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Oct 25

Past Event

Understanding and Discussing the Implications of FDA's Sentinel Initiative

 

Event Materials

Summary

On October 25, the Engelberg Center hosted and expert workshop, "Understanding and Discussing the Implications of FDA's Sentinel Initiative," which focused on issues of importance for medical product developers.

This meeting brought together representatives to discuss the role of FDA’s pilot program, Mini-Sentinel, within FDA’s broader array of tools to monitor medical product safety and to discuss mechanisms for how developers could support and engage with FDA on Sentinel-related activities.

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Event Agenda

  • Panel

  • Sentinel's Progress: Past, Present, and Future

    • Melissa Robb

      U.S. Food and Drug Administration

  • Mini Sentinel's Current Active Surveillance Capabilities

    • Rich Platt

      Harvard Medical School and Harvard Pilgrim Health Care Institute

  • Stakeholder Roles in Sentinel

    • Rachel Sherman

      U.S. Food and Drug Administration

  • Proposed Role of Medical Product Developers in the Execution of Safety Surveillance Activities

    • Briggs Morrison

      Pfizer Inc.

  • Proposal for Medical Product Developers to Support Safety Science Methods Research and Development

    • Elliott Levy

      Bristol-Myers Squibb

    • Garry Neil

      Johnson and Johnson

  • Remarks from the Director of FDA's Center for Drug Evaluation and Research

    • Janet Woodcock

      U.S. Food and Drug Administration

  • Closing Remarks and Adjournment

Details

October 25, 2011

10:00 AM - 2:00 PM EDT

Grand Hyatt Washington

Constitution Ballroom

1000 H Street NW

Map

For More Information

Engelberg Events

202.797.4391

SERIES: Expert Workshops | Number 9