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Ethical and Scientific Issues in Studying the Safety of Approved Drugs (2012) / Chapter Skim
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Appendix C: Open Session Agendas
Pages 251-254

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From page 251...
... 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 Health12:00 PM care Research and Quality (AHRQ)
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From page 252...
... Goodman, Co-Chairs Panel A -- Interpreting Safety Signals in the Context of Regu9:00 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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From page 253...
... 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.
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Key Terms

  • keck center
  • deputy commissioner
  • joshua sharfstein
  • jesse berlin
  • population medicine

  • latory science
  • executive vice
  • principal deputy
  • pharmaceutical research
  • medical officer

  • health council
  • safety signals
  • johnson pharmaceutical
  • session welcome
  • janet woodcock

  • fda representatives
  • associate dean
  • harvard pilgrim
  • pfizer inc
  • marc boutin

  • committee introductions
  • scientific issues
  • pilgrim health
  • chief medical
  • ing officer

  • vice president
  • drugs keck
  • fifth street
  • panel questions
  • fda dr


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