Suggested Citation:"Appendix C: Open Session Agendas." Institute of Medicine. 2012. Ethical and Scientific Issues in Studying the Safety of Approved Drugs. Washington, DC: The National Academies Press. doi: 10.17226/13219.
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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
| 11:00 AM | Welcome and Introductions Ruth R. Faden, Ph.D., M.P.H., Co-Chair Steven N. Goodman, M.D., Ph.D., Co-Chair | |
| 11:10 AM | Presentation of Charge, Food and Drug Administration (FDA) Dr. Margaret A. Hamburg, M.D., Commissioner, FDA Dr. Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA | |
| 12:00 PM | Committee Charge—Perspective of the Agency for Health-care Research and Quality (AHRQ) Dr. Carolyn M. Clancy, M.D., Director, AHRQ | |
| 12:15 PM | Committee Charge—Perspective of the National Institutes of Health (NIH) Francis S. Collins, M.D., Ph.D., Director, NIH | |
Suggested Citation:"Appendix C: Open Session Agendas." Institute of Medicine. 2012. Ethical and Scientific Issues in Studying the Safety of Approved Drugs. Washington, DC: The National Academies Press. doi: 10.17226/13219.
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| 12:30 PM | Open Microphone | |
| 1:25 PM | Closing Remarks Ruth R. Faden, Ph.D., M.P.H., Co-Chair Steven N. Goodman, M.D., Ph.D., Co-Chair | |
| 1:30 PM | Adjourn Open Session | |
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
| 8:50 AM | Welcome and Committee Introductions Ruth R. Faden and Steven N. Goodman, Co-Chairs | |
| 9:00 AM | Panel A—Interpreting Safety Signals in the Context of Regulatory 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 | |
| 9:40 AM | Panel Questions | |
| 10:00 AM | Break | |
| 10:10 AM | Panel B—Emerging Data Sources and Methods for Pharmacovigilence | |
| 10:10 AM | Jesse Berlin, Ph.D., Vice President, Pharmacoepidemiology, Johnson & Johnson Pharmaceutical Research and Development | |
| 10:30 AM | Richard Platt, M.D., M.Sc., Professor and Chair, Department of Population Medicine, Harvard Pilgrim Health | |
Suggested Citation:"Appendix C: Open Session Agendas." Institute of Medicine. 2012. Ethical and Scientific Issues in Studying the Safety of Approved Drugs. Washington, DC: The National Academies Press. doi: 10.17226/13219.
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| 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 (formerly with the WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre) | |
| 11:10 AM | Dan O’Connor, Ph.D., Greenwall Foundation Postdoctoral Fellow in Bioethics and the History of Medicine, Berman Institute of Bioethics and the Institute for the History of Medicine, Johns Hopkins University, Baltimore, MD | |
| 11:20 AM | Panel Questions | |
| 11:45 AM | Break | |
| 12:00 PM | Panel C—Patient and Public Interest Group Perspective Sydney Wolfe, M.D., Director of the Health Research Group, Public Citizen’s Health Marc Boutin, J.D., Executive Vice President and Chief Operating Officer, The National Health Council. | |
| 12:30 PM | Lunch | |
| 1:15 PM | FDA Representatives Joshua Sharfstein, M.D., Principal Deputy Commissioner, FDA Dr. Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA | |
| 2:30 PM | Adjourn Open Session | |
