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CLINICAL TRIAL DISCLOSURE Learning the Landscape and Reading the Roadmap

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CLINICAL TRIAL DISCLOSURE Learning the Landscape and Reading the Roadmap One of Five Co-located DIA Events! CLINICAL TRIAL DISCLOSURE learning the landscape and 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 President and Principal Analyst regulations for public disclosure of clinical trial information. Individuals delivering The FAIRE Company, LLC this conference work inside the industry ensuring company compliance with laws PAMELA ROSE, RN, BSN, ASQ-CMQOE and regulations governing the public disclosure of clinical trial information. Director, Clinical Trial Information Registries, TAP Pharmaceutical Products Inc. Knowledge gained from industry-driven experience cannot be overstated. PROGRAM COMMITTEE TRACY BECK, PhD This Event is Co-located with 4 other DIA Conferences Global Medical Business Office Consultant; CTR for Added Networking Opportunities! Results Gatekeeper, Eli Lilly and Company MARGARET M. COBB, MD 5 Publication Writing and Building Partnerships Global Leader of J & J Clinical Registry, DIA Outsourcing Summit Johnson & Johnson Pharmaceutical Research Co-located & Development, LLC Events PMI Pharmaceutical SIG/DIA PM SIAC Joint Conference: The Future of Pharmaceutical Project Management – Is a Paradigm Shift Needed? MARY KUSKIN, RPh Director, Regulatory Affairs Winning Strategies for Achieving a Quality EDC Clinical Trial Process: Pharmalink Consulting Inc. Sponsor/CRO, Investigator, IRB Approver and IT/IS GERARD LYNCH Global Manager, AstraZeneca Clinical Trials Website, AstraZeneca JOHN C. McKENNEY, Sr. President & CEO, SEC Associates Inc. WHO SHOULD ATTEND ROBERT PAARLBERG, MS Director, Global Regulatory Policy and Intelligence, Those who will benefit from attending this program include: UCB, Inc. Clinical trial sponsors Pharmaceutical industry and academic MICHAEL RUBISON clinical researchers Senior Director, Global Medical Research Independent investigators Clinical research and development \ and Registration, Abbott Laboratories Biotechnology researchers departments MAUREEN STRANGE Investigator site personnel Investigational review boards/ethics Associate Medical Business Operations Consultant; Regulatory affairs personnel committees CTR Initiated Gatekeeper, Eli Lilly and Company Medical communications groups Clinical quality assurance professionals PATRICIA TEDEN, MBA Independent Consultant 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 GROUP AND THE CLINICAL RESEARCH, REGULATORY AFFAIRS, AND MEDICAL WRITING SPECIAL INTEREST AREA COMMUNITIES For further information, contact Ellen Diegel, Program Manager Phone +1.215.442.6158 / Fax +1.215.442.6199 VISIT WWW.DIAHOME.ORG FOR% A COMPLETE SCHEDULE OF EVENTS [email protected] DIA, 800 Enterprise Road, Suite 200, Horsham, PA 19044, USA tel: +1-215-442-6100 fax: +1-215-442-6199 email: dia@diahom 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! with the role of the market in health care delivery, contractors MONDAY • NOVEMBER 12 as customers, and the very large amounts spent on R&D. Outsourced costs such as CRO contracts and clinical grants 4:00-6:00 PM REGISTRATION 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 play, in the entire process, as well as how the major actors 7:30-8:15 AM REGISTRATION AND involved need to interact with one another. CONTINENTAL BREAKFAST 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 Added Feature! London. Shared refreshment breaks, luncheons, and networking reception Dr. Glass holds a MSc (Econ.) from the London School of Economics and a allow for extensive multidisciplinary networking opportunities PhD from the University of North Carolina. He has served on the faculties among attendees. of the University of North Carolina and University of Zurich, and has pub- 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 OUTSOURCING pharmaceutical marketing. 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 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. 2 Program Agenda for Clinical Trial Disclosure 10:15-10:30 AM WELCOME FROM with transparency of clinical trial registration and results disclosure. PROGRAM CHAIRPERSONS This overview will include US federal and state legislation, interna- Barbara Godlew, RN tional policies and institutional agreements for both required and vol- President and Principal Analyst untary compliance, and the key issues that have driven clinical trial The FAIRE Company, LLC transparency. The international research and regulatory community Pamela Rose, RN, BSN, ASQ-CMQOE has responded with a large array of databases and database stan- Director, Clinical Trial Information Registries dards proposed by international, national, regional healthcare and TAP Pharmaceutical Products Inc. regulatory groups, pharmaceutical companies, academic institutions, professional societies, patient advocate and therapeutic specialty groups. 10:30 AM-12:00 PM SESSION 1 KEY MILESTONES AND ISSUES: A CHRONOLOGICAL HISTORY OF CLINICAL TRIAL LANDSCAPE AND LIFECYCLE: CLINICAL TRIAL DISCLOSURE THE RELATIONSHIP BETWEEN DISCLOSURE AND THE Gerard Lynch TRIAL PUBLICATION PLAN Michael Rubison, PhD CHAIRPERSONS Barbara Godlew, RN Robert Paarlberg, MS 3:00-3:30 PM REFRESHMENT BREAK Director, Global Regulatory Policy and Intelligence, UCB, Inc. The relationship between clinical trial disclosure and the publication 3:30-5:00 PM SESSION 3 plan for congress abstracts/posters and completed study manuscript are closely intertwined. This session will examine some of the aspects AFTER THE TRIAL IS COMPLETED: WHAT, WHEN, clinical teams should consider when writing a study protocol as well WHERE, AND HOW TO POST TRIAL RESULTS as identifying key stakeholders to include in the publication planning CHAIRPERSONS process.
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