoring organization receive any federal grants? Yes No Does the sponsoring organization receive any contracts with DHHS? Yes No Is the sponsoring organization a trade association? Yes No Is the sponsoring organization regulated in ay way by the FDA? Page 79

80 If yes is answered to any of the questions below then provide the additional information as required Yes No Is the sponsor a for-profit organization? If yes, then is the sole function of the organization to facilitate training/educational conferences/meetings? Yes No Does the sponsor include corporate funding? (e.g. foundations/memberships/donations)? If the answer to the question is yes, what percentage of the annual operating income is derived from corporate funding? % WE ALSO AGREE TO THE FOLLOWING: None of the funds that will be used to support these travel costs come from any federal grants or from any contracts with the Department of Health and Human Services, or from the regulated industry or trade associations. We further understand FDA's requirements that costs of employee travel accommodations may not be subsidized in any way, and assure that we will comply with that policy. Any room charges that are arranged for FDA employees by our organization will not be less than the hotel would normally charge to the traveling public, with the sole exception of volume discounts made available to us by the hotel. Our organization will not otherwise arrange for or make any additional payments to the hotel to defray room costs for FDA employees. Name: Please Print Title: Signature: Date: Page 80

81 elearning The mission of AAPS elearning is to innovate and manage electronic and universally accessible education opportunities for AAPS members and the scientific community. Biotechnology 101 AAPS is pleased to announce the release of a brand new online training course, AAPS Biotechnology 101. This comprehensive, multi-module course was developed for those interested in learning more about the field of biologic development and to fill training gaps. This series offers: Lectures by leading experts from industry and academia, Convenience of self-paced learning, Coverage of the current state of biotherapeutics, Practical perspectives from practicing scientists. This brand new training course was developed for: Professionals seeking to expand their knowledge to include biopharmaceuticals, College students and faculty members seeking to augment their training in biotechnology. ecourses An ecourse is an online, on demand, pre-recorded series of lectures around a particular topic. Discussion boards, quizzes, certificates of completion and e-commerce features are available for use in the course. Webinars AAPS webinars offer an opportunity for members to receive the latest information on pharmaceutical science topics without the need for travel or time away from home and office. AAPS members can participate in our upcoming live events, replay a past session in our archives, or submit a proposal online for organizing their own webinar. Webinars will be Accessible to AAPS Members Regular Members May Participate in the Live Event E-subscribers May View the Webinar 1 Month Later in the Archived Files Nonmembers May Become AAPS Members to Participate in the Live Webinar Webinars will Remain Free of Charge to all AAPS Members Page 81

82 Webinar Guidelines and Tips Webinars may be 60 or 90 minutes in length. Half of this period is devoted to the lecture, and the other half for the Q&A. There may be more than one presenter, but in a 90 minute event each presenter must share a 45 minute time period, or about 23 minutes each if there are two. This would leave the full 45 minutes for Q&A. Adequate Q&A time is quite important to the participants; it is the whole point of an interactive webinar. Be realistic about the published goals of the webinar. The most common participant criticism is that the description of the event did not correspond to the actual presentation. If the objective is to provide a brief, basic overview, please indicate so. During the registration process, some data may be collected beyond name and . To keep the registration process as simple as possible, please request only the data that you actually need and will evaluate. Also, we receive raw Excel data only, which must be tabulated manually. Approximately one-half to two-thirds of those who register for a webinar will actually show up. However, some attendees share the event with co-workers in a conference room. Thus, as a general rule of thumb, the total viewership is only slightly less than the number who originally registered. From experience we know that only one-third of participants will respond to a post-event survey. But we generally offer them the opportunity to submit free-form comments after the webinar. Webinars may be archived on the AAPS website for up to one year, with the author s permission. If you have a webinar idea, complete the form available online at The Executive Council is requesting that all sections develop a webinar. Focus groups may develop webinar ideas as well and we encourage you to work with your affiliated section(s) on the proposal. All proposals are sent to the AAPS Program Coordination Committee (PCC) for approval. After receiving approval, Andy Cohn, Senior Manager for e-learning, will work with the organizers and speakers to develop the webinar. To learn more, please contact Meredith Weston. Page 82

83 Volunteer Recruitment & Member Retention People may ask you why they should be a volunteer, or how to balance time spent at work with time dedicated to AAPS. If your job is to stay informed on the latest research, becoming an active volunteer within AAPS advances your education as a pharmaceutical scientist. Your employer should see the value in volunteering due to the received benefits such as networking, access to FDA guidances, research feedback, external ideas, educational offerings, and advertising for your company, to name a few. There are many different areas where volunteers can get involved: Abstract screening Awards Focus Groups Discussion Groups Programming: AAPS Annual Meeting, National Biotechnology Conference, workshops, themed meetings, and meeting clusters Student/PostDoc Outreach and Development (outreach/education) Publications: The AAPS Journal, AAPS PharmSciTech, Pharmaceutical Research, and more Strategic planning Web development Members leave because they are: 1. Not involved 2. Not aware 3. Excluded from decision making Making them feel welcome Valuing their contributions Retain New Members By... Giving them a meaningful job Using their skills & talents Involving them in decision making Page 83

84 Member Retention Tips Identify and recognize members with the most tenure. Do an online or survey of important questions and issues as they arise. Institute a thank you column in your section newsletter and website to recognize members for involvement and leadership. Keep experienced members active through targeted involvement. Suggest officers look for new members during section functions and spend some time with them. Increase meeting attendance by notifying members of membership meeting dates/times and provide an agenda in advance of the meeting. Be sure to welcome new members and ask for feedback. Page 84