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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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