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Call for Abstracts                                           CLINICAL TRIAL DISCLOSURE
“Emeralds of Experience”
     presentations                                            learning the landscape and
 DUE BY SEPTEMBER 17, 2007                                    reading the roadmap
November 13-14, 2007                          Hyatt Regency Bonaventure Conference Center and Spa, Weston, FL, USA

PROGRAM CHAIRS                                                This conference will provide practical, pharmaceutical and biotech company-based
BARBARA GODLEW, RN                                            experience/advice and a hands-on conference venue for complying with worldwide
Associate Director, Publication Coordination
                                                              regulations for public disclosure of clinical trial information. Individuals delivering
and Transparency Compliance Exploratory
Development Communications, Novartis                          this conference work inside the industry ensuring company compliance with laws
Pharmaceuticals Corporation                                   and regulations governing the public disclosure of clinical trial information.
PAMELA ROSE, RN, BSN, ASQ-CMQOE                               Knowledge gained from industry-driven experience cannot be overstated.
Director, Clinical Trial Information Registries,
TAP Pharmaceutical Products Inc.


PROGRAM COMMITTEE                                                              This Event is Co-located with 4 other DIA Conferences
TRACY BECK, PhD                                                                     for Added Networking Opportunities!
Global Medical Business Office Consultant; CTR
Results Gatekeeper, Eli Lilly and Company                                                Publication Writing and Building Partnerships
                                                                5
                                                              cated                      DIA Outsourcing Summit
                                                         Co-lo ts
MARGARET M. COBB, MD
Global Leader of J & J Clinical Registry,                                                PMI Pharmaceutical SIG/DIA PM SIAC Joint Conference: The Future of
Johnson & Johnson Pharmaceutical Research                  Even                          Pharmaceutical Project Management – Is a Paradigm Shift Needed?
& Development, LLC
                                                                                         Winning Strategies for Achieving a Quality EDC Clinical Trial Process:
MARY KUSKIN, RPh                                                                         Sponsor/CRO, Investigator, IRB Approver and IT/IS
Director, Regulatory Affairs
Pharmalink Consulting Inc.

GERARD LYNCH
Global Manager, AstraZeneca Clinical Trials
Website, AstraZeneca                                           WHO SHOULD ATTEND
JOHN C. McKENNEY, Sr.                                          Those who will benefit from attending this program include:
President & CEO, SEC Associates Inc.
ROBERT PAARLBERG, MS                                             Clinical trial sponsors                                Pharmaceutical industry and academic
Director, Global Regulatory Policy and Intelligence,             Independent investigators                              clinical researchers
UCB, Inc.                                                        Biotechnology researchers                              Clinical research and development departments
                                                                 Investigator site personnel                            Investigational review boards/ethics
MICHAEL RUBISON
                                                                                                                        committees
Senior Director, Global Medical Research                         Regulatory affairs personnel
and Registration, Abbott Laboratories                                                                                   Clinical quality assurance professionals
                                                                 Medical communications groups
MAUREEN STRANGE
Associate Medical Business Operations Consultant;
CTR Initiated Gatekeeper,
Eli Lilly and Company

PATRICIA TEDEN, MBA                                                         See page 5 for Suggested Abstract Topics and
Independent Consultant                                                            Abstract Submission Guidelines
MILEN VRABEVSKI, MD
Medical Director/CEO, Comac Medical Ltd.

                                                              THIS PROGRAM WAS DEVELOPED BY THE GOOD CLINICAL PRACTICES
                                                              AND QUALITY ASSURANCE CLINICAL TRIAL DISCLOSURE WORKING
                                                              G R O U P A N D T H E C L I N I C A L R E S E A R C H , R E G U L AT O RY A F FA I R S , A N D
For further information, contact                              MEDICAL WRITING SPECIAL INTEREST AREA COMMUNITIES
Ellen Diegel, Program Manager
Phone +1.215.442.6158 / Fax +1.215.442.6199
                                                                 VISIT WWW.DIAHOME.ORG FOR A %
                                                                                             COMPLETE SCHEDULE OF EVENTS!
Ellen.Diegel@diahome.org                               DIA, 800 Enterprise Road, Suite 200, Horsham, PA 19044, USA tel: +1-215-442-6100 fax: +1-215-442-6199 email: dia@diahome.org
Continuing Education
                The Drug Information Association (DIA) has been reviewed and approved as an Authorized Provider by the International Association for Continuing
                Education and Training (IACET), 1620 I Street, NW, Suite 615, Washington, DC 20006. The DIA has awarded up to 1.1 continuing education units (CEUs) to
                participants who successfully complete this program.
 To receive a statement of credit, please visit www.diahome.org. Detailed instructions on how to complete your credit request and download your certifi-
 cate will be provided onsite.
 Disclosure Policy: It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the program audience (1) any
 real or apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty
 disclosure will be included in the course materials.

 Learning Objectives: At the conclusion of this conference, participants should be able to:
   Name the major stakeholders influencing policymaking regarding the disclo-                   Discuss the required, proposed and voluntary requirements for clinical
   sure of clinical trial information                                                           trial registration in the United States and other countries described in the
   Apply for a ClinicalTrials.gov protocol registration account                                 workshop
   Describe how, where, and when to publicly register a clinical trial and to post              Describe the clinical trial lifecycle and the relevance to clinical trial
   clinical trial results                                                                       disclosure
   Plan a clinical trial disclosure process appropriate for their company use                   Explain the relationship between registration and the trial publication plan
   Differentiate relevant differences between major regulations, recommenda-                    Describe processes for ensuring the company is prepared for audit
   tions, and guidelines worldwide




Special 5-in-1 Plenary Session !
                         MONDAY • NOVEMBER 12                                                with the role of the market in health care delivery, contractors
                                                                                             as customers, and the very large amounts spent on R&D.
  4:00-6:00   PM         REGISTRATION                                                        Outsourced costs such as CRO contracts and clinical grants
                                                                                             represent a very large portion of all drug development spending.
                                                                                             Pharmaceutical professionals involved in outsourced activities
                         TUESDAY • NOVEMBER 13
                                                                                             need to understand the role that business plays, and does not
  7:30-8:15   AM        REGISTRATION AND                                                     play, in the entire process, as well as how the major actors
                        CONTINENTAL BREAKFAST                                                involved need to interact with one another.
                                                                                             Professor Harold E. Glass has more than twenty-five years’ international
  8:15-8:30   AM        WELCOME AND OPENING REMARKS
                                                                                             experience in business and in the pharmaceutical industry. He is professor
                                                                                             of health policy at the University of the Sciences in Philadelphia (USP). USP
  8:30-9:15   AM         Plenary Session                                                     has a long legacy in the pharmaceutical industry dating back to University’s
  Join your colleagues from all 5 conferences during this special                            founding in 1821, counting among its distinguished graduates such indus-
  plenary session featuring keynote speaker Harold Glass, PhD,                               try giants as Lilly, Wyeth, Rorer, Smith, Kline, Burroughs, Wellcome,
  followed by a spirited Q&A session.                                                        Warner, Lambert, McNeil and many others. He is also senior research fel-
                                                                                             low at the Centre for Evidence Based Policy at Queen Mary, University of
                                                                                             London.
                         Added Feature!
  Shared refreshment breaks, luncheons, and networking reception                             Dr. Glass holds a MSc (Econ.) from the London School of Economics and a
                                                                                             PhD from the University of North Carolina. He has served on the faculties
  allow for extensive multidisciplinary networking opportunities
                                                                                             of the University of North Carolina and University of Zurich, and has pub-
  among attendees
                                                                                             lished widely in the areas of business strategy and drug development.
                         Keynote Address                                                     Professor Glass is the founder of DataEdge, LLC, which he sold in 2001 to
  DRUG DEVELOPMENT               AS A    BUSINESS: THE ROLE            OF                    IMS Health. DataEdge was a company focusing on drug development and
                                                                                             pharmaceutical marketing.
  OUTSOURCING
  Harold Glass, PhD, Professor, Health Policy, University of the
  Sciences in Philadelphia; President, TTC, LLC                                              9:15-9:45   AM         Q&A Session with Keynote Speaker

  Pharmaceutical drug development is part of a distinctive global
  business, distinguished by: the interaction of health care equity                          9:45-10:15    AM       REFRESHMENT BREAK



Program Agenda for Clinical Trial Disclosure
   10:15-10:30     AM    WELCOME FROM PROGRAM CHAIRPERSONS                                                          Pamela Rose, RN, BSN, ASQ-CMQOE
                         Barbara Godlew, RN                                                                         Director
                         Associate Director, Publication                                                            Clinical Trial Information Registries
                         Coordination and Transparency Compliance                                                   TAP Pharmaceutical Products Inc.
                         Exploratory Development Communications
                         Novartis Pharmaceuticals Corporation


                                                                                      2
10:30 AM-12:00 PM SESSION 1                                                        UNDERSTANDING A NEW STREET MAP: FDA REVITALIZATION
                                                                                   ACT AND CLINICAL TRIAL DISCLOSURE FROM A LEGISLATURE'S
CLINICAL TRIAL LANDSCAPE AND LIFECYCLE:                                            POINT OF VIEW
THE RELATIONSHIP BETWEEN DISCLOSURE AND                    THE                     Speaker Invited
TRIAL PUBLICATION PLAN
CHAIRPERSONS                                                                   3:00-3:30   PM      REFRESHMENT BREAK
Barbara Godlew, RN
Robert Paarlberg, MS                                                           3:30-5:00   PM      SESSION 3
Director, Global Regulatory Policy and Intelligence, UCB, Inc.
                                                                               AFTER THE TRIAL IS COMPLETED: WHAT, WHEN,
The relationship between clinical trial disclosure and the publication         WHERE, AND HOW TO POST TRIAL RESULTS
plan for congress abstracts/posters and completed study manuscript             CHAIRPERSONS
are closely intertwined. This session will examine some of the aspects
                                                                               Tracy Beck, PhD
clinical teams should consider when writing a study protocol as well           Global Medical Business Office Consultant; CTR Results
as identifying key stakeholders to include in the publication planning         Gatekeeper, Eli Lilly and Company
process. Attendees will also gain knowledge on how the patients,
                                                                               Milen Vrabevski, MD
families, and advocates view public disclosure of clinical trial proto-        Medical Director/CEO, Comac Medical Ltd.
cols and results and how public disclosure may impact publication
planning.                                                                      The biopharmaceutical industry has used clinical trial registries and
                                                                               results databases as one way to increase clinical trial transparency
    FROM     THE   EDITOR’S DESK: HOW MUCH        IS   TOO MUCH?               and public trust. Up until recently, the emphasis has been on reg-
    Paul W. Ladenson, MD                                                       istering trials at initiation, but now the focus has shifted towards dis-
    Editor-in-Chief, The Journal of Clinical Endocrinology &                   closing results. This session will examine external stakeholders who
    Metabolism, The Endocrine Society                                          are shaping the landscape of trial disclosure and what potholes to
                                                                               look out for. Attendees will learn what, when, and how to post
    LANDSCAPES AND LIFECYCLES: FROM         THE   PERSPECTIVE    OF THE        results summaries, as well as how to avoid risks of off-label promo-
    PUBLICATION PLAN                                                           tion when creating the summaries for public disclosure.
    Barbara Godlew, RN
    Robert Paarlberg, MS                                                           BRIEF OVERVIEW     OF   CURRENT REQUIREMENTS      FOR   POSTING
                                                                                   RESULTS
    THE PATH TOWARDS ACCESS AND TRANSPARENCY:                                      Pamela Rose, RN, BSN, ASQ-CMQOE
    THE PATIENTS’ POINT OF VIEW                                                    WHAT, WHERE,      AND   HOW   TO   POST RESULTS
    Pat Furlong                                                                    Tracy Beck, PhD
    President, Parent Project Muscular Dystrophy
                                                                                   HOW TO AVOID THE RISKS        OF   OFF-LABEL PROMOTION      IN
                                                                                   RESULTS SUMMARIES
12:00-1:30   PM       LUNCHEON
                                                                                   Bob Naidus, JD
                                                                                   Senior Pharmaceutical Counsel, Novartis Pharmaceuticals
1:30-3:00   PM        SESSION 2                                                    Corporation
STAKEHOLDER STREET MAPS: A WORLDWIDE OVERVIEW
                                                                               5:30-6:45   PM      NETWORKING RECEPTION
TO CLINICAL TRIAL DISCLOSURE
                                                                                                   SPONSORED BY THE GOOD CLINICAL PRACTICES
CHAIRPERSONS
                                                                                                   AND QUALITY ASSURANCE CLINICAL TRIAL
Gerard Lynch                                                                                       DISCLOSURE WORKING GROUP AND THE
Global Manager, AstraZeneca Clinical Trials Website
                                                                                                   CLINICAL RESEARCH, REGULATORY AFFAIRS AND
Michael Rubison, PhD                                                                               MEDICAL WRITING SPECIAL INTEREST AREA
Senior Director, Global Medical Research and Registration,
                                                                                                   COMMUNITIES
Abbott Laboratories
This session provides an introduction to the major themes of the con-
ference and provides an overview of the laws and policies associated                               WEDNESDAY • NOVEMBER 14
with transparency of clinical trial registration and results disclosure.
This overview will include US federal and state legislation, interna-          7:30-8:30   AM      REGISTRATION AND
tional policies and institutional agreements for both required and                                 CONTINENTAL BREAKFAST
voluntary compliance, and the key issues that have driven clinical
trial transparency. The international research and regulatory commu-           8:30-10:00 AM       SESSION 4
nity has responded with a large array of databases and database
standards proposed by international, national, regional healthcare             READING AND FOLLOWING THE ROAD MAP: PUBLIC
and regulatory groups, pharmaceutical companies, academic institu-             REGISTRATION OF CLINICAL PROTOCOL INFORMATION
tions, professional societies, patient advocate and therapeutic                CHAIRPERSONS
specialty groups.                                                              Barbara Godlew, RN
                                                                               Maureen Strange
    KEY MILESTONES AND ISSUES: A CHRONOLOGICAL HISTORY               OF
                                                                               Associate Medical Business Operations Consultant; CTR Initiated
    CLINICAL TRIAL DISCLOSURE                                                  Gatekeeper, Eli Lilly and Company
    Gerard Lynch
    Michael Rubison, Phd                                                       Passed, pending, and proposed clinical trial registry legislation pro-
                                                                               vides an array of confusing and sometimes conflicting articles and


                                                                           3
requirements for both the end users and the registry administrators.                  Pamela Rose, RN, BSN, ASQ-CMQOE
 This session will provide attendees with clarity on recent develop-
                                                                                       State of Maine regulations require that publicly disclosed clinical
 ments in federal legislation and challenges the staff at the National
                                                                                       trial information must be “reliable, accurate and true.” The FDA
 Library of Medicine face in complying with the requirements.
                                                                                       Revitalization Act bill currently pending in Congress declares that clin-
 Attendees will also gain knowledge in the functional use of
                                                                                       ical trial registry and results database information “shall not be false
 ClinicalTrials.gov as we build a record in the registry, step-by-step,
                                                                                       or misleading in any particular.” Finally, the IFPMA statement on
 and answer audience questions during this process.
                                                                                       clinical trial disclosure calls for companies to “establish a process of
      FINDING AND UNFOLDING THE MAP: LEGISLATION                                       verification” and to “make public how they will adhere to” the stan-
      SURROUNDING CLINICALTRIALS.GOV                                                   dards defined in the statement. Collectively, these statements build a
      Rebecca Williams, PharmD                                                         compelling argument for instituting a robust audit program to assess
      Assistant Director, ClinicalTrials.gov, National Library                         your organization’s trial disclosures. This session includes an overview
      of Medicine                                                                      of the key components comprising a sound clinical trial disclosure
                                                                                       audit. The highlight of the session consists of a panel discussion
      YES! YOU CAN REGISTER A TRIAL TO CLINICALTRIALS.GOV
                                                                                       featuring industry professionals who have been audited or have
      WITHOUT AGLOBAL POSITIONING SYSTEM AND WE’LL SHOW
                                                                                       conducted audits of clinical trial disclosures. Attendees are invited
      YOU HOW !!!
                                                                                       to come armed with their most pressing questions to pose to our
      Annice Bergeris
      Information Research Specialist, National Library of Medicine                    panelists on this timely and critical topic. Participants will leave this
      (assistance provided by Barbara Godlew and Maureen Strange)                      session with increased understanding and appreciation of how to
                                                                                       prepare for, and what to expect during, a clinical disclosure audit.
 10:00-10:30      AM   REFRESHMENT BREAK
                                                                                            PANELISTS
 10:30 AM-12:00 PM SESSION 5                                                                   Auditee Perspective
                                                                                               Shawn M. Pelletier
 HERDING CATS THROUGH CANYONS: DEVELOPING                           A
                                                                                               Associate Director R&D Operations
 COMPANY PROCESS FOR PUBLIC DISCLOSURE                                                         Bristol-Myers Squibb Company
 CHAIRPERSONS
                                                                                               Valerie V. Phillips, MA
 Margaret M. Cobb, MD, PhD                                                                     Manager Clinical Trial Disclosure
 Global Leader of J & J Clinical Registry, Johnson & Johnson                                   Pfizer Inc
 Pharmaceutical Research & Development, LLC
 Patricia Teden, MBA                                                                           Auditor Perspective
 Independent Consultant                                                                        John C. McKenney, Sr.
                                                                                               Beat E. Widler, PhD
 Creating a business process that is accurate, predictable, and capable of
                                                                                               Global Head of Clinical Quality Assurance
 meeting the changing needs for disclosing information about clinical trials
                                                                                               F. Hoffmann-La Roche
 in multiple study registries and results databases is difficult. Companies
 need to leverage their current clinical trial process, determine if the disclo-
 sure steps will be centralized or decentralized, determine how much to                3:00-3:30   PM        REFRESHMENT BREAK
 leverage technology, and decide whether, and how, to use outside
 resources. During this session, we will hear how a large pharma, a small              3:30-5:00   PM        SESSION 7
 biopharmaceutical company, and a device company developed their clini-
 cal trial disclosure business process.
                                                                                       “EMERALDS        OF   EXPERIENCE”
      HERDING BIG PHARMA CATS …                                                        AVOIDING ACCIDENTS: CLINICAL TRIAL DISCLOSURE
      Margaret M. Cobb, MD, PhD                                                        LESSONS LEARNED
                                                                                       CHAIRPERSON
      SMALL PHARMA: THE CATS          WITH   MANY HATS
      Anthony K. Taylor, Sr.                                                           Mary Kuskin, RPh
      Clinical Operations Coordinator, Targanta Therapeutics                           Director, Regulatory Affairs, Pharmalink Consulting Inc.
      Corporation                                                                      The field of clinical trial disclosure has expanded dramatically in
                                                                                       the last ten years. There has been a steady increase in the reach
      A DEVICE COMPANY        AND   COMBINATION PRODUCTS PERSPECTIVE
      Lisa Griffin Vincent, PhD, MA                                                    of stakeholders, regulations and experience on a global scale. The
      Senior Director, Corporate Clinical Research & Development,                      strategy for posting and maintaining clinical trial information finds a
      Medtronic Inc.                                                                   place in the overall development and lifecycle strategy for biophar-
                                                                                       maceutical and medical device companies. This session will highlight
 12:00-1:30   PM       LUNCHEON                                                        individuals’ experiences along this path to share the practical aspects
                                                                                       of balancing regulation compliance with presentation of meaningful
 1:30-3:00   PM        SESSION 6                                                       information on clinical trial databases.
 ARE YOU READY? PREPARING                 FOR   AUDIT     OF   CLINICAL
 TRIAL DISCLOSURES
 CHAIRPERSONS                                                                          5:00   PM             CONFERENCE ADJOURNED
 John C. McKenney, Sr.
 President & CEO, SEC Associates Inc.

Statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association.
                                               Speakers and agenda are subject to change without notice.
                Recording of information, in any type of media, is prohibited at all DIA events without prior written consent from DIA.
                                                                                   4
“Emeralds of Experience” Information
The Drug Information Association (DIA) is offering a unique opportunity for presenters at                 The Clinical Trial Disclosure “Emeralds of Experience” session is sched-
the DIA Clinical Trial Disclosure conference in Weston, FL.                                               uled for Wednesday, November 14, 2007 at 3:30 pm.
A podium session will provide those in the clinical trial disclosure field an opportunity to              Those interested in participating in the 15-minute podium presentation
share their successes, challenges, and “Emeralds of Experience” on various topics with                    session should submit an abstract on the topic and information that
their DIA Clinical Trial Disclosure colleagues. Participants can share their experiences and              will be presented. Due to the limited time available for podium presen-
“emeralds” by developing a 15-minute presentation.                                                        tations, only 4 (four) “Emeralds” will be accepted. A subset of the
Suggested Abstract Topics:                                                                                program committee will review and select from the topics submitted,
                                                                                                          if necessary. For those interested in submitting a poster, authors
   Stakeholder Street Maps: A Worldwide Overview to Clinical Trial Disclosure Law
                                                                                                          should submit an abstract according to the Guidelines for Abstract
   Reading and Following the Road Map: Public Registration of Clinical Protocol
                                                                                                          Submission below.
   Information
   After the Trial is Completed: What, When, Where, and How to Post Trial Results                         DEADLINE FOR SUBMISSIONS IS SEPTEMBER 17, 2007.
   Clinical Trial Landscape and Lifecycle: The Relationship between Registration and
   the Trial Publication Plan                                                                             ALL ENTRIES MUST BE SUBMITTED ONLINE.
   Herding Cats through Canyons: Developing a Company Process for Public Disclosure                       http://www.diahome.org/DIAHOME/GetInvolved/
   Are You Ready? Preparing for Audit of Public Disclosure Processes                                      AbstractSubmissionLauncher.aspx


  Guidelines for Abstract Submission
All abstracts must be received by September 17, 2007. Authors of selected abstracts                       1. At time of electronic submission of abstracts, all speakers must
will be notified by September 28, 2007. Please provide the following information                             complete the speaker disclosure section of the electronic submission
using the online abstract form:                                                                              form.
                                                                                                          2. Preference will be given to submitted abstracts that address real-life
PRIMARY TOPIC AREA
                                                                                                             applications and case studies.
SPEAKER NAME (Degrees, job title)                                                                         3. Final PowerPoint presentation for all accepted abstracts will be due
AFFILIATION (Mailing address, phone number, fax number, eMail)                                               to DIA by October 23, 2007 to be reviewed by the committee and
                                                                                                             included in the attendee registration packet. Should you choose to
PRESENTATION TITLE                                                                                           submit an abstract for consideration, please mark your calendars
SUMMARY (approximately 2-3 sentences) suitable for inclusion in preliminary program,                         with this deadline.
if selected                                                                                               4. Final PowerPoint presentations for all accepted abstracts may have
LEARNING OBJECTIVES (Please provide two learning objectives to inform the learner                            a company logo on slide number one. Any company logo appearing
of what he/she should be able to do after attending your session.                                            on any other slides will be removed by DIA.
                                                                                                          5. Time allotted for individual presentations will be approximately
ABSTRACT (300 words or less)                                                                                 15-20 minutes. Final timing will be determined by the session chair
                                                                                                             and based on the number of presentations selected for the session.
DISCLOSURE INFORMATION                                                                                    6. DIA will provide complimentary conference attendance for the
All speakers must disclose any significant financial interest or other relationship                          selected presenter.
with the manufacturer(s) of any commercial product(s) and/or providers of commercial                      7. Please note: Only one presenter per presentation will be allowed.
services discussed in an educational presentation, as well as any discussion of                              Any exceptions to this policy must be discussed with the DIA office
unlabeled or unapproved drugs or devices.                                                                    in advance.




TRAVEL AND HOTEL The most convenient airport is Fort Lauderdale/Hollywood                        UNITED AIRLINES & US AIRWAYS
International Airport and attendees should make airline reservations as early as                 Save through Area Pricing and Discount Fees
possible to ensure availability. The Hyatt Regency Bonaventure Conference
Center and Spa is holding a block of rooms at the reduced rate below until                       To obtain schedule information and the best fares, call United Airlines’s
October 22, 2007, for the DIA event attendees. Room availability at this rate                    Specialized Meeting Reservations Center at 1-800-521-4041. Make sure you
is guaranteed only until this date or until the block is filled.                                 refer to Meeting ID Number 571AK. Dedicated reservationists are on duty 7
                          Single $189           Double $214                                      days a week from 8:00 AM to 10:00 PM EST.
Please contact the Conference Center by telephone at +1-954-616-1234 or                          This special offer applies to travel on domestic segments of all United Airlines,
+1-800-233-1234 and mention the DIA event. The hotel is located at 250                           United Express, PED, and United code share flights (UA*, operated by US
Racquet Club Road, Weston, FL 33326, USA.                                                        Airways, US Airways Express and Air Canada).

GROUP DISCOUNTS* Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the
same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA mem-
bership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available
online and does not apply to the already-discounted fees for government or charitable nonprofit/academia.
   To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group
   registrants on each of the forms and return them together to DIA.

Participants with Disabilities: DIA event facilities and overnight accommodations are accessible to persons with disabilities. Services will be made available to
sensory-impaired persons attending the event if requested at least 15 days prior to event. Contact the DIA office to indicate your needs.                                        5
Drug Information Association                                                                                                                                           www.diahome.org



CLINICAL TRIAL DISCLOSURE                                                                                                                                             CALL FOR ABSTRACTS
                                                                                                                                                             “Emeralds of Experience” presentations
learning the landscape and                                                                                                                                          DUE BY SEPTEMBER 17

reading the roadmap
                                                                                                                   5 Co-located Events for Added Networking Opportunities!
Hyatt Regency Bonaventure Conference                                                                                      DIA Outsourcing Summit
Center and Spa, Weston, FL, USA                                                                                           Publication Writing and Building Partnerships
                                                                                                                          PMI Pharmaceutical SIG/ DIA PM SIAC Joint Conference: The Future of
NOVEMBER 13-14, 2007 |                                       Event ID #07039                                              Pharmaceutical Project Management – Is a Paradigm Shift Needed?
                                                                                                                          Winning Strategies for Achieving a Quality EDC Clinical Trial Process
MEMBER EARLY BIRD                       Register by OCT. 23, 2007               SAVE $175
Register online or fax this page to +1-215-442-6199                                               DRUG INFORMATION ASSOCIATION
                                                                                                  800 Enterprise Road, Suite 200
                                                                                                  Horsham, PA 19044-3595 USA
     CONTACT & TABLETOP EXHIBIT INFORMATION
     Attendees may visit the tabletop exhibits during the event and during receptions
     (if applicable).
     Event information: Contact Ellen Diegel at the DIA office by telephone +1-215-442-
     6158, fax +1-215-442-6199 or email Ellen.Diegel@diahome.org.
     Tabletop exhibit information: Contact Erin Gilliland, Exhibits Associate, at the DIA
     office by telephone +1-215-442-6149, fax +1-215-442-6199 or email Erin.Gilliland@
     diahome.org. For tabletop exhibit space, please check the box below.

         To receive a tabletop exhibit application, please check.

     GROUP DISCOUNTS (not available online or on already discounted fees)
     Register 3 individuals from the same company and receive complimentary registration
     for a 4th! All 4 individuals must register and prepay at the same time – no exceptions.
     See page 5 for complete details.

Registration Fees If DIA cannot verify your membership upon receipt of registration               REGISTRATION FORM                            Do not remove mailing label. Please return this entire page.                    07039
form, you will be charged the nonmember fee. Registration fee includes refreshment breaks,                                                     PLEASE CONSIDER THIS FORM AN INVOICE
luncheons, and reception (if applicable), and will be accepted by mail, fax, or online.           Please check the applicable category:
                                                                                                     Academia                 Government                Industry        CSO         Student (Call for registration information)
MEMBER EARLY-BIRD OPPORTUNITY                          On or before                    After
Available on nondiscount member fee only              OCT. 23, 2007           OCT. 23, 2007
                                                                                                  Last Name       Check if part of group registration              First Name                                                  M.I.
Member Fee                                          US $1165                 US $1340
                                                                                                  Degrees                                                                                                       Dr.      Mr.          Ms.
Join DIA now to qualify for the early-bird                                   MEMBERSHIP
member fee! www.diahome.org/en/Membership/                                   US $ 130             Job Title
AboutMembership/AboutMembership
To qualify for the early-bird discount, registration form and accompanying payment must be        Company
received by the date above. Does not apply to government/academia/nonprofit members.
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fee. If paying a nonmember fee, please indicate if you do, or do not, want membership.
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  Government (Full-time)                            US $ 300                US $ 430
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*If paying a nonmember fee, please check one box above, indicating whether you want membership.   Group Registrant #3 Last Name                                    First Name          Completed form required for each group registrant


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     Tutorial (if applicable) = $50                                                                      non-U.S. credit card payment will be subject to the currency conversion rate at the time of the charge.
     Cancellations must be in writing and be received by the cancellation date above.                         Visa          MC              AMEX                   Exp Date     _______________________________________
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Anthony Presentation DIA Florida Ctd Nov2007

  • 1. Call for Abstracts CLINICAL TRIAL DISCLOSURE “Emeralds of Experience” presentations learning the landscape and DUE BY SEPTEMBER 17, 2007 reading the roadmap November 13-14, 2007 Hyatt Regency Bonaventure Conference Center and Spa, Weston, FL, USA PROGRAM CHAIRS This conference will provide practical, pharmaceutical and biotech company-based BARBARA GODLEW, RN experience/advice and a hands-on conference venue for complying with worldwide Associate Director, Publication Coordination regulations for public disclosure of clinical trial information. Individuals delivering and Transparency Compliance Exploratory Development Communications, Novartis this conference work inside the industry ensuring company compliance with laws Pharmaceuticals Corporation and regulations governing the public disclosure of clinical trial information. PAMELA ROSE, RN, BSN, ASQ-CMQOE Knowledge gained from industry-driven experience cannot be overstated. Director, Clinical Trial Information Registries, TAP Pharmaceutical Products Inc. PROGRAM COMMITTEE This Event is Co-located with 4 other DIA Conferences TRACY BECK, PhD for Added Networking Opportunities! Global Medical Business Office Consultant; CTR Results Gatekeeper, Eli Lilly and Company Publication Writing and Building Partnerships 5 cated DIA Outsourcing Summit Co-lo ts MARGARET M. COBB, MD Global Leader of J & J Clinical Registry, PMI Pharmaceutical SIG/DIA PM SIAC Joint Conference: The Future of Johnson & Johnson Pharmaceutical Research Even Pharmaceutical Project Management – Is a Paradigm Shift Needed? & Development, LLC Winning Strategies for Achieving a Quality EDC Clinical Trial Process: MARY KUSKIN, RPh Sponsor/CRO, Investigator, IRB Approver and IT/IS Director, Regulatory Affairs Pharmalink Consulting Inc. GERARD LYNCH Global Manager, AstraZeneca Clinical Trials Website, AstraZeneca WHO SHOULD ATTEND JOHN C. McKENNEY, Sr. Those who will benefit from attending this program include: President & CEO, SEC Associates Inc. ROBERT PAARLBERG, MS Clinical trial sponsors Pharmaceutical industry and academic Director, Global Regulatory Policy and Intelligence, Independent investigators clinical researchers UCB, Inc. Biotechnology researchers Clinical research and development departments Investigator site personnel Investigational review boards/ethics MICHAEL RUBISON committees Senior Director, Global Medical Research Regulatory affairs personnel and Registration, Abbott Laboratories Clinical quality assurance professionals Medical communications groups MAUREEN STRANGE Associate Medical Business Operations Consultant; CTR Initiated Gatekeeper, Eli Lilly and Company PATRICIA TEDEN, MBA See page 5 for Suggested Abstract Topics and Independent Consultant Abstract Submission Guidelines MILEN VRABEVSKI, MD Medical Director/CEO, Comac Medical Ltd. THIS PROGRAM WAS DEVELOPED BY THE GOOD CLINICAL PRACTICES AND QUALITY ASSURANCE CLINICAL TRIAL DISCLOSURE WORKING G R O U P A N D T H E C L I N I C A L R E S E A R C H , R E G U L AT O RY A F FA I R S , A N D For further information, contact MEDICAL WRITING SPECIAL INTEREST AREA COMMUNITIES Ellen Diegel, Program Manager Phone +1.215.442.6158 / Fax +1.215.442.6199 VISIT WWW.DIAHOME.ORG FOR A % COMPLETE SCHEDULE OF EVENTS! Ellen.Diegel@diahome.org DIA, 800 Enterprise Road, Suite 200, Horsham, PA 19044, USA tel: +1-215-442-6100 fax: +1-215-442-6199 email: dia@diahome.org
  • 2. Continuing Education The Drug Information Association (DIA) has been reviewed and approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1620 I Street, NW, Suite 615, Washington, DC 20006. The DIA has awarded up to 1.1 continuing education units (CEUs) to participants who successfully complete this program. To receive a statement of credit, please visit www.diahome.org. Detailed instructions on how to complete your credit request and download your certifi- cate will be provided onsite. Disclosure Policy: It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosure will be included in the course materials. Learning Objectives: At the conclusion of this conference, participants should be able to: Name the major stakeholders influencing policymaking regarding the disclo- Discuss the required, proposed and voluntary requirements for clinical sure of clinical trial information trial registration in the United States and other countries described in the Apply for a ClinicalTrials.gov protocol registration account workshop Describe how, where, and when to publicly register a clinical trial and to post Describe the clinical trial lifecycle and the relevance to clinical trial clinical trial results disclosure Plan a clinical trial disclosure process appropriate for their company use Explain the relationship between registration and the trial publication plan Differentiate relevant differences between major regulations, recommenda- Describe processes for ensuring the company is prepared for audit tions, and guidelines worldwide Special 5-in-1 Plenary Session ! MONDAY • NOVEMBER 12 with the role of the market in health care delivery, contractors as customers, and the very large amounts spent on R&D. 4:00-6:00 PM REGISTRATION Outsourced costs such as CRO contracts and clinical grants represent a very large portion of all drug development spending. Pharmaceutical professionals involved in outsourced activities TUESDAY • NOVEMBER 13 need to understand the role that business plays, and does not 7:30-8:15 AM REGISTRATION AND play, in the entire process, as well as how the major actors CONTINENTAL BREAKFAST involved need to interact with one another. Professor Harold E. Glass has more than twenty-five years’ international 8:15-8:30 AM WELCOME AND OPENING REMARKS experience in business and in the pharmaceutical industry. He is professor of health policy at the University of the Sciences in Philadelphia (USP). USP 8:30-9:15 AM Plenary Session has a long legacy in the pharmaceutical industry dating back to University’s Join your colleagues from all 5 conferences during this special founding in 1821, counting among its distinguished graduates such indus- plenary session featuring keynote speaker Harold Glass, PhD, try giants as Lilly, Wyeth, Rorer, Smith, Kline, Burroughs, Wellcome, followed by a spirited Q&A session. Warner, Lambert, McNeil and many others. He is also senior research fel- low at the Centre for Evidence Based Policy at Queen Mary, University of London. Added Feature! Shared refreshment breaks, luncheons, and networking reception Dr. Glass holds a MSc (Econ.) from the London School of Economics and a PhD from the University of North Carolina. He has served on the faculties allow for extensive multidisciplinary networking opportunities of the University of North Carolina and University of Zurich, and has pub- among attendees lished widely in the areas of business strategy and drug development. Keynote Address Professor Glass is the founder of DataEdge, LLC, which he sold in 2001 to DRUG DEVELOPMENT AS A BUSINESS: THE ROLE OF IMS Health. DataEdge was a company focusing on drug development and pharmaceutical marketing. OUTSOURCING Harold Glass, PhD, Professor, Health Policy, University of the Sciences in Philadelphia; President, TTC, LLC 9:15-9:45 AM Q&A Session with Keynote Speaker Pharmaceutical drug development is part of a distinctive global business, distinguished by: the interaction of health care equity 9:45-10:15 AM REFRESHMENT BREAK Program Agenda for Clinical Trial Disclosure 10:15-10:30 AM WELCOME FROM PROGRAM CHAIRPERSONS Pamela Rose, RN, BSN, ASQ-CMQOE Barbara Godlew, RN Director Associate Director, Publication Clinical Trial Information Registries Coordination and Transparency Compliance TAP Pharmaceutical Products Inc. Exploratory Development Communications Novartis Pharmaceuticals Corporation 2
  • 3. 10:30 AM-12:00 PM SESSION 1 UNDERSTANDING A NEW STREET MAP: FDA REVITALIZATION ACT AND CLINICAL TRIAL DISCLOSURE FROM A LEGISLATURE'S CLINICAL TRIAL LANDSCAPE AND LIFECYCLE: POINT OF VIEW THE RELATIONSHIP BETWEEN DISCLOSURE AND THE Speaker Invited TRIAL PUBLICATION PLAN CHAIRPERSONS 3:00-3:30 PM REFRESHMENT BREAK Barbara Godlew, RN Robert Paarlberg, MS 3:30-5:00 PM SESSION 3 Director, Global Regulatory Policy and Intelligence, UCB, Inc. AFTER THE TRIAL IS COMPLETED: WHAT, WHEN, The relationship between clinical trial disclosure and the publication WHERE, AND HOW TO POST TRIAL RESULTS plan for congress abstracts/posters and completed study manuscript CHAIRPERSONS are closely intertwined. This session will examine some of the aspects Tracy Beck, PhD clinical teams should consider when writing a study protocol as well Global Medical Business Office Consultant; CTR Results as identifying key stakeholders to include in the publication planning Gatekeeper, Eli Lilly and Company process. Attendees will also gain knowledge on how the patients, Milen Vrabevski, MD families, and advocates view public disclosure of clinical trial proto- Medical Director/CEO, Comac Medical Ltd. cols and results and how public disclosure may impact publication planning. The biopharmaceutical industry has used clinical trial registries and results databases as one way to increase clinical trial transparency FROM THE EDITOR’S DESK: HOW MUCH IS TOO MUCH? and public trust. Up until recently, the emphasis has been on reg- Paul W. Ladenson, MD istering trials at initiation, but now the focus has shifted towards dis- Editor-in-Chief, The Journal of Clinical Endocrinology & closing results. This session will examine external stakeholders who Metabolism, The Endocrine Society are shaping the landscape of trial disclosure and what potholes to look out for. Attendees will learn what, when, and how to post LANDSCAPES AND LIFECYCLES: FROM THE PERSPECTIVE OF THE results summaries, as well as how to avoid risks of off-label promo- PUBLICATION PLAN tion when creating the summaries for public disclosure. Barbara Godlew, RN Robert Paarlberg, MS BRIEF OVERVIEW OF CURRENT REQUIREMENTS FOR POSTING RESULTS THE PATH TOWARDS ACCESS AND TRANSPARENCY: Pamela Rose, RN, BSN, ASQ-CMQOE THE PATIENTS’ POINT OF VIEW WHAT, WHERE, AND HOW TO POST RESULTS Pat Furlong Tracy Beck, PhD President, Parent Project Muscular Dystrophy HOW TO AVOID THE RISKS OF OFF-LABEL PROMOTION IN RESULTS SUMMARIES 12:00-1:30 PM LUNCHEON Bob Naidus, JD Senior Pharmaceutical Counsel, Novartis Pharmaceuticals 1:30-3:00 PM SESSION 2 Corporation STAKEHOLDER STREET MAPS: A WORLDWIDE OVERVIEW 5:30-6:45 PM NETWORKING RECEPTION TO CLINICAL TRIAL DISCLOSURE SPONSORED BY THE GOOD CLINICAL PRACTICES CHAIRPERSONS AND QUALITY ASSURANCE CLINICAL TRIAL Gerard Lynch DISCLOSURE WORKING GROUP AND THE Global Manager, AstraZeneca Clinical Trials Website CLINICAL RESEARCH, REGULATORY AFFAIRS AND Michael Rubison, PhD MEDICAL WRITING SPECIAL INTEREST AREA Senior Director, Global Medical Research and Registration, COMMUNITIES Abbott Laboratories This session provides an introduction to the major themes of the con- ference and provides an overview of the laws and policies associated WEDNESDAY • NOVEMBER 14 with transparency of clinical trial registration and results disclosure. This overview will include US federal and state legislation, interna- 7:30-8:30 AM REGISTRATION AND tional policies and institutional agreements for both required and CONTINENTAL BREAKFAST voluntary compliance, and the key issues that have driven clinical trial transparency. The international research and regulatory commu- 8:30-10:00 AM SESSION 4 nity has responded with a large array of databases and database standards proposed by international, national, regional healthcare READING AND FOLLOWING THE ROAD MAP: PUBLIC and regulatory groups, pharmaceutical companies, academic institu- REGISTRATION OF CLINICAL PROTOCOL INFORMATION tions, professional societies, patient advocate and therapeutic CHAIRPERSONS specialty groups. Barbara Godlew, RN Maureen Strange KEY MILESTONES AND ISSUES: A CHRONOLOGICAL HISTORY OF Associate Medical Business Operations Consultant; CTR Initiated CLINICAL TRIAL DISCLOSURE Gatekeeper, Eli Lilly and Company Gerard Lynch Michael Rubison, Phd Passed, pending, and proposed clinical trial registry legislation pro- vides an array of confusing and sometimes conflicting articles and 3
  • 4. requirements for both the end users and the registry administrators. Pamela Rose, RN, BSN, ASQ-CMQOE This session will provide attendees with clarity on recent develop- State of Maine regulations require that publicly disclosed clinical ments in federal legislation and challenges the staff at the National trial information must be “reliable, accurate and true.” The FDA Library of Medicine face in complying with the requirements. Revitalization Act bill currently pending in Congress declares that clin- Attendees will also gain knowledge in the functional use of ical trial registry and results database information “shall not be false ClinicalTrials.gov as we build a record in the registry, step-by-step, or misleading in any particular.” Finally, the IFPMA statement on and answer audience questions during this process. clinical trial disclosure calls for companies to “establish a process of FINDING AND UNFOLDING THE MAP: LEGISLATION verification” and to “make public how they will adhere to” the stan- SURROUNDING CLINICALTRIALS.GOV dards defined in the statement. Collectively, these statements build a Rebecca Williams, PharmD compelling argument for instituting a robust audit program to assess Assistant Director, ClinicalTrials.gov, National Library your organization’s trial disclosures. This session includes an overview of Medicine of the key components comprising a sound clinical trial disclosure audit. The highlight of the session consists of a panel discussion YES! YOU CAN REGISTER A TRIAL TO CLINICALTRIALS.GOV featuring industry professionals who have been audited or have WITHOUT AGLOBAL POSITIONING SYSTEM AND WE’LL SHOW conducted audits of clinical trial disclosures. Attendees are invited YOU HOW !!! to come armed with their most pressing questions to pose to our Annice Bergeris Information Research Specialist, National Library of Medicine panelists on this timely and critical topic. Participants will leave this (assistance provided by Barbara Godlew and Maureen Strange) session with increased understanding and appreciation of how to prepare for, and what to expect during, a clinical disclosure audit. 10:00-10:30 AM REFRESHMENT BREAK PANELISTS 10:30 AM-12:00 PM SESSION 5 Auditee Perspective Shawn M. Pelletier HERDING CATS THROUGH CANYONS: DEVELOPING A Associate Director R&D Operations COMPANY PROCESS FOR PUBLIC DISCLOSURE Bristol-Myers Squibb Company CHAIRPERSONS Valerie V. Phillips, MA Margaret M. Cobb, MD, PhD Manager Clinical Trial Disclosure Global Leader of J & J Clinical Registry, Johnson & Johnson Pfizer Inc Pharmaceutical Research & Development, LLC Patricia Teden, MBA Auditor Perspective Independent Consultant John C. McKenney, Sr. Beat E. Widler, PhD Creating a business process that is accurate, predictable, and capable of Global Head of Clinical Quality Assurance meeting the changing needs for disclosing information about clinical trials F. Hoffmann-La Roche in multiple study registries and results databases is difficult. Companies need to leverage their current clinical trial process, determine if the disclo- sure steps will be centralized or decentralized, determine how much to 3:00-3:30 PM REFRESHMENT BREAK leverage technology, and decide whether, and how, to use outside resources. During this session, we will hear how a large pharma, a small 3:30-5:00 PM SESSION 7 biopharmaceutical company, and a device company developed their clini- cal trial disclosure business process. “EMERALDS OF EXPERIENCE” HERDING BIG PHARMA CATS … AVOIDING ACCIDENTS: CLINICAL TRIAL DISCLOSURE Margaret M. Cobb, MD, PhD LESSONS LEARNED CHAIRPERSON SMALL PHARMA: THE CATS WITH MANY HATS Anthony K. Taylor, Sr. Mary Kuskin, RPh Clinical Operations Coordinator, Targanta Therapeutics Director, Regulatory Affairs, Pharmalink Consulting Inc. Corporation The field of clinical trial disclosure has expanded dramatically in the last ten years. There has been a steady increase in the reach A DEVICE COMPANY AND COMBINATION PRODUCTS PERSPECTIVE Lisa Griffin Vincent, PhD, MA of stakeholders, regulations and experience on a global scale. The Senior Director, Corporate Clinical Research & Development, strategy for posting and maintaining clinical trial information finds a Medtronic Inc. place in the overall development and lifecycle strategy for biophar- maceutical and medical device companies. This session will highlight 12:00-1:30 PM LUNCHEON individuals’ experiences along this path to share the practical aspects of balancing regulation compliance with presentation of meaningful 1:30-3:00 PM SESSION 6 information on clinical trial databases. ARE YOU READY? PREPARING FOR AUDIT OF CLINICAL TRIAL DISCLOSURES CHAIRPERSONS 5:00 PM CONFERENCE ADJOURNED John C. McKenney, Sr. President & CEO, SEC Associates Inc. Statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice. Recording of information, in any type of media, is prohibited at all DIA events without prior written consent from DIA. 4
  • 5. “Emeralds of Experience” Information The Drug Information Association (DIA) is offering a unique opportunity for presenters at The Clinical Trial Disclosure “Emeralds of Experience” session is sched- the DIA Clinical Trial Disclosure conference in Weston, FL. uled for Wednesday, November 14, 2007 at 3:30 pm. A podium session will provide those in the clinical trial disclosure field an opportunity to Those interested in participating in the 15-minute podium presentation share their successes, challenges, and “Emeralds of Experience” on various topics with session should submit an abstract on the topic and information that their DIA Clinical Trial Disclosure colleagues. Participants can share their experiences and will be presented. Due to the limited time available for podium presen- “emeralds” by developing a 15-minute presentation. tations, only 4 (four) “Emeralds” will be accepted. A subset of the Suggested Abstract Topics: program committee will review and select from the topics submitted, if necessary. For those interested in submitting a poster, authors Stakeholder Street Maps: A Worldwide Overview to Clinical Trial Disclosure Law should submit an abstract according to the Guidelines for Abstract Reading and Following the Road Map: Public Registration of Clinical Protocol Submission below. Information After the Trial is Completed: What, When, Where, and How to Post Trial Results DEADLINE FOR SUBMISSIONS IS SEPTEMBER 17, 2007. Clinical Trial Landscape and Lifecycle: The Relationship between Registration and the Trial Publication Plan ALL ENTRIES MUST BE SUBMITTED ONLINE. Herding Cats through Canyons: Developing a Company Process for Public Disclosure http://www.diahome.org/DIAHOME/GetInvolved/ Are You Ready? Preparing for Audit of Public Disclosure Processes AbstractSubmissionLauncher.aspx Guidelines for Abstract Submission All abstracts must be received by September 17, 2007. Authors of selected abstracts 1. At time of electronic submission of abstracts, all speakers must will be notified by September 28, 2007. Please provide the following information complete the speaker disclosure section of the electronic submission using the online abstract form: form. 2. Preference will be given to submitted abstracts that address real-life PRIMARY TOPIC AREA applications and case studies. SPEAKER NAME (Degrees, job title) 3. Final PowerPoint presentation for all accepted abstracts will be due AFFILIATION (Mailing address, phone number, fax number, eMail) to DIA by October 23, 2007 to be reviewed by the committee and included in the attendee registration packet. Should you choose to PRESENTATION TITLE submit an abstract for consideration, please mark your calendars SUMMARY (approximately 2-3 sentences) suitable for inclusion in preliminary program, with this deadline. if selected 4. Final PowerPoint presentations for all accepted abstracts may have LEARNING OBJECTIVES (Please provide two learning objectives to inform the learner a company logo on slide number one. Any company logo appearing of what he/she should be able to do after attending your session. on any other slides will be removed by DIA. 5. Time allotted for individual presentations will be approximately ABSTRACT (300 words or less) 15-20 minutes. Final timing will be determined by the session chair and based on the number of presentations selected for the session. DISCLOSURE INFORMATION 6. DIA will provide complimentary conference attendance for the All speakers must disclose any significant financial interest or other relationship selected presenter. with the manufacturer(s) of any commercial product(s) and/or providers of commercial 7. Please note: Only one presenter per presentation will be allowed. services discussed in an educational presentation, as well as any discussion of Any exceptions to this policy must be discussed with the DIA office unlabeled or unapproved drugs or devices. in advance. TRAVEL AND HOTEL The most convenient airport is Fort Lauderdale/Hollywood UNITED AIRLINES & US AIRWAYS International Airport and attendees should make airline reservations as early as Save through Area Pricing and Discount Fees possible to ensure availability. The Hyatt Regency Bonaventure Conference Center and Spa is holding a block of rooms at the reduced rate below until To obtain schedule information and the best fares, call United Airlines’s October 22, 2007, for the DIA event attendees. Room availability at this rate Specialized Meeting Reservations Center at 1-800-521-4041. Make sure you is guaranteed only until this date or until the block is filled. refer to Meeting ID Number 571AK. Dedicated reservationists are on duty 7 Single $189 Double $214 days a week from 8:00 AM to 10:00 PM EST. Please contact the Conference Center by telephone at +1-954-616-1234 or This special offer applies to travel on domestic segments of all United Airlines, +1-800-233-1234 and mention the DIA event. The hotel is located at 250 United Express, PED, and United code share flights (UA*, operated by US Racquet Club Road, Weston, FL 33326, USA. Airways, US Airways Express and Air Canada). GROUP DISCOUNTS* Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA mem- bership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia. To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA. Participants with Disabilities: DIA event facilities and overnight accommodations are accessible to persons with disabilities. Services will be made available to sensory-impaired persons attending the event if requested at least 15 days prior to event. Contact the DIA office to indicate your needs. 5
  • 6. Drug Information Association www.diahome.org CLINICAL TRIAL DISCLOSURE CALL FOR ABSTRACTS “Emeralds of Experience” presentations learning the landscape and DUE BY SEPTEMBER 17 reading the roadmap 5 Co-located Events for Added Networking Opportunities! Hyatt Regency Bonaventure Conference DIA Outsourcing Summit Center and Spa, Weston, FL, USA Publication Writing and Building Partnerships PMI Pharmaceutical SIG/ DIA PM SIAC Joint Conference: The Future of NOVEMBER 13-14, 2007 | Event ID #07039 Pharmaceutical Project Management – Is a Paradigm Shift Needed? Winning Strategies for Achieving a Quality EDC Clinical Trial Process MEMBER EARLY BIRD Register by OCT. 23, 2007 SAVE $175 Register online or fax this page to +1-215-442-6199 DRUG INFORMATION ASSOCIATION 800 Enterprise Road, Suite 200 Horsham, PA 19044-3595 USA CONTACT & TABLETOP EXHIBIT INFORMATION Attendees may visit the tabletop exhibits during the event and during receptions (if applicable). Event information: Contact Ellen Diegel at the DIA office by telephone +1-215-442- 6158, fax +1-215-442-6199 or email Ellen.Diegel@diahome.org. Tabletop exhibit information: Contact Erin Gilliland, Exhibits Associate, at the DIA office by telephone +1-215-442-6149, fax +1-215-442-6199 or email Erin.Gilliland@ diahome.org. For tabletop exhibit space, please check the box below. To receive a tabletop exhibit application, please check. GROUP DISCOUNTS (not available online or on already discounted fees) Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time – no exceptions. See page 5 for complete details. Registration Fees If DIA cannot verify your membership upon receipt of registration REGISTRATION FORM Do not remove mailing label. Please return this entire page. 07039 form, you will be charged the nonmember fee. Registration fee includes refreshment breaks, PLEASE CONSIDER THIS FORM AN INVOICE luncheons, and reception (if applicable), and will be accepted by mail, fax, or online. Please check the applicable category: Academia Government Industry CSO Student (Call for registration information) MEMBER EARLY-BIRD OPPORTUNITY On or before After Available on nondiscount member fee only OCT. 23, 2007 OCT. 23, 2007 Last Name Check if part of group registration First Name M.I. Member Fee US $1165 US $1340 Degrees Dr. Mr. Ms. Join DIA now to qualify for the early-bird MEMBERSHIP member fee! www.diahome.org/en/Membership/ US $ 130 Job Title AboutMembership/AboutMembership To qualify for the early-bird discount, registration form and accompanying payment must be Company received by the date above. Does not apply to government/academia/nonprofit members. Address As required for postal delivery to your location Mail Stop Nonmember Fee US $1470 A one-year membership to DIA is available to those paying a NONMEMBER registration City State Zip/Postal Country fee. If paying a nonmember fee, please indicate if you do, or do not, want membership. email Required for confirmation I want to be a DIA member I do NOT want to be a DIA member Discount Fees MEMBER NONMEMBER* Phone Number Fax Number Required for confirmation Government (Full-time) US $ 300 US $ 430 Group Registrant #2 Last Name First Name Completed form required for each group registrant Charitable Nonprofit/Academia (Full-time) US $ 675 US $ 805 *If paying a nonmember fee, please check one box above, indicating whether you want membership. Group Registrant #3 Last Name First Name Completed form required for each group registrant CANCELLATION POLICY: On or before NOVEMBER 6, 2007 Group Registrant #4 Last Name First Name Completed form required for each group registrant Administrative fee that will be withheld from refund amount: Member or Nonmember = $200 PAYMENT OPTIONS Register online at www.diahome.org or check payment method Government or Academia or Nonprofit (Member or Nonmember) = $100 CREDIT CARD number may be faxed to: +1-215-442-6199. You may prefer to pay by check or bank transfer since Tutorial (if applicable) = $50 non-U.S. credit card payment will be subject to the currency conversion rate at the time of the charge. Cancellations must be in writing and be received by the cancellation date above. Visa MC AMEX Exp Date _______________________________________ Registrants who do not cancel by that date and do not attend will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel Card # _______________________________________________________________________________ and airline reservations. You may transfer your registration to a colleague at any time Name (printed) _________________________________________________________________________ but membership is not transferable. Please notify DIA of any such substitutions as soon Signature ____________________________________________________________________________ as possible. Substitute registrants will be responsible for nonmember fee, if applicable. CHECK drawn on a US bank payable to and mailed along with this form to: Drug Information Association Inc, P.O. Box DIA reserves the right to alter the venue, if necessary. If an event is cancelled, 95000-1240, Philadelphia, PA 19195-1240, USA. Please include a copy of this registration form to facilitate identification DIA is not responsible for any airfare, hotel or other costs incurred by registrants. of attendee. I cannot attend but please keep me informed of DIA’s future events. BANK TRANSFER When DIA completes your registration, an email will be sent to the address on the registration form with instructions on how to complete the Bank Transfer. Payment should be made in US dollars. Your name and company, (requires completion of name, postal address and email address on this form) as well as the Event I.D. # must be included on the transfer document to ensure payment to your account.