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Past Event

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.

Read full event summary »

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

Mark McClellan is a senior fellow and director of the Health Care Innovation and Value Initiative at Brookings. He has written a number of publications on care delivery reform, physician payment reform, and accountable care implementation in the U.S. and abroad.

J

Janet Woodcock

Director, Center for Drug Evaluation and Research - US Food and Drug Administration

G

Gigi Hirsch

Executive Director, MIT Center for Biomedical Innovation

J

Judy Kramer

Executive Director of the Clinical Trials Transformation Initiative, Duke University

S

Sharon Levine

Associate Executive Medical Director, Kaiser Permanente

R

Rich Platt

Harvard Medical School and Harvard Pilgrim Health Care Institute

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