DIA 2011 · 1: Clinical Operations Shantal Feltham Stiris Research Inc. (519) 471-6211 X118...

DIA 2011Convergence of Science, Medicine, and Health

47th Annual MeetingJune 19-23, 2011

Chicago, IL | McCormick Place

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PROGRAM COMMITTEE RESOURCE GUIDE

June 2010 Dear 2011 Annual Meeting Program Committee Member, The 2011 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:

2011 Annual Meeting Program Committee Contact List Track Chair Responsibilities, DIA Policies and Procedures and DIA Volunteer Code of Conduct 2011 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

The 2011 DIA Annual Meeting Team Mr. Kenneth Getz 47th Annual Meeting Program Chairperson Holly Stevens Maureen Lamplugh

Speaker Support Speaker Support [email protected] [email protected] 215.442.6123 215.442.6115 Lori Risboskin Julie Ho

Director, Annual Meeting Manager, Annual Meeting Content Development [email protected] [email protected] 215.442.6174 215.442.6179

mailto:[email protected]




ROLE FIRST LAST PRE COMPANY NAME PHONE EMAILProgram Chair Ken Getz MR Tufts University; CISCRP (617)636-3487 [email protected]/Pacific Ling Su DR Novartis Pharmaceuticals Corporation (86) 13764304386 [email protected] Agnes Klein DR Health Canada (613) 954-5706 [email protected] Martin Harvey-Allchurch MR European Medicines Agency, European Union 44 (2074) 188699 [email protected] Kim Quaintance MS FDA (301) 796-0140 [email protected] Topics Stephen Wilson DR FDA (301) 796-0579 [email protected] Tatsuo Kurokawa DR Chiba University (81) 337187515 [email protected] FIRST LAST PRE COMPANY NAME PHONE EMAIL1: Clinical Operations Deirdre BeVard MS Endo Pharmaceuticals (240)405-5780 [email protected]: Clinical Operations Shantal Feltham Stiris Research Inc. (519) 471-6211 X118 [email protected]: Clinical Operations J. Michael Fitzmaurice DR Agency for Healthcare Research and Quality (301) 427-1227 [email protected]: Clinical Operations Christopher Hoyle MR Elite Research Network (843)849-7382 [email protected]: Clinical Operations Ellen Kelso MS Goodwyn IRB (513) 793-8900 x114 [email protected]: Clinical Operations Ross Pettit MR AMAG Pharmaceuticals, Inc. (617) 498-2870 [email protected]: Development Planning Anne Cropp DR Pfizer Inc (860) 732-6170 [email protected]: Development Planning Catherine Ohura MS Kyowa Hakko Kirin Pharma Inc. (609)919-1100 [email protected]: Development Planning Gregg Schneider MR Otsuka Pharmaceutical (330)484-2695 [email protected]: Development Planning Raymond Starrett MR Targacept Inc. (336) 480-2122 [email protected] O t i St t i & I ti P t i S l B b i MR C lti Ph D l t S i (212) 616 4085 l b b i@d lti h

2011 ANNUAL MEETING PROGRAM COMMITTEE as of 08/30/2010Please submit any changes to your contact information to

[email protected]

3: Outsourcing Strategies & Innovative Partnering Models

Solomon Babani MR Celtic Pharma Development Services (212) 616-4085 [email protected]


Chuck Drucker MR Covance Inc. (609)452-4201 [email protected]


Patricia Leuchten MS The Avoca Group Inc. (609) 252-9020 [email protected]

4: Non Clinical & Early Clinical Translational Development

Paul Brown DR FDA (301) 796-0856 [email protected]


Cecil Nick MR PAREXEL Consulting 44 (7740) 899230 [email protected]


Frank Sistare DR Merck & Co., Inc. (215) 652-0043 [email protected]


Howard Uderman DR Pfizer Inc (203) 401-0238 [email protected]

5: Product Advertising & Communications Wayne Pines MR APCO Worldwide Inc. (202) 256-5455 [email protected]: Medical Writing & Communication Stacey Fung DR Genentech, Inc. (650) 467-0416 [email protected]: Medical Writing & Communication Mary Stewart MS H. Lundbeck A/S (45)3643 2465 [email protected]: Medical Writing & Communication Janet Stoltenborg MRS AstraZeneca Pharmaceuticals LP (302) 886-7367 [email protected]: IT Methods & Technologies for Life Science Research

Frances Nolan MS Medidata Solutions Worldwide (860) 439-1708 [email protected]

7: IT Methods & Technologies for Life Science Research

Thomas Quinn MR The Hollis Group Inc. (610) 889-7350 [email protected]

7: IT Methods & Technologies for Life Science Research

Stephen Raymond DR PHT Corporation (617) 973-1610 [email protected]

2011 ANNUAL MEETING PROGRAM COMMITTEE as of 08/30/2010Please submit any changes to your contact information to

[email protected]

Annual Mtg/Mtg Docs/Planning/Pre-Planning/General






TRACK FIRST LAST PRE COMPANY NAME PHONE EMAIL7: IT Methods & Technologies for Life Science Research

Greg Saltzman MR Fisher BioPharma Services (610) 849-0301 [email protected]

8: Life Science Research Informatics & Content Management

Teresa Ancukiewicz MS Boston Scientific Corporation (508) 683-4516 [email protected]


Nancie Celini MS CAB Inc. (914) 393-0244 [email protected]


Keith Wenzel MR Perceptive Informatics (941) 744-2348 [email protected]

9: Regulatory Affairs & Sciences, Quality & GXP Compliance

John Aitken DR Gilead Sciences (650) 522-1929 [email protected]


Roy Baranello MR ViroPharma Incorporated (610) 321-2317 [email protected]


Fritz Erni DR Consultant 41(79)3582112 [email protected]


Chin Koerner MRS Novartis Pharmaceuticals Corporation (301) 468-5607 [email protected]


Elaine Morefield DR FDA (301) 796-1987 [email protected]


Joseph Scheeren DR Bayer HealthCare Pharmaceuticals, Inc. (973)487-2525 [email protected]


Bruce Wagman MR Covance Inc. (609) 452-4051 [email protected]

10: Public Policy/Health Care Compliance Howard Dorfman MR Ropes & Gray (212)596-9000 [email protected]: Public Policy/Health Care Compliance Sandra Milligan DR Amgen Inc. (805) 447-7585 [email protected]: Clinical Safety & Pharmacovigilance Carol Krueger MS FDA (301)796-3241 [email protected] g g ( ) g @ g11: Clinical Safety & Pharmacovigilance Jeff Litwin DR ERT (215)972-0420 [email protected]: Clinical Safety & Pharmacovigilance Margaret Richards DR PPD, Inc. (401) 245-2487 [email protected]: Statistics Bruce Binkowitz DR Merck & Co., Inc. (732) 594-4402 [email protected]: Statistics Joan Buenconsejo DR FDA (301)796-1181 [email protected]: Health Economics & Outcomes / Comparative Effectiveness Research

Matthew Rousculp DR MedImmune (301) 398-5984 [email protected]

13: Health Economics & Outcomes / Comparative Effectiveness Research

David Sykes MR PRMA Consulting 44(0) 1252 279503 [email protected]

14: Medical Devices tbd tbd15: Professional Development Carol Mitchell DR Eli Lilly and Company (317) 277-8976 [email protected]: Professional Development Theresa Hummel-Krallinger MS Almac Group (267) 685-4284 Theresa.Hummel-

[email protected] and Student Poster Co-chairs COMPANY NAME PHONE EMAIL

Poster co-chair Kris Walters DR University of North Carolina Wilmington (910) 962-3640 [email protected] co-chair Barbara Gladson DR University of Medicine and Dentistry of NJ (973) 972-2375 [email protected] Annual Meeting Team PHONE EMAILProgram Director Lori Risboskin (215) 442-6174 [email protected], Content Development Julie Ho (215) 442-6179 [email protected] Development and Speaker Support Associate

Holly Stevens (215) 442-6123 [email protected]

Program Development and Speaker Support Associate

Maureen Lamplugh (215) 442-6115 [email protected]

MSMSMS

Annual Mtg/Mtg Docs/Planning/Pre-Planning/General










2011 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. New for the 2011 Program:

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.” 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.

2011 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

47th DIA Annual Meeting

Program Development Schedule

as of June 2, 2010Deadline Task item

June 1, 2010 All hands call 2011 Program Committee Kick off Call

June 16, 2010

2011 Program Committee Meeting-Washington, DC (working luncheon)

*Individual track descriptions finalized

*Draft of hot topics by track and invited speakers to present on the topic

June 30, 2010 Track descriptions finalized

July 12, 2010

*Outline of Topics by Track and key individuals to invite

*Component wish list by Track due

July 12, 2010 2011 Call For Abstracts-Details published and available on the DIA website

July 19, 2010

Announcement to SIACs regarding one session per SIAC proposal due to DIA by September

13. Submission process to be announced

August 10, 2010 Call for 2011 Abstracts Open for Submissions

September 13, 2010 Close of 2011 Call for Abstract Submissions

October 4-5, 2010 Program Committee Meeting, Embassy Suites, Philadelphia Airport, Philadelphia, PA

October 18, 2010 Deadline for all abstracts to be ranked

November 1, 2010 (week of) Accepted abstract notification

November 15, 2010Declined abstract notification

December 20, 2010Names of speakers and presentation titles to DIA, including FDA participant requests

(provide detail to DIA by this deadline and book your hotel room prior

to the room block opening to the public)

January 10, 2011Deadline for session details, speakers to make

PRELIMINARY PROGRAM ANNOUNCEMENT

February 1, 2011 PRELIMINARY PROGRAM to print

March 1, 2011 Final requests for FDA participants to DIA

April (month of) Speaker webinars available for viewing

April (late) The official 2011 DIA Annual Meeting PowerPoint Template will be available!

April 26, 2011 Completion of ONSITE FINAL PROGRAM

June 8, 20111st upload of presentation for attendee pre availability opportunity

June 13, 2011 FINAL upload of PowerPoint presentations to be submitted to EP@C system

June 13-17, 2011Session chairs to review all submitted presentations and conduct follow up calls or

emails to speakers who have not submitted their presentation for review.

June 19-23, 2011

2011 DIA Annual Meeting

McCormick Place

2301 South Lake Shore Drive

Chicago, Illinois 60616

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Guideline Summary

47th DIA Annual Meeting June 19-23, 2011

Chicago, IL 2011 PROGRAM SCHEDULE:

Each concurrent component will last for 90 minutes. SIAC Showcase is 60 minutes. There will be 30-minute refreshment break between sessions and a 90-minute luncheon break Monday and Wednesday. Tuesday’s luncheon will begin at 11:30 and end at 2:00pm.

Monday, June 20 – Plenary session at 8:30am and concurrent components at 10:30am, 1:30pm and 3:30pm.

Tuesday, June 21 – Plenary session at 8:00-9:30am and concurrent components at 8:00am, 10:00am, 2:00pm. SIAC Showcase at 4:00-5:00pm

Wednesday, June 22 – Plenary session at 8:00-9:30am and concurrent components at 8:00am, 10:00am, 1:30pm and 3:30pm.

Thursday, June 23 – Components at 9:00am and 10:45am.

NOTE: As of May 2010, policies have been changed to reflect new opportunities for the 2011 DIA 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 3 regarding component structure.

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.

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

The meeting registration fee is waived for the permitted number of individuals within a component, including the chairperson. DIA will register confirmed participants. NOTE: Tours, tutorials and the networking reception 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.

http://www.diahome.org/productfiles/23753/DIA%20Policy%20on%20Promotion%20of%20Products%20and%20Services%20from%20the%20Podium.pdf

http://www.diahome.org/

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SPEAKER SUPPORT:

Each component is limited to one supported participant. Supported speakers include full-time government/ regulatory employees, full-time academic 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.

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.

HOUSING: Please note that Travel Planners is the exclusive housing provider of the 47th DIA Annual Meeting. Third party providers may contact speakers and exhibitors to book their hotel reservations. These providers may require reservations be fully prepaid, are non-refundable and may be subject to steep cancellation and change fees. Should you choose to book with any provider other than Travel Planners, DIA will not have the ability to assist with any issues one may have with the terms of their agreement.

AT A GLANCE: GUIDELINES FOR ANNUAL MEETING PROGRAM COMPONENTS

Program Guidelines

Session

Workshop

Forum

Executive

SIAC Showcase

Professional Poster

Student Poster

Session Length

90 minutes 90 minutes 90 minutes 90 minutes 60 minutes 120 minutes One day

Chairperson

Abstract author

Abstract author

Abstract author

To be determined

Abstract author

No No

Co-chair / co-presenter permitted

No No No No No No No

Maximum number of participants

4 3 4 4 3 N/A N/A

PowerPoint required

Yes See guidelines

No No See guidelines

N/A N/A

More than one participant from same company/organization permitted

No No No No No N/A N/A

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

1 1 1 1 1 N/A N/A

Session to be recorded

Yes Yes Yes Yes Yes No No

COMPONENT FORMAT POLICIES

Session Guidelines:

A 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.

PowerPoint presentations are required from each speaker. 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.

P a g e | 3

Forum Guidelines:

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

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. Executive Session Guidelines:

A 90-minute high level session that blends presentation and panel discussions

Executive Session chair will coordinate efforts in recruiting panelists, 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 panelists may be invited. The chair may be one of the speakers/panelists.

PowerPoint presentations are NOT required by panelists. SIAC Community Showcase Guidelines:

A 60-minutes showcase o Content can be delivered in the following ways:

A session, where recruited speakers deliver the content via a PowerPoint presentation(s) and time for audience questions & answers, OR

A forum, where recruited speakers can deliver content in the form of a panel discussion and no PowerPoints will be used.

Showcase chair will coordinate Showcase, adhere to DIA guidelines, and manage the showcase including the facilitation of questions and answers from the audience at the Annual Meeting.

No more than 3 individuals (this includes the Showcase chairperson and 2 speakers/panelists)

When selecting speakers/panelists, please note that it is DIA’s goal to have 50% of the sessions globally oriented. 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. Student Poster

A scientific abstract delivered through a visual format (4’ × 8’ poster) in an informal, interactive presentation. The Student poster session is scheduled on Monday, June 20, 2010, 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.

2011 DIA Annual Meeting Program ScheduleFor Program Committee Use ONLY

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16 13 3 170 54 24 29 100 1 1 25 10 16 462Sunday

8:30‐12:00pm 8 8 161:00‐4:30pm 8 89:00‐5:00pm 5 5

3:00pm‐5:00pm 1 1Total 16 13 1 30

Monday 08:30‐10:00am 1 1

10:30am‐12:00pm 16 5 2 3 1 271:30‐3:00pm 16 5 2 3 1 273:30‐5:00pm 16 5 2 3 1 279:00‐6:00pm 1

Total 1 48 15 6 9 1 3 82Tuesday

8:00‐9:30am 1 8 3 2 1 1410:00am‐11:30am 16 5 2 3 1 272:00pm‐3:30pm 16 5 2 3 1 274:00‐5:00pm 2512:00‐2:00pm 505:00‐6:00pm 8 8

Total 1 40 13 6 6 50 25 3 8 76Wednesday8:00‐9:30am 1 8 3 2 1 15

10:00am‐11:30am 16 5 2 3 1 271:30pm‐3:00pm 16 5 2 3 1 273:30‐5:00pm 16 5 2 3 1 275:00‐6:00pm 8 812:00‐2:00pm 50

Total 1 56 18 8 9 50 4 8 104Thursday

9:00‐10:30am 16 5 2 3 2610:45‐12:15pm 10 3 2 2 17

Total 0 26 8 4 5 43

Highlights:

Monday, Tuesday, Wed first session =PLENARYThursday begins at 9:00am and ends at 12:15pm

Professional Posters 2 hrs on Tues and Weds Exhibitor Showcase Tues/Wed 5:00‐6:00pmTuesday and Wednesday start 8:00am

©2010 Brad Yeo c/o theispot.com


47th Annual Meeting

June 19-23, 2011Chicago, IL McCormick Place

Call for Proposals Opens: August 10, 2010Deadline: September 13, 2010 Close of Business

Program Chairperson . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Annual Meeting Attendee Demographics . . . . . . . . . . . . . . . . . . . . . 4

2011 Annual Meeting Tracks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Types of Proposals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2011 Track Topics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Track 1: Clinical Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Track 2: Development Planning and Management . . . . . . . . . . . 7

Track 3: Outsourcing Strategies and Innovative Partnering Models . . . . . . . . . . . . . . . . . . . . . 7

Track 4: Nonclinical Operations and Early Clinical Translational Development . . . . . . . . . . . . . . . . . . . . . . . . 8

Track 5: Product Advertising and Communications . . . . . . . . . . 8

Track 6: Medical Writing and Communications . . . . . . . . . . . . . . 8

Track 7: IT Methods and Technologies for Life Science Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Track 8: Life Science Research Informatics and Content Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Track 9: Regulatory Affairs and Science, Quality and GxP Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10

Track 10: Public Policy/Health Care Compliance . . . . . . . . . . . . 10

Track 11: Clinical Safety and Pharmacovigilance . . . . . . . . . . . . . . 11

Track 12: Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Track 13: Health Economics and Outcomes (HEO) Comparative Effectiveness Research (CER) . . . . . . . . 12

Track 14: Medical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Track 15: Professional Development . . . . . . . . . . . . . . . . . . . . . . . 12

Helpful Hints for Submitting Abstracts . . . . . . . . . . . . . . . . . . . . . . . 13

New Abstract Formats, Key Areas for Consideration . . . . . . . . 14

Submission Guidelines

Submitting a Session Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Submitting a Forum Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Submitting a Presentation Abstract . . . . . . . . . . . . . . . . . . . . . . . 17

Submitting a Workshop Abstract . . . . . . . . . . . . . . . . . . . . . . . . . 18

TABLE OF CONTENTS

IMPORTANT DATES TO REMEMBER

2011 Annual Meeting Call for Proposals Opens . . . . . . . . . . . . . . . . . . . . . August 10, 2010

Deadline for Proposals . . . . . . . . . . . . . . . . . . . . . . . . . .*September 13, 2010 Close of Business

Status Notification of All Proposals . . . . . . . . . . . . . . . . . . . . . . . . . . . . .November 19, 2010

*Deadline extensions will not be granted under any circumstances .

PROGRAM CHAIR

KENNETH A. GETz, MBA

Chairman of CISCRP and Senior Research Fellow at the Tufts Center for the Study of Drug Development

Kenneth A. Getz is the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public awareness of the clinical research enterprise – and a Senior Research Fellow at the Tufts Center for the Study of Drug Development, where he studies R&D management and operating models, investigative site, outsourcing, and study volunteer trends and policies. Ken is also the founder and owner of CenterWatch.

A well-known speaker at conferences, symposia, universities and corporations, Ken has published more than 200 articles and chapters in peer-reviewed journals, books, and in the trade press. He is the author of two nationally recognized books for patients and their advocates titled, Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials and The Gift of Participation, and the recipient of several awards for innovation and scholarship. Ken has held a number of board appointments in the private and public sectors, including serving on the Institute of Medicine’s Clinical Research Roundtable, the DIA Foun-dation, the Consortium to Examine Clinical Research Ethics, and the Clinical Trials Transformation Initiative.

Ken holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Prior to founding CenterWatch, Ken worked for more than seven years in management consulting where he assisted biopharmaceutical companies to develop and implement business strategies to improve clinical development performance.

2

GENERAL INFORMATION

Many New Features and Many More Opportunities to Participate in DIA 2011

The pharmaceutical marketplace is undergoing huge changes that will have a major bear-ing on the kind of business models companies need to employ . Traditional pharmaceuti-cal companies are some of the world’s largest consumer health companies that are now forced to:

• Move into outcomes management by offering combined product-service packages

• Have a more multidisciplinary skills base

• Work more closely with the regulators

• Collaborate with payers and providers to perform continuous trials

Innovation, speed-to-market, and cost-effectiveness are key factors in the life cycle man-agement of pharmaceuticals, medical devices, and related products . Our new Annual Meeting provides you with a comprehensive portfolio of educational opportunities and unparalleled skills at every stage of the pharmaceutical value chain by:

• Bringing together industry professionals, clinicians, patient representatives, and regulatory agencies from all continents

• Facilitating knowledge exchange needed to positively impact innovation and ulti-mately patient care and outcomes

• Building upon DIA’s traditional breadth and depth of topics running the gamut from preclinical research through postmarketing safety and surveillance

• Expanding the discussion of current issues to include new areas such as compara-tive effectiveness, health outcomes, and medical devices

WHAT TO EXPECT AT DIA 2011

You may submit proposals to up to 15 different tracks in a variety of formats, including:

• Sessions

• Presentations

• Workshop Sessions

• Forums

• Professional Posters

Questions related to the 2011 Annual Meeting Program? Contact: [email protected].

3

DEMOGRAPHICS By JOB TITLE

DEMOGRAPHICS By REGION

DEMOGRAPHICS By WORK SETTING

DEMOGRAPHICS By EXPERIENCE LEvEL

4

DIA 2011 will feature presentations geared to attendees from all disciplines and job functions, work settings, experience levels, and geographies . Here is a snapshot of who attended DIA 2010:

2010 DIA ANNuAL MEETING DEMOGRAPHICS

5

2011 aNNual meetiNg tracksThe 2011 DIA Annual Meeting Program Committee invites authors to submit proposals to one of the 15 tracks that will comprise the program. If you have sub mitted in the past, please note that new tracks have been formed for the 2011 program. Please refer to pages 7-12 for track descriptions to ensure that you submit your pro-posal to the correct track for consideration. For example, if you have traditionally submitted to the clinical research/clinical supplies track, please submit your pro-posal to Track 1: Clinical Operations.

l Clinical Research/Clinical Supplies track 1: clinical Operationsl Project Managementl Academic Health Centers/Investigative Sites

l Clinical Research Development track 2: Development Planningl Finance

l Outsourcing track 3: Outsourcing strategies and innovative Partnering models

l Biotechnology track 4: Nonclinical and early clinical Clinical Pharmacologyl Nonclinical translational Development

l Advertising track 5: Product advertising andl Marketing communications

l Medical Communications track 6: medical Writing and communicationsl Medical Writing

l Information Technology track 7: it methods and technologies forl eClinical life science researchl Validation

l Clinical Data Management track 8: life science research informatics Study Endpointsl Document Management and content management

l Regulatory Affairs track 9: regulatory affairs and science,l Chemistry, Manufacturing, and Controls/Good Manufacturing Practices Quality and gxP compliancel Good Clinical Practicesl eSubmissions

l Public Policy/Law/Corporate Compliance track 10: Public Policy/Health care compliance

l Clinical Safety and Pharmacovigilance track 11: clinical safety and Pharmacovigilance

l Statistics track 12: statistics

track 13: Health economics and Outcomes (HeO) comparative effectiveness research (cer) NEW TRACK!

track 14: medical Devices NEW TRACK!

l Professional Development and Training track 15: Professional Development Career/Professional Development

2010 track titles 2011 TRACK TITLES NeW areas iNcOrPOrateD

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tyPes Of PrOPOsals

New for the 2011 annual meeting Program

A variety of proposals are open for submission to the 2011 DIA Annual Meeting Program.

The format and structure of each proposal cannot be altered. No exceptions to the format nor additional number of speakers will be allowed.

NOTE: Internet connectivity will not be available in session rooms.

PreseNtatiON

A 20-minute presentation abstract in a specific topic area; abstract author is considered the speaker. Speaker will deliver topic in a PowerPoint presentation, adhere to DIA guidelines, and address questions from the audience.

Accepted presentation abstracts may be blended with others to form a 90-minute live symposium to be delivered at the Annual Meeting; or ac-cepted presentations may be electronically archived as an eSession.

For presentation abstracts accepted for electronic delivery, such as in the form of a recorded eSession, the author will assist in the develop-ment of this content, including providing a script and questions to facilitate learning.

WOrksHOP

A 90-minute conceptual workshop delivered in an interactive/simula-tion or role-playing format. Onsite learning in the form of activities or demonstrations is required.

Abstract author is considered the workshop chair, must adhere to DIA guidelines, and manage the workshop at the Annual Meeting.

sessiON

A 90-minute session concept delivered lecture-style from the podium. Abstract author is considered the session chair and must coordinate efforts in recruiting speakers (no more than three in a session), adhere to DIA guidelines, and manage the session (including the facilitation of questions and answers from the audience), at the Annual Meeting.

Session chair must ensure good representation/diversity in the selection of speakers; no more than one participant from the same company is permitted. PowerPoint presentations are required from each speaker.

fOrum

A 90-minute forum abstract is a concept abstract with a blend of pre-sentation and panel discussion formats. Abstract author is considered the forum chair and must identify no more than three panel members to participate. Panel member selection should ensure good representation and diversity; no more than one participant from the same company is permitted. PowerPoint presentations are not required.

Abstract author is considered the Chair of the forum and must adhere to DIA guidelines, moderate the forum, and facilitate questions and an-swers from the audience at the Annual Meeting.

new!

new!

new!

7

track 1: cliNical OPeratiONsThe Clinical Operations Track will showcase topics related to the implementation of, and practices associated with, successful clinical trials.

Potential topics in this track include:

• QualityCROandsiteselection,procurement,andclinical trial execution

• Ensuringethicalandsafetreatmentofsubjects• Efficient,effective,andhigh-qualitystudymonitor-

ing practices• Innovativeapproachestoconductingclinicaltrials

(eg,virtualorsemi-virtualenvironments)• Managingsimultaneousglobalclinicaltrialactivity

whileconformingtoevolvingregulatoryrequire-ments

• Patientrecruitment,retention,feasibility,and compliance practices

• Innovativeapproachestoimproveclinicalsupplychainlogistics,cost,andefficiency

• Implementingsponsoroversightoftransferred obligations

• Selection,management,andcoordinationof multiple(ancillary)vendorsonaclinicaltrial

• Investigator/siterelationshipmanagementinthecontextoffulldevelopmentlifecycle(eg,cross-company collaboration re: investigators, key opinion leaders(KOLs),speakers,investigator-initiatedstudies(IIS),etc.

track 2: DevelOPmeNt PlaNNiNg aND maNagemeNt

The Development Planning and Management Track will highlight product (eg, drugs, interven-tions, and medical devices) development topics related to program planning, protocol design, financial and resource planning, and forecasting.


• Protocoldesignandamendmentmanagement• Principles,practices,andtrendsassociatedwith

applied project and portfolio management • Developmentprogramfinancing• Evolvingmethodsformanagingportfoliosand

getting the most out of limited resources• Projectmanagementpracticesandsystems• Projectmanagementinaglobalprogram• Duediligenceandplanningofcontractandthird-

party partnerships (eg, CROs, academic research partners,centralizedservicesproviders)

• Planningtoolsforevaluatingandmanaginginternaland partner performance

track 3: OutsOurciNg strategies aND iNNOvative PartNeriNg mODels

The Outsourcing Strategies and Innovative Part-nering Models Track will address topics related to structuring relationships between sponsors and contract service providers, and between co-development partners, in order to optimize R&D and diversify product portfolios.


• Evolutionofdrugdevelopmentoutsourcing

– Partnering models, outsourcing trends, best practices, and metrics

– Governance, alliance management, and integra-tion between sponsors and service providers

– Full development outsourcing and integration between nonclinical, CMC, regulatory, and clinical development areas

– Role of compliance professionals in vendor management programs

– Current issues in clinical trial ancillary services (centrallab,imaging,lab,ECGcorelab,IVRX,EDC,ePRO,etc.)

– Relationship management

• Portfoliodiversificationpartneringmodels

– Partnering models between biotech, academia, pharma, and CROs

– New venture and funding models (strategic and managementlevel)

– Licensing,co-development,andco-promotionsituations,mergers,andacquisitions

– Acquiringcompoundswithoutdelayingdevelop-ment timelines

– Risk sharing

2011 track tOPics

8

track 4: NONcliNical aND early cliNical traNslatiONal DevelOPmeNt

The Nonclinical and Early Clinical Translational Devel-opment Track will showcase discovery to development topics in the nonclinical, preclinical, and biotechnology arenas.


• Innovative approaches to nonclinical and early clinical safety– Transgenic, disease and new animal models – The value of nonclinical data in the development of

biological medicines– Nonclinicalassessmentofhigh-riskpotentialproducts

• Challengesintheearlydevelopmentofnovelandadvancedtherapies– Challengesinproduction,scale-up,andcharacterization

of novel biologicals – Immunogenicity associated with novel biologicals– Viral safety considerations re: novel expression systems

and cell therapies– Assuringsafetyforfirst-in-man(FIM)

administrationofhigh-riskproducts– Therapeutic opportunities from novel and advanced

biological medicines• Newmethodsthatreducerelianceonanimaltesting• Translationalbiomarkersindrugdevelopment(preclinical,

clinical,safety,andefficacy)• Clinicalpharmacologyandexperimentalmedicine

(new for 201 1 )– Phase0studies(mini-clinis)– Predictive pharmacology and application of biomarkers – Generating early pharmacokinetic data– Novel designs for early phase studies– The value of early phase data in candidate selection– Proof-of-conceptstrategies– Educationandtrainingofclinicalinvestigatorsinvolved

in early development• Earlyinteractionswithregulatoryagencies

– Support of innovation– Pediatric medicines– Scientificadvice

• Exploringdrugdevelopmentfailures

track 5: PrODuct aDvertisiNg aND cOmmuNicatiONs

The Product Advertising and Communications Track will focus on the advertising, promotion, and marketing of pharmaceuticals, and other medical products. Topics will include how advertising/promotion materials and programs are regulated, the political and legislative issues that affect marketing at both the federal and state levels, and innovations that are changing the marketing landscape.


• Advertising/promotionregulationandlegislation of medical and professional education

• Marketresearch• Preparingthemarketfornewproducts• Contractmarketing• Lifecyclemanagement• Innovationsinmarketing(eg,socialmedia)

track 6: meDical WritiNg aND cOmmuNicatiONs

The Medical Writing and Communications Track will focus on efficient and effective scientific and strategic communication to advance health care and well-being and will include communication regarding pharmaceuticals and other medical products to health care professionals, consumers, regulators, payers, patients, and physicians.


• ICHE3clarification(Q&Adocument)• NewISSguidancestatus/update/implications• Pediatrics• Safety:REMS,DSURs(includingcurrentstatus),PRMPs,postmarketing(PSURs),narratives

• Standards:CDISC,DITA,HL7,andglossaryfor non-ITspecialists

• Topic-basedwriting• Emergingmarkets• Medicalscienceliaisons• Provisionofon-labelandoff-labelinformation• Responsedocumentcreationandmaintenance• Literatureevaluation• Contactcenterissues• Innovativetechnologies• Legalandregulatoryaspectsofmedical

communications• Implementationandtechnicalissuesregardingfield-basedmedicalcommunications

2011 track tOPics

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track 7: it metHODs aND tecHNOlOgies fOr life scieNce researcH

The IT Methods and Technologies for Life Science Research Track will focus on capturing, protect-ing, and deploying high-quality information.


• eClinical– Development in eClinical technologies– Semantic interoperability for eClinical information– Benefitsandrisksofaccesstointerimdata– eClinical approaches to postmarketing studies

and patient support• Information Technology

– Integrating health care and clinical research, includingEHRandtheimpactoftheHITECHlegislation

– Semanticsinfrastructuretosupportinteroper-ability(DataElementRepositories,Vocabularyand Terminology Services, BRIDG, Information Model,SemanticWeb)

– Measuring and increasing the value of IT in cost-driventimes

– Designinganddeliveringconfidentiality,integrity,availability, and interoperability with Software as a Service

• Validation– Toolsandtechniquesoncomputerizedsystem

validation– ImpactofnewSLC(systemlifecycle)techniques

and technologies– Data protection/privacy/security– Integration of electronic medical/health record

systems

track 8: life scieNce researcH iNfOrmatics aND cONteNt maNagemeNt

The Life Science Research Informatics and Content Management Track will focus on creat-ing, reviewing, interpreting, and sharing meaning-ful information in life science research.


• Clinical Data Management– CDMandEHR/EMRcasestudies– Scope of CDM in pharmaceutical, biotech,

devices, and CROs– CDM and interfaces to/interactions with other

functions, like pharmacovigilance, medical affairs, regulatory affairs, monitoring, and study management

– Ensuring/measuringdataquality– CDM services beyond the cleaning

of databases: driving the standards develop-ment, moving from managing data to managing information

• Document Management– eLabeling: SPL, PIM, eDRL, PLR – challenges

and opportunities– eSubmission standards: eSignatures, RPS, SDTM,

AdaM,SEND–currentstatusandimpact– Metadata in document management– Content management – enhancing the user

experience• Study Endpoints (new for 2011)

– Best practices in metric standards– Labeling considerations– Qualitativeresearch,psychometrictesting

track 9: regulatOry affairs aND scieNce, Quality aND gXP cOmPliaNceThe Regulatory Affairs and Science, Quality and GXP Compliance Track tends to be 50% “inter-national” by design, to reflect current strong global-ization and harmonization trends in product devel-opment. This track emphasizes regulatory trends, strategic regulatory issues and practices, and tactical issues that affect the regulatory process.


Regulatory Affairs• Adaptiveclinicaltrialdesign• Biomarkers• CriticalPathandPersonalizedMedicinesInitiatives• InnovativeMedicinesInitiative(IMI)• Regulatorystrategiesforglobalproductdevelop-

ment, including emerging markets• REMS,Risk-benefit• FDAAAimplementation• PDUFA,BPCA,andPREAreauthorizationupdates• PediatricalignmentbetweentheUSandEU• ICHqualityguidanceandFDA’srecentCMCandGMP

guidance updates• Recentlegislativeinitiativesconcerningemerging

therapies, medical devices, and combination products

Chemistry, Manufacturing and Controls/ Good Manufacturing Practices• UpdateonICHtopics1:Q11,smallmoleculesand

biotech,Q8/9/10implementationworkinggroup• UpdateonICHtopics2:Residualmetalsandgeno-

toxic impurities (may be a topic together with safetytrack)

• GlobalharmonizationbeyondICH• RegulatoryupdatefromFDAOfficeofNewDrug

QualityAssessment,OfficeofBiotechnologyProd-ucts,andOfficeofGenericDrugs

• ImplementationofQuality-by-designincludinglinktosafetyandefficacy–performance-basedspecifications

2011 track tOPics

Track 9 continued on page 10, left column

10

regulatOry affairs aND scieNce, Quality aND gXP cOmPliaNce

• Quality-by-designandregulatoryflexibilityofanalytical methods

• Inspectionandcomplianceissues:PICs,foreignin-spections,FDA/EUjointinspections

• Complianceissuesrelatedtooutsourcedactivitiesand contract manufacturing

• Qualityriskmanagementinproductdevelopment:theassessment,identification,andcontrolofpotentialrisk

• Knowledgemanagementthroughoutthepharma-ceutical product life cycle

• CMCissuesrelatedtoclinicalholdandrefusetofile• INDCMCexpectations• Practicalmethodsandsolutionsforthemanagement

of corrective and preventive action programs

Electronic Regulatory Submissions• GlobaleSubmissions(EU,US,Canada,Australia,

Switzerland,Japan,ASEAN)andrelatedstandards• eLabeling:SPL,PIM,eDRL,PLR• eSubmissionstandards:eCTD,eSignatures,RPS• eCTDlifecyclemanagementwithinandacross

applications• Regulatoryauthority,eSubmissionexperience,and

eCTD readiness

Good Clinical Practices• DomesticandinternationalGCPregulationsandguid-

ance(ICH)• Singleandjointregulatoryauthorityinspectionsand

current collaborations• GlobalClinicalTrialDisclosurelaw,privacylaws,and

related operational issues• Qualityriskmanagementinproductdevelopment:

Theassessment,identification,andremediationofpotential regulatory and operational risks

• Practicalmethodsandsolutionsforthemanagementof corrective and preventive action programs

• Regulatorycomplianceandqualityassurancerolesinvendor management programs

• Liabilityand risk associated with GCP noncompliance

track 10: Public POlicy/HealtH care cOmPliaNce

The Public Policy and Health Care Compliance Track will focus on issues and concerns in the following areas:

• Whatistheevolvingrelationshipbetweencontem-porary regulatory oversight of industry activities (eg,REMS,DTC)andpotentialonproductliabilityexposure?

• Reviewingoftheinterpretivestandardsforindustryinteractions with health care professionals: health care compliance update and trends in government investigations and settlements

• ImpactofrequirementstopostallformsofreimbursementtoHCPsaspotentialareasofinves-tigation and health care compliance exposure

• Legislativeupdateonnewandimpactfulglobalregulatory changes– Harmonization efforts in risk management pro-

cesses,conflictsofinterestandtransparencyintheUSandtheEU,andtheimpactonindustryinitiatives

• Arewesucceedinginimprovingcommunicationofbenefit/riskincluding;– FDA updates on Transparency Initiative– Updatefrom(FDA)RiskCommunication

Advisory Committee – Examinedifferingperceptionsofriskcommuni-

cationobligations/timingbetweenSEC,FDA, and industryo Managing risk communication responsibilities

betweenpartners(regionallyandglobally)– Examinetheroleofmediaininfluencingrisk

communication and appropriately managing risk

– Reviewdifferingrequirementsfordatadisclosurein evolving global/local clinical trial registrieso Difficultiesincomplyingwithdisparate

requirementso Roleofmedicaljournalrequirements

• Understandingthemissionandpracticalitiesof patient advocacy groups– Who are they? How do they interact with industry?

What do they want and expect from industry? How do they measure their effectiveness/success? What is their impact on regulatory practice, study design, and the new drug approval process?

• Publichealthissues– Re-examiningtheimpactofhealthcarereform

ontheindustry’scomplianceobligations(eg,the“SunshineAct”provisions)–oneyearlater

– Changing the paradigm in drug development and life cycle managemento Patient role and obligations (eg, participation

inclinicaltrials)o Physician role and obligations (eg, participation

inFDAactivitieslikeREMSandpharmaco-vigilance)

• Exploringtheissueofinteractionsbetweenindustryandthehealthcareprocessaspotentialconflictsof interest between industry and health care prac-titioners and examining the impact on compliance obligations and exposure as well as the effect on industryreputationandperception.Forexample– Impact of industry funding on such areas as

investigator-initiatedtrials,“ghostwriting,” speakers’bureaus,andCME

– Addressing the sharp criticism industry has received from such groups as Congress, the DepartmentofJustice/OfficeofInspectorGeneralat HHS, academic medical centers, and editorial boards of medical journals

– Exploringtheimpactofthecurrentconflictofinterest policies of the FDA Board process

2011 track tOPics

Track 9 continued from page 9, right column Track 10 continued from center column

Track 10 continued in right column

11

track 11: cliNical safety aND PHarmacOvigilaNce

The Clinical Safety and Pharmacovigilance Track will feature current practices and new develop-ments that optimize the benefits and minimize risks to patients of investigational and marketed medical products.


• Trainingonbestpracticesforapharmacovigilanceprogram

• Signalstrengtheningandevaluation• Dataminingandsignaldetection• EUriskmanagementplansandUSriskevaluation

andmitigationstrategies(REMS)andtheinterfacebetween these two areas

• Newandemergingsafetyregulations,includingreports on CIOMS and ICH topics

• Classificationandanalysisofsafetydatafrom clinical trials, spontaneous sources, especially in light of nontraditional sources such as registries, investigator-initiatedtrials,patientsupportpro-grams,eMarketingtools,observationalstudies,etc.

• Benefit-riskassessment• Theoryandpracticeofpharmacovigilanceand

safety analysis in specialty areas (eg, product, toxicity,orpopulation-focusedpharmacovigilance)

• RMP/REMSprogrammetrics,auditsandinspections• Postmarketingpharmacovigilanceprogrammetrics,

audits, and inspections• NewEUpharmaceuticallegislationandimpact

on the conduct of pharmacovigilance and EudraVigilance

• OverviewoftheRegulatorySysteminChina• TheInnovativeMedicinesInitiative(IMI)willlaunch

collaborativeR&Dandeducationandtrainingproj-ects on key issues, including new approaches to pharmacovigilance

• Safety:Evidenceandstudydesignsinpersonalizedmedicines

• Implicationsofelectronichealthrecordsand/ormedical records for prospective and retrospective pharmacovigilance

• Signalmanagement(buildingaproductsafetyprofile)

• Pharmacovigilanceinnon-ICHAsia(PacificRim)• Implicationsofandsolutionstocollaborations

amongpartners(variouslicensing,co-development,andco-promotionsituations,mergersand acquisitions)

• Pharmacoepidemiology(useofpharmacoepidem-iologyinpharmacovigilance)

• Practicalaspectsofsafetydatamanagementandsafety databases, and safety sourcing

• Applicationofqualityassessmenttoolsfor pharmacoepidemiology safety study evaluation

• Methodologicalandregulatoryimplicationsof meta-analysesindrugsafety

• Patientlabeling• Patientregistries–advantagesanddisadvantages• FDAICHE2B(R3)update:Testingandmigration

points to consider

track 12: statistics

The Statistics Track will focus on the contributions of statistical science and quantitative thinking throughout the entire clinical product development. Of special interest are contributions of statist icians to broad health care issues and policies, data quality and trial designs. This includes innovative and novel clinical trial designs (eg, adaptive design, Bayesian trials, phase 2 dose-response estimation, and noninferiority trials), issues surrounding the design and analysis of trials (eg, multiregional trials, missing data, decision analytic approaches), issues surrounding data quality (eg, data stan-dards, the Sentinel system, hospital records), and issues resulting from the analyses of clinical trials that will inform health care decisions (eg, meta-analyses, comparative effectiveness research).


• Designandanalysisofmultiregionaltrials• Adaptiveclinicaltrialdesignwithcasestudies• Noninferioritytrials–casestudiesutilizingdraft

guidance• Recentdevelopmentsin“regulatorystatistics”

(eg,ICHguidelinesandCHMPPointstoConsider)• Meta-analysesofsafetyandefficacydata• Statisticalmethodsforportfoliooptimizationand

prioritization of drugs in development• Missingdata–NationalAcademyofSciencereport• Comparativeeffectivenessresearch• DatastandardsincludingCDISC• Bayesianmethodsindrugdevelopment• Analysisofcomplexdata(eg,Sentinelsystemor

hospitalrecords)

Track 11 continued in center column

Track 11 continued from left column

2011 track tOPics

12

NEw fOr 2011track 13: HealtH ecONOmics aND OutcOmes (HeO) cOmParative effectiveNess researcH (cer)

The Health Economics and Outcomes (CER) Track will focus on postapproval research.


• Useofregistrydataineffectivenessstudies• Globalmodelsforeffectivenessstudies• Examineanddiscusslegislation(currentand

future)regardingpricing,reimbursement,and comparative effectiveness

NEw fOr 2011track 14: meDical Devices

The Medical Devices Track will focus on the development and use of medical devices and in vitro diagnostic products.


• Regulatorypathways-to-marketformedical devices

• Clinicaltrialsformedicaldevices• UseofIVDsascompaniondiagnosticsin

personalized medicine• Comparingeffectivenessacrosstherapies

involving drugs and medical devices• GlobalHarmonizationTaskForceupdate• Innovativetechnologyproducts• Convergenceofdrug,biologic,andmedical

device products

track 15: PrOfessiONal DevelOPmeNt

Abstracts for the Professional Development Track will address one of two audiences: individuals in the medical product environment interested in career/professional development and individuals in the medical product environment interested in profession-related learning and/or teaching.

Potential topics for career/professional development in this track may include: • MyBigBreak:Apaneldiscussionwherediverse

senior leaders talk about their career paths and how they got to where they are and what they learned along the way

• GrowingthroughGiving:Personalandprofessionalcontributionandvolunteerism;movingbeyond “the patient is waiting” to patient advocacy/patient fellowship

• MentoringinIndia/MentoringinJapan• Professionaldevelopment:FiguringtheHRworld

into the formula • Speakingtothemedia• Companysizeandprofessionaldevelopment

Potentialtopicsforprofession-relatedlearningand/orteaching in this track may include: • Multiculturallearninginemergingregions,eg,

MiddleEast,Asia/Pacificcountries,LatinAmerica (Brazil,Mexico,others),EasternEurope/Russia (Poland,Romania,others)

• Advancinglearninginintricatecultures(eg,MiddleEast,LatinAmerica,Africatribalareas,Japan,others)

• Learningonthego–mobilelearningandthelatestlearning technologies for speed of knowledge transfer

• Teachingandleadingacrossgenerations• Underthegun:Accountabilityandlearningafter

a regulatory mistake (Other: Learning from our mistakes)

• Howtocalculatereturnoninvestment(ROI)whenteaching intangibles

2011 track tOPics

DEMOGRAPHICS By EXPERIENCE LEvEL

©2010 Brad Yeo c/o theispot.com


47th Annual Meeting

June 19-23, 2011Chicago, IL McCormick Place

Helpful Hints for Submitting Abstracts

NEW ABSTRACT FORMATS FOR DIA 2011

Session: A 90-minute session concept delivered lecture-style from the podium .

Forum: A 90-minute forum abstract is a concept abstract with a blend of pre-sentation and panel discussion formats .

Presentation: A 20-minute presentation abstract in a specific topic area; ab-stract author is considered the speaker .

Workshop Session: A 90-minute conceptual workshop delivered in an interac-tive/simulation or role-playing format . Onsite learning in the form of activities or demonstrations is required .

HELPFuL HINTS

To streamline your submission process and avoid possible delays, DIA strongly encourages you to submit your abstract as early as possible. Do not wait until the last day.

Prepare your abstract separately before accessing the DIA website.

• Abstract information should be copied and pasted from a prepared docu-ment as plain text . For specific details regarding what is required for an abstract, please refer to page 15-18 .

you will need to enter your DIA user ID and password to access the abstract submission pages. If you have forgotten your DIA user ID and password, please visit the Login Reminder.

• Access webinars for online demonstration on how to submit . Visit DIA 2011 website for information .

The individual submitting the abstract will have the option to complete author information even if he or she will not be the designee onsite in Chicago, IL .

• For instance, if you are submitting abstracts for multiple individuals in your organization, you will be noted as the submitter . In addition, at the time of submission, you will be able to identify the author of the abstract . The submitter will be contacted regarding the status of the submitted abstract . Should the abstract be accepted, the author will be the chair or presenter of the abstract .

REQuIRED DOCuMENTATION FOR ALL ABSTRACTS

Participant Disclosure Information

All abstract authors must disclose any significant financial interest or other rela-tionship 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 drugs or devices .

If you are proposing an abstract on behalf of the author, as the submitter you will not be asked to disclose . However, should the abstract be accepted, the author will be informed that he or she must respond to the Participant Disclosure to par-ticipate in the Annual Meeting Program .

Audiovisual Release

Content delivered at the DIA Annual Meeting is recorded and distributed .

All submitters and authors must agree to the DIA Limited License of Written Pro-gram Materials and Assignment of Rights in Recorded Presentations in order for the abstract to be a part of the Annual Meeting Program .

KEy AREAS FOR CONSIDERATION

Your abstract will be evaluated by the 47th DIA Annual Meeting Program Com-mittee from several perspectives, including the following:

• Is your session noncommercial in nature?

• Abstracts should not overtly endorse or recommend a specific product or service . Please CLICK HERE for DIA’s Policy Concerning Promotion of Products and Services from the Podium at DIA-sponsored Programs .

• Is the information within the overall abstract topic, innovative or new? Timeliness and/or relevance of the topic are essential components of all abstracts .

• Who is your target audience and what will they learn?

• Is there a balanced representation of perspectives on the topic (phar-maceutical industry, and/or biotechnology, medical devices, etc; CROs; academia; patients; government etc .)?

• Does the topic offer global perspective(s)?

Please note: All abstracts must be submitted via the DIA website and by the September 13 Close of Business deadline . No exceptions or extensions will be granted .

The format and structure of each abstract is final . Requests for alterations or exceptions will not be accepted . Please be sure to review the format structure and guidelines before submitting your abstract .

DIA and the 47th Annual Meeting Program Committee have the right to re-quest authors to revise their abstracts . Potential revisions include direction of topic, blending an abstract with another submission, or revising the abstract level of difficulty .

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new!

15

Submitter or Author InformationThe following information will need to be completed. Fields followed by an * are required.

Prefix: Country:*First Name:* Address Line:*Middle Name: City:*Last Name:* State/Province:*Name Suffix: Zip/Postal Code:*Degrees: Phone:*Job Title:* eMail:*Company:*

NOTE: If you are submitting on behalf of author, you are considered the SUBMITTER and will need to complete the required information for yourself AND ALSo for the AUTHoR. Submitters will be the contact for author regarding the status of the abstract.If you are submitting your own abstract, you are considered the AUTHoR and will be the direct contact for this abstract.

submission guidelines The following information will be requested at the time of submission.

Submitting a SeSSion AbStrAct (Actual submission must be done online.)

• A session abstract is a 90-minute session concept delivered lecture-style from the podium. The abstract author is considered the session chair and must coordinate efforts in recruiting speakers (no more than three in a session), adhere to DIA guidelines, and manage the session (including the facilitation of questions and answers from the audience), at the Annual Meeting.

• The session chair must ensure good representation/diversity in the selection of speakers; no more than one participant from the same company is permitted. PowerPoint presentations are required from each speaker.

• The format and structure of each session are final. Requests for alterations or exceptions will not be accepted. Please do not request exceptions to the rule.• Please note internet connectivity is not available in the room.

Option to request continuing education credits:At the time of submission, you may request CE credits to be applied to an approved abstract. You may choose one or more types of credits or none at all:

ACPE — Accreditation Council for Pharmacy EducationACCME — Accreditation Council for Continuing Medical EducationIACET — International Association for Continuing Education and TrainingNURSINg — American Nurses Credentialing Center’s Commission on AccreditationPMI — Project Management Institute

If you choose specific CE credits for consideration, a rationale statement will be requested.

Overview (250 character limit, including spaces):Please provide 2-3 sentences summarizing your abstract. This summary will be used as the overview description in the DIA program for marketing purposes.

REquIREd FIEld (To be submitted online.)

Abstract details (2,000 character limit, including spaces):Please provide complete details about your abstract. Information such as scientific, technical, process issues, design/methods, results/outcomes, case studies, statistics, key findings, etc., that would sup-port your proposal should be included here. This information will be used by the Program Committee to learn more about the purpose of your abstract.

REquIREd FIEld (To be submitted online.)level of difficulty (Select one):

O Basic: Appropriate for individuals new to the topic/subject area.O Intermediate: Appropriate for individuals who already have a basic understanding of the topic/

subject area.O Advanced: Appropriate for individuals with an in-depth knowledge of the topic/subject area.

Abstract Title (125 character limit, including spaces): Titles should briefly describe the focus of the abstract as well as accurately reflect the content of the session.


Interest Area/Track: Your proposal must be submitted in one of the 15 tracks that define the DIA Annual Meeting Program. See page 5

Key Words (100 character limit, including spaces): one or more key words must be provided to highlight your session. Examples of key words: Personalized Medicine, Health Technology Assessment, Clinical Trial Agreements.


learning Objectives (300 character limit, including spaces): Please provide 2-3 learning objectives that clearly explain what participants should be able to do after attending this event. For a list of sug-gested verbs to create these objectives, please select the Learning objectives link.



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Submitting a forum AbStrAct (Actual submission must be done online.)

• A 90-minute forum abstract is a concept abstract with a blend of presentation and panel discussion formats. The abstract author is considered the forum chair and must identify no more than three panel members to participate. Panel member selection should ensure good representation and diversity; no more than one participant from the same company is permitted. PowerPoint presentations are not required.

• The format and structure of each forum are final. Requests for alterations or exceptions will not be accepted. Please do not request exceptions to the rule.• Abstract author is considered the Chair of the forum and must adhere to DIA guidelines, moderate the forum, and facilitate questions and answers from the audience at the Annual Meeting. • Please note internet connectivity is not available in the room.




level of difficulty (Select one):



Abstract Title (125 character limit, including spaces): Titles should briefly describe the focus of the abstract as well as accurately reflect the content of the forum.



Key Words (100 character limit, including spaces): one or more key words are to be provided to high-light your forum. Examples of key words: Personalized Medicine, Health Technology Assessment, Clinical Trial Agreements.



Overview (250 character limit, including spaces):Please provide 2-3 sentences summarizing your abstract. This summary will be used as the overview description in the DIA program for marketing purposes.






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Prefix: Country:*

First Name:* Address Line:*

Middle Name: City:*

Last Name:* State/Province:*

Name Suffix: Zip/Postal Code:*

Degrees: Phone:*

Job Title:* eMail:*

Company:*

NOTE: If you are submitting on behalf of author, you are considered the SUBMITTER and will need to complete the required information for yourself AND ALSo for the AUTHoR. Submitters will be the contact for author regarding the status of the abstract.

If you are submitting your own abstract, you are considered the AUTHoR and will be the direct contact for this abstract.


Submitting a preSentAtion AbStrAct (Actual submission must be done online.)

• A presentation abstract is for a 20-minute presentation in a specific topic area; the abstract author is considered the speaker. The speaker will deliver the topic in a PowerPoint presentation, adhere to DIA guidelines, and address questions from the audience.

• The format and structure of each presentation are final. Requests for alterations or exceptions will not be accepted. Please do not request exceptions to the rule.• Accepted presentation abstracts may be blended with others to form a 90-minute live symposium to be delivered at the Annual Meeting. Accepted presentations may be electronically archived as an onsite eSession. • For presentation abstracts accepted for electronic delivery, such as in the form of a recorded eSession, the author will assist in the development of this content, including providing a script and questions to

facilitate learning.• Please note internet connectivity is not available in the room.

Abstract Title (125 character limit, including spaces): Titles should briefly describe the focus of the abstract as well as accurately reflect the content of the presentation.



Key Words (100 character limit, including spaces): one or more key words are to be provided to high-light your presentation. Examples of key words: Personalized Medicine, Health Technology Assessment, Clinical Trial Agreements.













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Submitting a WorkShop AbStrAct (Actual submission must be done online.)

• A workshop is a 90-minute conceptual workshop delivered in an interactive/simulation or role-playing format. on-site learning in the form of activities or demonstrations is required.• The abstract author is considered the Chair of the workshop and must adhere to DIA guidelines and manage the workshop at the Annual Meeting. • The format and structure of each presentation are final. Requests for alterations or exceptions will not be accepted. Please do not request exceptions to the rule.• Please note internet connectivity is not available in the room.




Workshop Interactivity (1,000 character limit, including spaces): Please describe the manner in which this workshop will be interactive and/or how the attendees will participate (role playing, simulation, etc.)


Room/equipment needs (200 character limit, including spaces): Please describe any room setup and/or equipment that you will need for your workshop.


Abstract Title (125 character limit, including spaces): Titles should briefly describe the focus of the abstract as well as accurately reflect the content of the workshop.



Key Words (100 character limit, including spaces): one or more key words are to be provided to high-light your workshop. Examples of key words: Personalized Medicine, Health Technology Assessment, Clinical Trial Agreements.






Overview (250 character limit, including spaces): Please provide 2-3 sentences summarizing your abs-tract. This summary will be used as the overview description in the DIA program for marketing purposes.


Abstract details (2,000 character limit, including spaces): Please provide complete details about your abstract. Information such as scientific, technical, process issues, design/methods, results/outcomes, case studies, statistics, key findings, etc., that would support your proposal should be included here. This information will be used by the Program Committee to learn more about the purpose of your abstract.


learning Objectives (300 character limit, including spaces): Please provide 2-3 learning objectives that clearly explain what participants should be able to do after attending this event. For a list of suggested verbs to create these objectives, please select the Learning objectives link.


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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