Summary

On January 31, the Engelberg Center for Health Care Reform hosted the fifth annual Sentinel Initiative public workshop, at the Washington Marriott Wardman Park in Washington, DC. This public workshop brought together the members of various stakeholder communities for a productive discussion on the continuing development of active medical product surveillance, including:

  • The State of Mini-Sentinel Activities
  • Selected Mini-Sentinel Protocol-Driven Evaluations
  • Collaborations Supporting Active Surveillance Research
  • Planned Expansion of Prospective Surveillance Programs
  • Opportunities to Expand the Public Health Impact of the Sentinel Initiative
  • Stakeholder Feedback on Mini-Sentinel as a Tool for Evaluating Drug Safety Issues that Require Regulatory Action

Dr. Janet Woodcock, the Director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, provided the morning keynote address. Both Dr. Woodcock and Dr. Karen Midthun, the Director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration participated in a panel seeking input on the ongoing progress as well as the future of the Sentinel Initiative.

Event Video:

Event Agenda

  • 9:00 - 9:20

    Welcome and Overview

  • 9:20 - 9:40

    The Sentinel Initiative: Ongoing Progress and Future Directions

    • Janet Woodcock

      Center for Drug Evaluation and Research, U.S. Food and Drug Administration

  • 9:40 - 10:10

    State of Mini-Sentinel Activities

    • Richard Platt

      Harvard Pilgrim Health Care Institute and Harvard Medical School

  • 10:20 - 11:30

    Selected Mini-Sentinel Protocol-Driven Evaluations

    • Moderator

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    • Marsha Reichman

      Center for Drug Evaluation and Research, U.S. Food and Drug Administration

    • Michael Nguyen

      Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

    • Darren Toh

      Harvard Pilgrim Health Care Institute and Harvard Medical School

    • Melissa Butler

      Kaiser Permanente

    • Katherine Yih

      Harvard Pilgrim Health Care Institute and Harvard Medical School

  • 11:30 - 12:00

    Collaborations Supporting Active Surveillance Research

  • 1:00 - 1:50

    Planned Expansion of Prospective Surveillance Program

    • Moderator

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    • Patrick Archdeacon

      Center for Drug Evaluation and Research, U.S. Food and Drug Administration

    • Elizabeth Chrischilles

      University of Iowa

    • Sebastian Schneeweiss

      Harvard Medical School and Brigham and Women’s Hospital

    • Katherine Yih

      Harvard Pilgrim Health Care Institute and Harvard Medical School

  • 1:50 - 2:30

    Opportunities to Expand the Public Health Impact of the Sentinel Initiative

  • 2:40 - 3:50

    Stakeholder Feedback on Mini-Sentinel as a Tool for Evaluating Drug Safety Issues that Require Regulatory Action

    • Moderator

      mmclellanimage
    • Karen Midthun

      Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

    • Janet Woodcock

      Center for Drug Evaluation and Research, U.S. Food and Drug Administration

    • John Santa

      Consumer Reports Health Ratings Center

    • Myrl Weinberg

      National Health Council

    • Ralph Horwitz

      GlaxoSmithKline

  • 3:50 - 4:00

    Closing Remarks

Details

January 31, 2013

9:00 AM - 4:00 PM EST

Marriott Wardman Park

2660 Woodley Road, NW

Map

For More Information

Engelberg Events

202.797.4391

SERIES: Public Workshops | Number 6