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Mar 1

Past Event

Expert Workshop: Patient and Consumer Engagement in FDA’s Sentinel Initiative

Summary

The U.S. Food and Drug Administration’s Sentinel Initiative has made important strides towards developing a valuable tool that can actively monitor the safety of medical products. Productive and broad collaboration among stakeholders from public and private institutions has been instrumental to this success. Since the Initiative’s inception, patient and consumer organizations have provided valuable perspectives and input into Sentinel.

On March 1, the Engelberg Center hosted an expert workshop, “Patients and Consumer Engagement in FDA’s Sentinel Initiative,” to explore opportunities for further engagement of these stakeholders in the Sentinel Initiative. This meeting brought together representatives from patient and consumer advocacy organizations and FDA to do the following:

  • Provide patients and consumers with an overview of the Sentinel Initiative;
  • Discuss opportunities for further patient and consumer engagement; and
  • Discuss concrete next steps for evolving patient and consumer engagement.

Event Agenda

  • Welcome and Overview

  • Sentinel: Past, Present, and Future

    • Rachel Sherman

      U.S. Food and Drug Administration

  • Overview of the Mini-Sentinel Pilot

    • Richard Platt

      Harvard Medical School and Harvard Pilgrim Health Care Institute

  • Moderated Question and Answer

  • Facilitating Patient and Consumer Engagement

    • Moderator

      mmclellanimage

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Bray Patrick-Lake

      PFO Research Foundation and Mini-Sentinel Planning Board

    • Myrl Weinberg

      National Health Council

    • Diana Zuckerman

      National Research Center for Women & Families/Cancer Prevention and Treatment Fund

    • Lisa McGiffert

      Consumers Union

    • James Valentine

      U.S. Food and Drug Administration

  • Furthering Initiatives for Patient and Consumer Engagement

    • Moderator

      mmclellanimage

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Rachel Sherman

      U.S. Food and Drug Administration

    • Richard Platt

      Harvard Medical School and Harvard Pilgrim Health Care Institute

    • Bray Patrick-Lake

      PFO Research Foundation and Mini-Sentinel Planning Board

    • Lawrence Bachorik

      U.S. Food and Drug Administration

  • Closing Remarks and Adjournment

Details

March 1, 2012

9:00 AM - 2:00 PM EST

The Brookings Institution

Falk Auditorium

1775 Massachusetts Ave., NW

Map

For More Information

Engelberg Events

202.797.4391

SERIES: Expert Workshops | Number 10