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

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


The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 251
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

OCR for page 251
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

OCR for page 251
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

OCR for page 251