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C Open Session Agendas First Meeting of the Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs Keck Center, 500 Fifth Street NW, Room 100 Washington, DC Monday, June 7, 2010 OPEN SESSION Welcome and Introductions 11:00 AM Ruth R. Faden, Ph.D., M.P.H., Co-Chair Steven N. Goodman, M.D., Ph.D., Co-Chair Presentation of Charge, Food and Drug Administration 11:10 AM (FDA) Dr. Margaret A. Hamburg, M.D., Commissioner, FDA Dr. Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA Committee Charge—Perspective of the Agency for Health- 12:00 PM care Research and Quality (AHRQ) Dr. Carolyn M. Clancy, M.D., Director, AHRQ Committee Charge—Perspective of the National Institutes 12:15 PM of Health (NIH) Francis S. Collins, M.D., Ph.D., Director, NIH 251
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252 STUDYING THE SAFETY OF APPROVED DRUGS Open Microphone 12:30 PM Closing Remarks 1:25 PM Ruth R. Faden, Ph.D., M.P.H., Co-Chair Steven N. Goodman, M.D., Ph.D., Co-Chair Adjourn Open Session 1:30 PM Third Meeting of the Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs Keck Center, 500 Fifth Street NW, Room 110 Washington, DC Tuesday, November 9, 2010 OPEN SESSION Welcome and Committee Introductions 8:50 AM Ruth R. Faden and Steven N. Goodman, Co-Chairs Panel A—Interpreting Safety Signals in the Context of Regu- 9:00 AM latory Science 9:00 AM Freda Lewis-Hall, M.D., FAPA, Senior Vice President and Chief Medical Officer, Pfizer Inc. 9:20 AM Susan Ellenberg, Ph.D., Professor of Biostatistics and Associate Dean for Clinical Research, University of Pennsylvania School of Medicine Panel Questions 9:40 AM 10:00 AM Break Panel B—Emerging Data Sources and Methods for 10:10 AM Pharmacovigilence 10:10 AM Jesse Berlin, Ph.D., Vice President, Pharmacoepidemiol- ogy, Johnson & Johnson Pharmaceutical Research and Development 10:30 AM Richard Platt, M.D., M.Sc., Professor and Chair, Depart- ment of Population Medicine, Harvard Pilgrim Health
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253 APPENDIX C Care Institute and Harvard Medical School. Principal Investigator of the FDA Mini-Sentinel Project and a member of OMOP Executive Board 10:50 AM Andrew Bate, Ph.D., Senior Director, Analytics Team Lead, Epidemiology, Worldwide Safety Strategy (for- merly with the WHO Collaborating Centre for Interna- tional Drug Monitoring, Uppsala Monitoring Centre) 11:10 AM Dan O’Connor, Ph.D., Greenwall Foundation Postdoc- toral Fellow in Bioethics and the History of Medicine, Berman Institute of Bioethics and the Institute for the History of Medicine, Johns Hopkins University, Balti- more, MD Panel Questions 11:20 AM 11:45 AM Break Panel C—Patient and Public Interest Group Perspective 12:00 PM Sydney Wolfe, M.D., Director of the Health Research Group, Public Citizen’s Health Marc Boutin, J.D., Executive Vice President and Chief Operat- ing Officer, The National Health Council. 12:30 PM Lunch FDA Representatives 1:15 PM Joshua Sharfstein, M.D., Principal Deputy Commissioner, FDA Dr. Janet Woodcock, M.D., Director, Center for Drug Evalua- tion and Research, FDA Adjourn Open Session 2:30 PM
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