Jun 2012 - DIA Global

June 24-28, 2012 | Philadelphia, PA | Pennsylvania Convention Center

2012Collaborate to Innovate

DIAP R O G R A M C O M M I T T E E R E S O U R C E G U I D E

June 2011

Dear DIA 2012 Annual Meeting Program Committee,

The DIA 2012 Annual Meeting Program Committee Resource Guide is provided to you as a reference to DIA’s policies

related to the development of sessions, speaker recruitment, and overall timeline schedule for the Annual Meeting

program.

The contents of this guide include 5 tabs that detail the following:

2012 Annual Meeting Program Committee Contact List Track Chair Responsibilities, DIA Policies and Procedures and DIA Volunteer Code of Conduct 2012 Annual Meeting Program Development Timeline, Component Document and Guideline Summary for

Program Participants

Continuing Education Summary and a helpful question and answer document describing the purpose of Disclosure Statements

DIA’s Policy Concerning Promotion of Products and Services from the Podium at DIA-Sponsored Programs

While this guide is not inclusive of all information related to the Annual Meeting, we hope that the information provided will

guide you as you communicate with your Chairs and Speakers that are involved in your Track.

Your support in the development of this program, ensuring the quality and standards of the Drug Information Association

are implemented are greatly appreciated.

We look forward to working with you in the coming months.

Sincerely

DIA 2012 Annual Meeting Team Mr. Craig Lipset

48th Annual Meeting Program Chairperson

Lori Risboskin Julie Ho

Director, Annual Meeting Manager, Annual Meeting Content Development

[email protected] [email protected]

215.442.6174 215.442.6179

Maureen Lamplugh Holly Stevens Laura Parker

Speaker Support Coordinator Speaker Support Coordinator Speaker Support Administrator

[email protected] [email protected] [email protected]

215.442.6115 215.442.6123 215-441.6101

mailto:[email protected]





Track prefix first_name last_name job_title company_name primary_phone primary_email_address SIAC1: Clinical Operations Dr Larry Blankstein Senior Director, Clinical

ResearchGenzyme Corporation

(617) 768-6635 [email protected] Global Sourcing; Biotechnology & Innovative Preclinical Sciences; Clinical Research

1: Clinical Operations Ms Kathleen Findlen Director, Clinical Operations Collegium Pharmaceuticals

(781) 704-4732 [email protected]

1: Clinical Operations Dr J. Michael Fitzmaurice Senior Science Advisor for Information Technology, Office of the Director

Agency for Healthcare Research and Quality (AHRQ)


1: Clinical Operations Mr Christopher Hoyle Executive Director Elite Research Network


2: Project/Portfolio Management and Strategic Planning

Dr Anne Cropp Executive Director Pfizer Inc (860) 732-6170 [email protected] GCP & QA; Professional Education and Training Development; Study Endpoints; Quality Risk Management


Ms Catherine Ohura Associate Director, Project Planning and Management

Bristol-Myers Squibb Company


2: Project/Portfolio Mr Gregg Schneider Director, R & D Financial Otsuka (609) 720-8473 [email protected]

DIA 2012 Annual Meeting Program Committee as of March 27, 2012

Please submit any changes to your contact information to [email protected]

jManagement and Strategic Planning

gg ,Management Pharmaceutical

( ) g gg @


Dr Leigh Shultz Project Leader Merck & Co., Inc. (732) 594-1117 [email protected] Project Management

3: Innovative Partnering Mr Solomon Babani Vice President, Outsourcing Celtic Therapeutics (212) 616-4085 [email protected]: Innovative Partnering Models & Outsourcing Strategies

Mr Charles Drucker Senior Director Covance (609) 452-4201 [email protected]

4: Nonclinical & Translational Development / Early Phase Clinical Development

Dr Paul Brown ODE Associate Director for Pharmacology and Toxicology, CDER

FDA (301) 796-0856 [email protected]


Dr Barry Mangum Director Clinical Pharmacology

Duke Clinical Research Institute

Mobile: 919.210.8099

[email protected]


Mr Cecil Nick FTOPRA, Vice President (Technical)

PAREXEL Consulting

44 7740 899230 [email protected]

5: Product Advertising & Marketing

Ms Janet L. "Lucy"

Rose President Lucy Rose and Associates, LLC

(703) 408-7066 [email protected] RA SIAC Good Promotional Practices Subgroup; RA SIAC Good Promotional Practices Subgroup Programming Subcommittee

6: Medical Writing & Medical Communications

Dr Natalie Gearhart Associate Director, Medical Communications

Ortho-McNeil Janssen Scientific Affairs LLC

(609) 730-3254 [email protected] MC SIAC Core Committee

mailto:[email protected]�

Track prefix first_name last_name job_title company_name primary_phone primary_email_address SIAC6: Medical Writing & Medical Communications

Ms Mary Stewart Divisional Director, Medical Documentation

H. Lundbeck A/S 45 36432465 [email protected] Medical Writing

6: Medical Writing & Medical Communications

Ms Janet Stoltenborg Director of Medical Communications

AstraZeneca Pharmaceuticals LP

(302) 886-7367 [email protected] MW SIAC Core Committee

7: Processes & Technologies for Clinical Research

Ms Nancie Celini Chief Learning Consultant CAB Inc. (914) 393-0244 [email protected] DM SIAC Best Practices & Education Subcommittee (Chair)


Ms Frances Nolan Vice President, Regulatory Compliance

Medidata Solutions Worldwide

(860) 439-1708 [email protected] Validation


Dr Stephen Raymond Chief Scientist, Quality Officer and Founder

PHT Corporation (617) 973-1610 [email protected] Study Endpoints


Mr Keith Wenzel Senior Director Perceptive Informatics

(941) 744-2348 [email protected] eClinical; Study Endpoints SIAC Core Committee

8: Regulatory Affairs & Submissions

Mr Roy Baranello Senior Director, Regulatory Affairs

ViroPharma Incorporated



Mrs Chin Koerner Executive Director, Regulatory Policy

Novartis Pharmaceuticals Corporation

(301) 468-5607 [email protected] IMPaCT SIAC Annual Mtg Subcommittee


Ms Kim Quaintance Senior Director, Regulatory Policy and Intelligence, Global RA CFU

Eisai, Inc. (207) 721-8428 [email protected] Regulatory Affairs


Mr Patrick Thomas Associate Director, Clinical Regulatory Affairs

GlaxoSmithKline (610) 787-3723 [email protected]

10: Public Policy/ Healthcare Compliance/ Regulatory Law

Dr Sandra Milligan Vice President, Global Regulatory Therapeutic Area Head, IVO

Genentech, Inc. (650) 467-3107 [email protected]

10: Public Policy/ Healthcare Compliance/ Regulatory Law

Ms Annetta Beauregard Vice President, US Regulatory Strategy

EMD Serono, Inc. (202) 626-2592 [email protected]

11: Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)

Dr Munish Mehra Managing Director Global Drug Development Experts

(240) 477-3700 [email protected] IT; CDM; Project Mgt; eClinical; Biotechnology & Innovative Preclinical Sci.; Clinical Research; GCP & QA; Statistics; Reg. Affairs; Validation; Prof. Educ. & Training Devel.; Document & Records Mgt; Elec. Reg. Submissions; Study Endpoints; Clinical Trial Disclosure.

11: Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)

Ms Shaghig Palanjian Senior Director, R&D Compliance

Shire HGT (781) 482-9460 [email protected]

12: Pharmaceutical Quality Dr Fritz Erni Consultant +41(79)3582112 [email protected]: Pharmaceutical Quality Dr Christine Moore Acting Deputy Director,

Office of New Drug Quality Assessment, CDER


12: Pharmaceutical Quality Dr Nirdosh Jagota Global Head of Small Molecules CMC and Regulatory Compliance

Genentech, Inc., A Member of the Roche Group


g y p p

Track prefix first_name last_name job_title company_name primary_phone primary_email_address SIAC13: Health Economics & Outcomes (HEO)/ Comparative Effectiveness Research (CER)/ Health Technology Assessment (HTA)

Dr Nancy Dreyer Senior Vice President, Scientific Affairs

Outcome (617) 715-6810 [email protected]

13: Health Economics & Outcomes (HEO)/ Comparative Effectiveness Research (CER)/ Health Technology Assessment (HTA)

Mr Christopher Marrone Senior Outcomes Liaison Eli Lilly and Company

(317) 433-2458 [email protected] EBM SIAC Core Committee; Medical Communications

14: Clinical Safety & Pharmacovigilance

Mr Alan Hochberg Integrated Safety Risk Manager

F.Hoffman-LaRoche Ltd.

+41 (61) 6872356 [email protected] Clinical Safety & Pharmacovigilance; ST SIAC Core Committee


Dr Jeffrey Litwin Executive Vice President and Chief Medical Officer

ERT (215) 972-0420 [email protected] Clinical Safety & Pharmacovigilance


Dr Margaret Richards Executive Director, Epidemiology and Health Outcomes

PPD, Inc (401) 245-2487 [email protected] Clinical Safety & Pharmacovigilance

15: Statistical Science & Quantitative Thinking

Dr Bruce Binkowitz Senior Director, Clinical Biostatistics

Merck Research Laboratories

(732) 594-4402 [email protected] ST Core Committee

15: Statistical Science & Quantitative Thinking

Dr Joan Buenconsejo Mathematical Statistician, Office of Translational Sciences, CDER

FDA (301) 796-1181 [email protected] ST Core Committee

16: Professional Development

Mrs Lauren Edelstein-Henry Principal Operational Specialist

Johnson & Johnson (610) 889-4543 [email protected]

16: Professional Development

Dr C. Latham Mitchell Managing Principal Erudita Biotechnical LLC

(850) 227-9590 [email protected] Medical Communications; Regulatory Affiars;Development LLC Regulatory Affiars; Professional Education and Training Development; Legal Affairs

Advisor-Asia Pacific Dr Ling Su Senior Vice President and Head of Development Greater China Region

Beijing Novartis Pharma Co., Ltd

86 2161606656 [email protected] CR SIAC Core Committee; CR SIAC Programming Subcommittee

Advisor-EMA Mr Martin Harvey-Allchurch Head of Communications European Medicines Agency, European Union

+44 (2074) 188699 [email protected]

Advisor-FDA Dr Leah Christl Associate Director for Biosimilars, Office of New Drugs, CDER


Advisor-Health Canada Dr Agnes Klein Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products

Health Canada (613) 954-5706 [email protected]

Advisor-Japan Dr Tatsuo Kurokawa Professor, Regulatory Sciences

Keio University Faculty of Pharmacy

81 354002495 [email protected]

Advisor- Patient Fellowship Dr Venitz Jürgen Associate Professor, Dept of Pharmaceutics, School of Pharmacy

Virginia Commonwealth University


Program Chair Mr Craig Lipset Head of Clinical Innovation, Worldwide Research and Development

Pfizer Inc (212) 733-9258 [email protected] eClinical; CR SIAC Core Committee; CR SIAC Programming Subcommittee; CR SIAC Oncology Working Group

Track prefix first_name last_name job_title company_name primary_phone primary_email_address SIACStudent and Professional Posters

Dr Barbara Gladson Director, Biopharma Educational Initiative; Professor

University of Medicine and Dentistry of New Jersey

(973) 972-2375 [email protected] Clinical Safety & Pharmacovigilance; Clinical Data Management; Professional Education and Training Development; Clinical Pharmacology

Student and Professional Posters

Dr James Parmentier Professor University of Medicine and Dentistry of NJ



Ms Carolynn Thomas-Jones Faculty Instructor, School of Nursing

University of Alabama at Birmingham

(205) 934-3863 [email protected] Professional Education, Training and Development SIAC


Dr Albert Wertheimer Professor of Pharmacy Administration, School of Pharmacy

Temple University (215) 707-1291 [email protected]




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2012 DIA Annual Meeting Track Chair Responsibilities

This document is in addition to the December 2004 DIA Board-approved Annual Meeting Policies and Procedures document. Responsibilities include: Attend all program development meetings and/or teleconferences to ensure consistency and non-overlap of

content within this track and offerings in other tracks. Be proactive in identifying the most important topic areas that best represent the Track’s interest area.

Track chairs will have the ability to identify key speakers to present on these topics as well as gain additional sources of content from the abstract submission process.

Review previous evaluation summaries and other sources of information toward the goal of improving the track. Maintain close working relationship with program participants and co Track chairs. Implement DIA’s policy on component structure and speaker recruitment. Ensure that chairs review presentations as needed after they have been submitted to the EP@C System to

confirm that each presentation: o Features the presenter’s company logo only once, on the first slide of his/her presentation. o Meets the content level criteria designated for the session. o Fits within the written overview. o Helps meet the learning objectives. o Is non-commercial, objective, fairly balanced and otherwise adheres to the “DIA Policy Concerning

Promotion of Products and Services from the Podium at DIA-Sponsored Programs.” (see page 2) o Does not overlap with others in the session; if it does, consider modifying whether overlapping

presentations to avoid this redundancy. Adhere to DIA Annual Meeting deadlines and assist DIA in ensuring that all program participants meet their

deadlines.

2012 Track Development

Hot Topics and Content GapsProgram Committee is proactive in identifying what hot topics

and content gaps are for the 2011 program

Track Vision*includes content scope/description

Recruited speakers as needed

Abstracts Submitted

Drug Information Association

Policies & Procedures

December 1997 Revised May 1998

Revised March 2000 Revised December 2004

Subject: DIA Annual Meeting Discussion: The DIA Annual Meeting is the Association’s worldwide premier event and is also the

North America annual meeting. Given the complexities of such an event, it requires a formal coordination process to ensure continued success. The Annual Meeting is under the aegis of the DIA Board of Directors.

Policy: The Annual Meeting will provide a neutral forum for presentation of information

consistent with the mission of DIA and provide opportunities for expert speakers to interact with attendees to provide value-added information to their professional knowledge base. The Annual Meeting is global in nature and leverages DIA’s unique position as a multi-disciplinary worldwide organization that allows exchange of information between diverse groups.

Roles and Responsibilities Director, North American (NA) Operations

The Director/Department of North America Operations shall be responsible for: • All pre- and onsite logistical matters associated with the annual meeting • All contractual negotiations/agreements in connection with the meeting: e.g. hotel, convention center contractors, vendors and suppliers; exhibition; sub-events • All issues related to communications and marketing plans; scheduling and assignment of sessions; site selection, coordination of sub-events; coordination and content of tutorials; obtaining final approval on selection of keynote speaker; supervision of interdepartmental annual meeting tasks; budget and financial reports, post meeting surveys and evaluation review; providing technology support to the committee, session chairs and speakers • Working with Program Chairperson and Program Committee to ensure that expectations are met in the areas of program quality, content and continuing education

Annual Meeting Chairperson

The Chairperson of the DIA Annual Meeting is approved by the Board of Directors. Chairpersons will be appointed three to five years before the assigned meeting. The DIA Executive Director will solicit names of potential Chairpersons from Board members, former Chairpersons and Office Staff members. The Executive Director will present a list of nominees to the DIA Executive Committee which will select final nominees and present these to the Board for approval at a full Board meeting. The Executive Director will notify those persons who have been approved by the Board.

Responsibilities of Current Chairperson

The current Chairperson is responsible for: • Recommending the Plenary Session keynote speaker to the Director, NA Operations. He/she shall be assisted by the Director, North American Operations in the selection process. A meaningful speaker should be selected for this session and consideration should be given to scientific, medical, political or motivational speakers. In keeping with DIA’s policy of neutrality, no speaker who would likely attempt to persuade the audience towards a particular political, religious or legislative agenda shall be chosen. • Final approval regarding session topics and scheduled time periods related to overlapping sessions • Ensuring that the Program Committee meets it responsibilities and expectations as outlined this policy • Providing a report (see Item #15 in the Expectations section) on the status of the Annual Meeting to the DIA Board of Directors at the December Board Meeting Annual Meeting Coordinating Committee A committee consisting of the current Annual Meeting Chairperson, the immediate past Chairperson, the next Annual Meeting Chairperson, and the Executive Director will be formed. This committee will assist the current Chairperson to meet the expectations noted below and will provide a method to train future Chairpersons. The immediate past Chairperson is expected to share lessons-learned. This committee also will review and approve the early draft list of Annual Meeting Tracks.

Program Committee

The Program Committee shall determine/recommend the learning objectives, themes/concepts, content and speakers for the event to the Director, North America Operations.

The Program Chair is responsible for recruiting additional committee members. A limited number of representatives shall serve on this committee and may be recruited from the membership at large. The Program Chair should strive to have balanced representation from academia, contract organizations, vendors, etc. The committee composition shall strive to have no more than one representative per company/organization. The term for a program committee member may not be more than 3 consecutive years. An individual may serve on the committee after a 2-year hiatus.

Each approved Track will have a lead chairperson. Where possible, each Track will include a team consisting of persons from Europe, Japan and the US. Tracks such as Regulatory, Clinical, IT, Project Management, GCP, Medical Writing, Clinical Safety, and Statistics should have global teams. In addition, each track chairperson shall assure that a member of a related SIAC, if it exists, has input to the track content, unless the track chairperson is a member of said SIAC.

The members of the Coordinating Committee, the Track Chairpersons and the additional persons assigned constitute the Annual Meeting Program Committee.

Ad Hoc Committees

The Program Chairperson may create ad-hoc committees to address specific needs of the meeting. Members of these committees are not subject to the term limitation of the program committee.

Expectations: The Annual Meeting Chairperson and the Program Committee are expected to:

1. Involve interested members in meeting planning and presentations 2. Review evaluations from past Annual Meetings and determine in changes in procedures or policies are necessary based on this feedback 3. “Reward” active participants in past meetings and in other DIA programs with opportunities for additional responsibility, e.g., Session Chairperson, Track Chairperson 4. Attempt to provide a focus on more than a single country in at least 50% of the sessions 5. Provide at least 20% of the sessions on FDA-related issues 6. Encourage innovative (new ideas) sessions, which may be limited in interest but which could provide unique opportunities for discussion of issues that might not be discussed at other industry meetings 7. Utilize the Annual Meeting as a testing ground for future workshop topics 8. Minimize the redundancies between session topics 9. Minimize concurrent sessions on similar topics 10. Maximize the number of volunteers who participate in the meeting (minimize the number of roles/times an individual participates with exception as noted in #11) 11. Encourage cooperation and sharing of resources/ speakers between tracks, especially for supported and government speakers 12. Encourage attendance and active participation of representatives of regulatory agencies (being certain to follow the established procedures) 13. Solicit input from the membership and/or Core Committees of appropriate SIACs on topics of interest for sessions and presentations. And request assistance from SIAC Core Committees in obtaining speakers as needed. 14. Support DIA’s Continuing Education program by offering programs that are fair balanced and free of commercial bias. 15. Provide a report on the status of the Annual Meeting to the DIA Board of Directors at the December Board Meeting. The report should focus on: -content of the program; validity and timeliness -how the program represents the membership -action plan for ensuring quality of the program -type and number of volunteer opportunities/activities -marketing strategy/plans -innovations/new ideas/improvement to program 16. Inform Track and Session Chairpersons that sessions are not to be promotional in nature. 17. Ask Track Chairpersons and the Director, North American Operations to evaluate session and speaker quality. They shall encourage all Session Chairs to actively seek session evaluations 18. Provide feedback to Session Chairperson and Speakers.

Annual Meeting Program Process

The DIA Director, North American Operations will provide each member of the Program Committee and each Session Chairperson a copy of this Policy & Procedures,

instructions for Track and Session Chairpersons, instructions for obtaining speakers from worldwide regulatory agencies, budgetary restraints (including limitations on the number and level of fully funded speakers, and their participation in multiple sessions), due dates and draft and approved copies of the Annual Meeting Grid (day by day, session by session schedule). The Director will interact directly with the Annual Meeting Chairperson, the other Coordinating Committee members, Track Chairpersons, Session Chairpersons, and speakers as needed.

Track Chairpersons shall review each abstract submitted to their assigned track. Within 1 week of receipt of these abstracts, the chairpersons shall review the receipts to determine is the author submitted the abstract to the correct track. Incorrectly classified abstracts shall be brought to the attention of the DIA Director, North American Operations who, in turn, shall forward the abstract to the more appropriate track chairperson. Track chairpersons shall then rank each submitted abstract before the due date according to the following scale: A: accept; important topic; B: potential or backup, accept if space available; C: reject.

In addition to the submitted abstracts, track chairpersons may submit topics for inclusion in the program that were not included in abstracts but which, in the opinion of the Track Chairperson, are important and should be in the program. After approval of these additional session topics by the Director, NA Operations or a member of the Coordinating Committee, each Track Chairperson, or additional assigned person, will select Session Chairpersons who are recognized experts in the session topic.

Session Chairpersons: Session Chairpersons shall select speakers for their respective sessions who are recognized experts in the session topics and who can present the topic well. They must get approval from the Director, NA Operations for all proposed supported speakers before they make any arrangements with such speakers. Session Chairpersons must not contact potential speakers from FDA, EMEA or the EU Commission. These agencies have specified that all requests for speakers from their respective agencies be made via the DIA. Additionally, the DIA regional offices should be notified regarding requests for speakers from other agencies. Session Chairpersons should refrain from selecting more than three speakers per 1-½ hour session. They also must adhere to the instructions given to them by the Director of North American Operations (see below).

Session Chairpersons must receive approval from the Director, North American Operations for all proposed supported speakers before they make any arrangements with such speakers. The requests to the Director, North American Operations must be made at the latest by April 1 of the year of the Annual Meeting. Requests received after this date may not be honored because of budgetary requirements. No more than 25% of the speakers at the Annual Meeting will be supported.

Meetings of The Committee: The Program Committee shall meet as determined by the Director, North America

Operations. The meetings may be face-to-face opportunities or teleconferences. They will serve to continually update the development of the program and measure the progress toward the completion of the program in accordance with the agreed timelines. DIA will facilitate these meetings.

DIA Volunteer Code of Conduct As constituents of a nonprofit, multidisciplinary, neutral forum for sharing information that optimizes the process of drug development and lifecycle management, volunteers should reflect the diversity in the global membership and should take into account regional representation, professional interest area, and work place setting. The spirit of this document attempts to uphold DIA’s Core Values of: passion for mission and vision; integrity; accountability and trust; treating people with respect and dignity; diversity; neutrality; and social responsibility. Volunteers shall at all times abide by and conform to the following Code of Conduct in their capacity as a DIA volunteer: General Expectations

1. Volunteers shall make decisions in the best interests of the organization. 2. Volunteers shall contribute to a collegial, inclusive, professional, positive, and respectful work

environment for fellow volunteers, stakeholders, and staff, and shall model the best in volunteer behavior.

3. Volunteers shall know, understand, and support DIA’s mission, vision, core values, purpose and goals and become familiar with and follow DIA policies, procedures, guidelines, and the Volunteer Code of Conduct while acting on behalf of DIA.

4. Volunteers shall not discriminate and shall be respectful of ethnic, national, and cultural differences.

5. Volunteers shall use DIA’s marks, insignia, name, logos, and trade dress (collectively, “DIA Marks”) in compliance with guidelines issued by DIA from time to time.

6. Volunteers shall at all times obey all applicable laws and regulations of the relevant government authorities, including all laws and provisions that govern appropriate conduct in the work place while acting on behalf of DIA.

Meetings and Communication

1. While acting on behalf of DIA, professional behavior and respectful discourse shall be required of volunteers. Disruptive or inappropriate behavior toward other volunteers, stakeholders or staff is unacceptable.

2. Only information deemed for public knowledge may be shared or discussed outside DIA, unless specifically authorized to do so by the Executive Director and/or the President. No volunteer shall share, copy, reproduce, transmit, divulge or otherwise disclose any confidential information related to the affairs of the Association, and each volunteer will uphold the strict confidentiality regarding any information discussed at meetings or any other deliberations and communications. Questions regarding the confidential nature of DIA information or documents shall be directed to the appropriate staff person or Board member.

3. Volunteers are not permitted to speak on behalf of DIA or the Board to external parties, such as the media or other interested parties unless specifically asked to do so by the Executive Director and/or the President.

4. All contractual agreements are the responsibility of the DIA office. Volunteers will not make such commitments on behalf of the DIA, except in accordance with established DIA policies.

5. All DIA correspondence, regardless of the medium, is a reflection on the Association. E-mail communications shall follow the same professional standards as verbal communication. E-mails may be considered legal documents and, therefore, caution shall be exercised when recording

written opinions and statements pertaining to the role of the volunteer in DIA. The use of the “blind copy” function is strongly discouraged when conducting official DIA business.

6. Volunteers shall support DIA to other volunteers, members, and stakeholders. Inappropriate communication by email or in any public forum about DIA, its volunteers, staff, stakeholders, policies, procedures or guidelines is not acceptable. Issues regarding DIA shall be taken up in private with the appropriate DIA staff member.

7. Participation in committee meetings (in-person and teleconferences) is typically required to fulfill a volunteer’s duties.

Relationship with Other Volunteers, Stakeholders and Staff

1. Volunteers shall understand the scope of their authority and exercise good judgment in their dealings with other volunteers, stakeholders, staff, suppliers and the general public and shall respond to all constituents and the needs of the Association’s members in a responsible, respectful and professional manner.

2. Volunteers shall not request special or personal favors or extensive information from other volunteers, stakeholders, or staff, without prior consultation and agreement of the Executive Director.

3. DIA events are professional gatherings and therefore appropriate behaviors are expected. Volunteers shall adhere to DIA policies, procedures, guidelines, and the Volunteer Code of Conduct in all interactions with other volunteers, stakeholders, staff, vendors, and other constituents.

Avoiding Conflict of Interest

1. No volunteer will use any information provided by the Association or acquired as a consequence of the volunteer’s service to the Association in any manner other than in furtherance of his or her volunteer duties. Furthermore, volunteers will not misuse Association property or resources and will at all times keep the Association’s property secure and not allow any person not authorized by DIA access to such property.

2. Volunteers shall not persuade or attempt to persuade any member, exhibitor, sponsor, supplier, contractor, or any other person or entity with an actual or potential relationship with the Association to terminate, curtail or not enter into its relationship to or with the Association, or in any way to reduce the monetary or other benefits to the Association of such relationship.

3. Volunteers are expected to act at all times in the best interest of the Association and not for personal or third-party gain or financial enrichment. When encountering potential conflict of interest, volunteers will identify the conflict and report it to the Director of Volunteer and Member Services / Chairperson of the Regional Advisory Committee who may ask them to remove themselves from all discussions and voting on the matter.

4. Volunteers will not accept gifts, gratuities, free trips, honoraria, personal property, or any other item of value from any person or entity as a direct or indirect inducement to provide special treatment to such donor with respect to matters pertaining to the Association without fully disclosing such items to the Director of Volunteer and Member Services in advance.

Confidential Communication Upon termination of service, volunteers will promptly return to the Association all documents, electronic and hard files, reference materials, and other property not already on file in the DIA office. Such return will not abrogate him or her from the continuing obligations of confidentiality with respect to the information acquired as a consequence of his or her tenure.

Violations of the Code of Conduct 1. DIA staff shall resolve any issues with volunteers in a professional manner. 2. Volunteers violating the Code of Conduct may be asked to resign their volunteer position and

may be requested to discontinue future volunteer roles. The Executive Director will determine if this action is necessary and will notify the volunteer.

3. Volunteers who have been removed from a volunteer position have 30 days to appeal the decision to the Executive Committee of the Board which will review the situation and respond within 30 days of the request for appeal. All decisions of the Executive Committee are final.

Volunteer Code of Conduct Revision – Board Approved March 22, 2009

DIA 2012 Annual MeetingProgram Development Schedule

as of June 4, 2011Deadline Task item

June 21, 2011 2012 Program Committee Meeting-Chicago, ILJune 30, 2011 Track Descriptions FinalizedWeek of July 18 DIA 2011 Annual Meeting Program Evaluations Available for ReviewAugust 1, 2011 Release of Announcement: Call for Proposal DetailsAugust 8, 2011 Opening of DIA 2012 Call for Proposal SubmissionsSeptember 12, 2011 COB deadline for DIA 2012 Call for ProposalsSeptember 13, 2011 Call for Professional Poster~ OPENSeptember 13, 2011 Call for Student Poster~ OPENOctober 17-18, 2011 Two day Planning Meeting, Philadelphia, PA Embassy Suites, Philadelphia AirportOctober 31, 2011 Deadline for all proposals to be rankedWeek of November 7, 2011 Acceptance NotificationsWeek of November 14, 2011 Decline NotificationsWeek of November 14, 2011 Webinar for Confirmed Chairs December 5, 2011 COB Deadline Submit speaker information to the Annual Meeting Speaker's Corner

January 9, 2012 Deadline for session details, speakers to make PRELIMINARY PROGRAM ANNOUNCEMENT

February 1, 2012 PRELIMINARY PROGRAM to print

February 16, 2012 Deadline for Call for Professional Posters

March 1, 2012 Final requests for FDA participants to DIA

March 5, 2012 Deadline for Student Call for Posters

April (month of) Speaker webinars available for viewingApril (late) The official 2012 DIA Annual Meeting PowerPoint Template will be available!April 26, 2012 Completion of ONSITE FINAL PROGRAM

June 7, 2012 1st upload of presentation for attendee pre availability opportunity

June 14, 2012 FINAL upload of PowerPoint presentations to be submitted to EP@C system

June 18-22, 2012 Chairs to review all submitted presentations and conduct follow up calls or emails to speakers who have not submitted their presentation for review.

June 24-28, 2012DIA 2012 Annual Meeting

Pennsylvania Convention Center1101 Arch StreetPhiladelphia, PA

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Guideline Summary

DIA 2012 Annual Meeting June 24-28, 2012 Philadelphia, PA

NOTE: As of June 6, 2011, policies have been changed to reflect new opportunities for the DIA 2012 Annual Meeting Program. We strongly encourage all participants, veteran and new, to review the below policies in order to be compliant with the program development process as well as standard DIA policies.

REQUIREMENTS FOR PROGRAM PARTICIPANTS OF THE ANNUAL MEETING PROGRAM AUDIO-VISUAL RECORDING/PARTICIPANT DISCLOSURES

Confirmed participants in the Annual Meeting program are required to complete a disclosure and audio-visual consent form. All components will be recorded and made available to DIA Annual Meeting attendees through the DIA Live Learning Center. All participants must also disclose any significant financial relationship with the manufacturer(s) of any commercial product(s) and/or providers of commercial services discussed in an educational presentation, as well as any discussion of unlabeled or unapproved uses drugs or devices. An audio visual and speaker disclosure form must be completed by all component participants in order to participate in the program. In support of the Accreditation Council for Pharmacy Education (ACPE) guidelines, DIA has implemented a policy where anyone in a position to control the content of an educational activity must disclose all relevant financial relationships with any commercial interest. Should a conflict of interest exist as a result of the financial relationship, this must be resolved prior to the activity. Individuals who do not complete the AV consent and disclosure form will be ineligible to participate as a faculty member for this program.

GENERAL GUIDELINES

Below are general guidelines to be followed within each component offering. Please refer to page 2 regarding component structures.

Co-chairs or co-presenters for presentations are not permitted.

More than one participant from the same company in component is not permitted. No exceptions will be made.

Chairperson must ensure good representation/diversity in the selection of speakers/panelists. If applicable, government, academia, CSO, and/or industry perspectives should be represented.

No internet connectivity is available in the session room.

Each component format is limited to one supported participant (see Speaker Support below).

The meeting registration is waived, and DIA will register confirmed participants. Note: Preconference tutorials and the DIA and Tufts Center for the Study of Drug Development Executive Program require separate registration and payment.

Program participants are responsible for their own travel/hotel expenses (unless they qualify for support – see Speaker Support below).

DIA meetings will be educational, not commercial and promotional. All speakers must ensure that their presentation is not of a commercial or promotional nature, and that logos and company information are only included on the first page of the PowerPoint presentation and printed materials. In addition, speaker clothing may not carry logs or other company-specific emblems. All participants must follow the DIA Policy Concerning Promotion of Products and Services from the Podium.

SPEAKER SUPPORT:

Each component is limited to one supported participant. Supported speakers include full-time government/ regulatory employees, full-time academic, whose only source of income is from an academic institution and/or not-for-profit employees. All requests for support must be sent to the US DIA office for approval before chairs/speakers/panelists are invited and before the Preliminary Program is developed.

Supported speakers will receive roundtrip coach/economy airfare (arranged through the DIA travel agent), plus 2 nights’ hotel room and tax, and per diem of up to $50 per day for no more than 3 days to cover food and miscellaneous expenses.

Local transportation and airport parking costs will be covered outside of the per diem if the amount is significant. Receipts must be submitted at time of reimbursement.

http://www.diahome.org/DIAHOME/GetInvolved/Resources/Docs/DIAPodiumPolicy.pdf

http://www.diahome.org/

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REGULATORY AGENCY SPEAKERS:

Individuals from the following regulatory organizations may not be contacted directly to participate: FDA, EMA, EU, MHRA, SFDA and Health Canada. Per regulatory agency policy, DIA is to officially request the participation of speakers from these organizations. The chair is to provide DIA with the requested speaker’s name and topic to be presented as early as possible to ensure the best opportunity for receiving approval from the respective agency. Speakers from other organizations may be contacted directly by the component chair.

AT A GLANCE: GUIDELINES FOR ANNUAL MEETING PROGRAM COMPONENTS

Program Guidelines

Session / Symposium

Workshop

Forum

Professional Poster

Student Poster

Length

60 or 90 minutes

90 minutes 60 or 90 minutes

120 minutes One day

Chairperson

Abstract Author

or Designee

Abstract Author

or Designee

Abstract Author

or Designee

No No

Co-chair / co-presenter permitted

No No No No No

Maximum number of participants

4 3 4 N/A N/A

PowerPoint required

Yes See guidelines No N/A N/A

More than one participant from same company/organization permitted

No No No N/A N/A

Number of permitted participants who require support (see SPEAKER SUPPORT)

1 1 1 N/A N/A

Session to be recorded

Yes No Yes No No

Internet connectivity available

No No No No No

COMPONENT FORMAT POLICIES Session / Symposium Guidelines:

A 60 or 90-minute session delivered lecture-style from the podium.

Session chair will coordinate efforts in recruiting speakers, adhere to DIA guidelines, and manage the session (including the facilitation of question and answers from the audience) at the Annual Meeting.

No more than 3 speakers may be invited. The session chair may be one of the speakers. When selecting speakers, please note that it is DIA’s goal to have 50% of the sessions globally oriented. Refer to general guidelines on page 1.

Microsoft Office PowerPoint for Windows presentations are required from each speaker.

No internet connectivity is available in the room. Workshop Guidelines:

A 90-minute conceptual workshop delivered in an interactive/simulation or role-playing format.

Workshop chair must adhere to DIA guidelines, and manage the workshop at the Annual Meeting.

Onsite learning in the form of activities or demonstrations is required.

No more than 2 facilitators who must be involved in the workshop can be included (not to exceed 3 total participants).

No internet connectivity is available in the room. Forum Guidelines:

A 60 or 90-minute forum delivered as a blend of presentation and panel discussion.

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Forum chair will coordinate efforts in recruiting panel members, adhere to DIA guidelines, moderate the forum (including the facilitation of questions and answers from the audience) at the Annual Meeting.

No more than 3 panelists may be invited. The forum chair may be one of the panelists. When selecting panelists, please note that it is DIA’s goal to have 50% of the sessions globally oriented. Refer to general guidelines.

PowerPoint presentations are NOT required by panelists.

No internet connectivity is available in the room. Professional Poster

A scientific abstract delivered through a visual format (4’ × 8’ poster) in an informal, interactive presentation. Professional poster sessions (which include 50 other postings) are 120 minutes in length and are in a public area where attendees may walk through and view the posters.

The submitting author is the designated presenter listed in all DIA announcements and must pay a registration fee to attend the Annual Meeting. Co-authors may participate but must pay a registration fee to attend.

See Professional Poster Resource Guide for more details.

No internet connectivity is available. Student Poster

A scientific abstract delivered through a visual format (4’ × 8’ poster) in an informal, interactive presentation. The student poster session is scheduled for Monday, June 25, 2012, and will take place in a public area where attendees may walk through and view the posters.

The submitting author is the designated presenter listed in all DIA announcements.

See Student Poster Resource Guide for more details.

No internet connectivity is available.

Continuing Education Guidelines for the Annual Meeting

All presentations are to be fair balanced and free of commercial bias.

All sessions must have at least two (2) learning objectives that clearly indicate what participants will be able to do after attending the session.

Anyone in a position to control content (this includes program chairperson

and committee members, track chairs, session chairs, speakers, and panelists) must provide DIA with any significant financial relationships they have with the manufacturer of products or services as discussed within their presentation or with regard to the content of the session/meeting (for those who are not speaking).*

If a program participant (as noted above) has a conflict of interest as a result of the financial relationship, this will need to be resolved prior to the meeting.

If a program participant does not provide disclosure to DIA, he/she will not

be permitted to participate in the meeting.

When discussing therapeutic options, it is DIA’s preference that only generic names and not trade names be used. If it is necessary to use trade names, please use the trade names of all products being discussed.

All recommendations involving clinical medicine in a CME session must be

based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients.

* Please see attached Disclosure Question and Answer document.

Disclosure Questions and Answers DIA is accredited by the Accreditation Council for Pharmacy Education (ACPE), the Project Management Institute (PMI) and the International Association for Continuing Education and Training (IACET). Frequently asked questions regarding participant disclosure and responses are noted below.

Why do volunteers need to disclose? As an accredited provider, DIA is required to provide its activity participants with the financial relationships of anyone in a position to control the content of a continuing education activity.

Who needs to disclose? Anyone in a position to control content: Program chairperson(s) Track chairs Session chairs Speakers Panelists Authors DIA managers and planners of continuing education activities (The above are referred to in this document as program participants)

What needs to be disclosed? All relevant financial relationships with the commercial supporter (if applicable) or manufacturer of products and/or services discussed within the activity and/or presentation. Program chairpersons and track chairs need to provide disclosure related to the development of the activity; session chairs, speakers, and authors need to provide disclosure related to the content of their presentation.

If a program participant has no financial relationships that also needs to be disclosed.

Does a program participant need to disclose all financial relationships? No, only financial relationships within the last 12 months that pertain to the content of the educational activity or presentation.

Does a program participant need to disclose the amount of the financial relationship? No.

If a volunteer participates as a program participant in multiple activities, does he/she have to complete a disclosure form for each activity? Yes. The disclosure is pertinent to the content/presentation of the given activity.

Do the updated Accreditation Council for Continuing Education (ACCME) Standards for Commercial Support (SCS) affect all DIA activities? The policies and procedure established to support the new ACCME SCS only apply to continuing medical and pharmacy education activities.

How do the updated SCS impact DIA’s CE program? All program participants must provide disclosure in order to participate in the educational activity. If a program participant has a conflict of interest, the conflict must be addressed prior to the educational activity. If resolution cannot be made, CME and/or pharmacy credit may not be offered for the activity.

DIA Policy Concerning Promotion of Products and Services

From the Podium at DIA-Sponsored Programs

The Drug Information Association encourages and supports the exchange and dissemination of information pertaining to research and development of health care products, regulatory processes, emerging technologies, and information management. The Association does this by providing its members a neutral forum for education and discussion opportunities concerning the latest technologies and processes. Preservation of the neutrality of this forum, fostering collaborative efforts among academia, contract houses, contract research organizations, health regulatory authorities, industry, practitioners, and vendors, is essential to the success of DIA. The Association draws a clear distinction between the dissemination of information and outright commercial promotion of a consultant, commercial product, research institution, or service. At DIA-sponsored programs, presentations by persons affiliated with commercial organizations or educational institutions that provide services or products must be limited to scientific, technical or process issues. Presentations should not overtly endorse or recommend a specific product or service. The theme and content of slides, overheads, handouts and other presentation aids should not promote a commercial product or service. This also applies to the use of company logos, which may only appear on the first slide of a slide presentation. In addition, speaker clothing may not carry logos or other company specific emblems. In this way, DIA meetings will be educational, rather than commercial and promotional. The DIA Office will create and disseminate publicity pertinent to a DIA meeting, workshop, training course, tutorial, or any other DIA-sponsored activity. All such publicity will be distributed directly from the DIA Office. Individuals and organizations can, at their option, make tasteful announcements of their participation in DIA-sponsored meetings, but should refrain from doing so until confirmation of participation has been received from the DIA Office. Any advertising of participation in a DIA-sponsored meeting by an individual or an organization shall not use any copyrighted material from DIA or the DIA trademark. The DIA Board of Directors encourages the membership to provide feedback to the DIA Executive Director regarding violations of this policy. The Executive Director will address such violations directly with those involved. Remedies may include restriction on future participation at DIA events.

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Jun 2012 - DIA Global

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