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


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