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Summary

In May 2008, the U.S. Food and Drug Administration (FDA) unveiled the Sentinel Initiative – a national electronic data system designed to track the safety of drugs, biologics, and medical devices in the United States. Since that time, FDA has engaged key stakeholders to address technical and policy issues that are critical to the initiative’s success.

On January 12, the Engelberg Center for Health Care Reform hosted the third annual Sentinel Initiative public workshop, bringing together the stakeholder community for a discussion on a variety of topics in active medical product surveillance, including an update on Mini-Sentinel, the testing mechanism and coordinating center for the Sentinel Initiative; near-term plans for the Sentinel Initiative; and opportunities for coordination with other Department of Health and Human Services efforts that use distributed systems of automated health care data.

Read The New England Journal of Medicine article, "Developing the Sentinel System – A National Resource for Evidence Development."

Event Agenda

  • 9:00 AM -- Welcome

    • mmclellanimage

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Janet Woodcock

      Director, Center for Drug Evaluation and Research

      U.S. Food and Drug Administration

  • 9:10 AM -- Keynote Address

  • 9:40 AM -- Sentinel Today: FDA Perspective

    • Rachel Behrman

      Director, Office of Medical Policy, Center for Drug Evaluation and Research

      U.S. Food and Drug Administration

    • Judy Racoosin

      Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research

      U.S. Food and Drug Administration

  • 10:00 AM -- Session I: Mini-Sentinel Accomplishments and Plans for Year Two

    • Moderator

      mmclellanimage

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Richard Platt

      Professor and Chair, Department of Population Medicine,

      Harvard Medical School and Harvard Pilgrim Health Care Institute

    • Lesley H. Curtis

      Associate Professor

      Duke University School of Medicine

    • Kristen Rosati

      Partner, Coppersmith Schermer & Brockelman PLC

    • Bruce Fireman

      Biostatistician and Research Scientist

      Kaiser Permanente, Northern California

  • 1:15 PM -- Session II: Perspectives from the Stakeholder Community

    • Moderator

      mmclellanimage

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Kathleen Jaeger

      Vice President and Chief Executive Officer

      National Community Pharmacists Association

    • Myrl Weinberg

      President, National Health Council

    • Diana Zuckerman

      President, National Research Center for Women & Families

    • Dan Troy

      Senior Vice President and General Counsel

      GlaxoSmithKline

    • J. Leonard Lichtenfeld

      Deputy Chief Medical Officer, American Cancer Society

  • 3:00 PM -- Session III: Sentinel as a National Resource for Evidence Development

    • Moderator

      mmclellanimage

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Janet Woodcock

      Director, Center for Drug Evaluation and Research

      U.S. Food and Drug Administration

    • Sherry Glied

      Assistant Secretary for Planning and Evaluation

      U.S. Department of Health and Human Services

    • David Blumenthal

      National Coordinator for Health Information Technology

      U.S. Department of Health and Human Services

    • Reed Tuckson

      Executive Vice President and Chief of Medical Affairs

      UnitedHealth Group

    • Sam Nussbaum

      Executive Vice President, Clinical Health Policy and Chief Medical Officer

      Wellpoint, Inc.

  • 4:30 PM -- Closing Remarks

Details

January 12, 2011

8:30 AM - 4:30 PM EST

Renaissance Dupont Circle Hotel

New Hampshire Ballroom

1143 New Hampshire Ave. NW

Map

For More Information

Engelberg Center for Health Care Reform

(202)797-4391

SERIES: Public Workshops | Number 4