The Future of Drug Safety Promoting and Protecting the Health of the Public (2007) / Chapter Skim
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Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas
Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas
Pages 255-266
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Steen Galson Acting Director of the Center for Drug Evaluation and Research Food and Drug Administration
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Perspectives Daid Borenstein Member, Board of Directors American College of Rheumatology (ACR)
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APPENDIX D Questions from the Committee 12:45–1:00 p.m. Adjourn 1:00 p.m.
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Wednesday, July 20, 2005 OPEN SESSION LECTURE ROOM Welcome and Introductions 1:00–1:05 p.m. Daid Blumenthal Sheila Burke Co-Chairs, Committee on the Assessment of the US Drug Safety System Food and Drug Administration's (FDA's)
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Trontell Deputy Director, Office of Drug Safety FDA Center for Drugs Food and Drug Administration Future of Safety Assessment Paul J Seligman Questions from the Committee 3:00–3:30 p.m.
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0 THE FUTURE OF DRUG SAFETY Questions from the Committee 5:15–5:45 p.m. Adjourn 5:45 p.m.
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APPENDIX D Assessing Risks and Benefits of Pharmaceuticals: Methods and Approaches Brian Strom, MD, MPH Chair and Professor Department of Biostatistics and Epidemiology University of Pennsylvania Premarket Assessment of Drug Safety at the FDA Judith Racoosin, MD, MPH Safety Team Leader Division of Neurology Products Division of Psychiatry Products Center for Drug Evaluation and Research U.S. Food and Drug Administration FDA Postapproval Risk Assessment Anne Trontell, MD, MPH Senior Advisor on Pharmaceutical Outcomes Center for Outcomes and Evidence Agency for Healthcare Policy and Research Risk-Benefit Frameworks: Perspectives from the Field of Environmental Health Jonathan Samet, MD, MS Professor and Chair Department of Epidemiology Johns Hopkins School of Public Health Discussion: Q & A with IOM Committee Members 9:45 a.m.
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THE FUTURE OF DRUG SAFETY Presentation of Case Study 1 -- Salmeterol Scott T Weiss, MD Professor of Medicine Harvard Medical School Presentation of Case Study 2 -- Muraglitazar Steve Nissen, MD Medical Director, Cardiovascular Coordinating Center Cleveland Clinic Questions of Clarification of Fact Lunch 12:30 p.m.
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APPENDIX D Noel Weiss, MD, PhD Professor of Epidemiology, School of Public Health and Community Medicine, University of Washington Discussion: Q & A with IOM Committee Members and Audience Break 3:00 p.m. Establishing a framework for risk-benefit methods to 3:30 p.m.
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THE FUTURE OF DRUG SAFETY MEETING FOUR -- AGENDA The National Academies Institute of Medicine Committee on the Assessment of the US Drug Safety System AGENDA Thursday, January 19, 2006 OPEN SESSION Keck 100 Welcome and Introductions 8:15–8:25 a.m. Description of Committee's request to inited speakers Many recommendations for strengthening FDA's role in drug safety have been made in the past several years.
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APPENDIX D 8:25–8:45 a.m. Geoffrey Levitt Wyeth Pharmaceuticals 8:45–9:05 a.m.
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