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Thursday January 8, 2009

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Past Event

An Engelberg Center for Health Care Reform Event

Forum on Drug Safety and Post-Market Evidence

Health Care


Event Summary

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.

Event Information

When

Friday, June 13, 2008
8:30 AM to 12:30 PM

Where

The University Club
1135 16th St, NW
Washington, DC 20036
Map

Event Materials

Contact: Brookings Office of Communications

E-mail: engelbergevents@brookings.edu

Phone: 202.797.6105

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 »
 

Transcript

Mark McClellan: ... last year Congress enacted the FDA Amendments Act which include some major provisions related to the monitoring and use of drugs after they are on the market. On top of that, FDA has been taking many new steps to enhance its surveillance-related activities. This conference focuses on some of the most important provisions and issues related to these very important topics, and in particular, building on pilot programs and expanding capabilities of our increasingly electronic health care system, Congress called for the establishment of an active surveillance system for drugs and other medical products.

Participants

Panelists and Featured Speakers

Mark B. McClellan

Director, Engelberg Center for Health Care Reform

Andrew von Eschenbach

Commissioner, FDA

Janet Woodcock

Director, Center for Drug Evaluation and Research, FDA

Marc Boutin

Executive Vice President, National Health Council

Arnold Chan

Director, i3 Aperio™, i3 Drug Safety

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

CEO, eHealth Initiative

Garry Neil

Corporate Vice President, COSAT, Johnson & Johnson

Rich Platt

Professor and Chair, Department of Ambulatory Care and Prevention, Harvard University

Kristen Rosati

Partner, Coppersmith Gordon Schermer & Brockelman PLC

Lee Rucker

AARP Public Policy Institute, AARP

Marcus Wilson

President, HealthCore


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