Forum on Drug Safety and Post-Market Evidence
On June 13, 2008, the Engelberg Center for Health Care Reform hosted a public forum on prescription drug safety and post-market evidence. This public event included a brief overview of current Food and Drug Administration (FDA) activity concerning drug safety; a discussion of a broad-based approach to generating a distributed data network for post-market evidence; and a review of progress to date on a host of technical, legal, and communications-related challenges identified in the course of our ongoing collaborative work in this area.
Mark McClellan, Director of the Engelberg Center for Health Care Reform and Leonard D. Schaeffer Chair in Health Policy Studies at the Brookings Institution, provided introductory remarks and helped moderate this discussion among many of today’s leading health care policy-makers and analysts.
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Meeting Materials:
Agenda »
Panelists’ Slide Presentations »
Drug Safety Collaboration Legal Guidance Document »
Sentinel Project Handout »
Agenda
Forum on Drug Safety and Post-Market Evidence
The Engelberg Center for Health Care Reform hosted a public forum on prescription drug safety that included a brief overview of current Food and Drug Administration activity as well as progress to date on a host of technical, legal and communications-related challenges identified in the course of the center’s ongoing collaborative work in this area.
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Andrew von Eschenbach
Commissioner, FDA
Janet Woodcock
Director, Center for Drug Evaluation and Research - US Food and Drug Administration
Arnold Chan
OptumInsight Life Sciences
Gigi Hirsch
Executive Director, MIT Center for Biomedical Innovation
Judy Kramer
Executive Director of the Clinical Trials Transformation Initiative, Duke University
Sharon Levine
Associate Executive Medical Director, Kaiser Permanente
Janet Marchibroda
Chair, Health Information Technology Initiative
Garry Neil
Johnson & Johnson
Rich Platt
Harvard Medical School and Harvard Pilgrim Health Care Institute
Kristen B. Rosati
Coppersmith Schermer & Brockelman PLC
Lee Rucker
AARP Public Policy Institute, AARP
Marcus D. Wilson
President - HealthCore
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