Sep 26

Past Event

FDA Sentinel Initiative Strategic Review

Event Materials

Summary

Three years ago, the U.S. Food and Drug Administration (FDA) launched the Sentinel Initiative, making significant progress in developing a system for conducting active surveillance of medical products.  On September 26-27, the Engelberg Center hosted an event to reflect on the progress of the Initiative to date, and to consider its future direction and sustainability.

This event brought together a diverse set of stakeholders to reflect on the progress of the Initiative made to date, and consider its future direction to ensure sustainability of the system and reliability of results generated, including:

  • Potential pathways that others outside of FDA (e.g., industry, academic safety scientists, etc) can access the resources and tools developed through the Mini-Sentinel pilot;

  • Alignment of national priorities for safety science methods research and development, and training opportunities for the next generation of safety scientists; and

  • Development of a national resource for evidence development by identifying synergies with related initiatives

Details

September 26-27, 2011

The Brookings Institution

Falk Auditorium

1775 Massachusetts Ave., NW

Map

For More Information

Engelberg Events

202.797.4391

Event Agenda

  • Welcome, Overview, and Conference Objectives

    • mmclellanimage

      Mark B. McClellan

      Director

      Economic Studies

    • Janet Woodcock

      U.S. Food and Drug Administration

  • Perspectives on the Progress of the Sentinel Initiative: Protecting Public Health

    • Richard Platt

      Harvard Pilgrim Health Care Institute and Harvard Medical School

    • Paul Stang

      Johnson & Johnson and the Observational Medical Outcomes Partnership

    • Fran Cunningham

      Department of Veterans Affairs

    • Marcus Wilson

      HealthCore

    • Michael McCaughan

      Prevision Policy LLC and The RPM Report

  • Lessons Learned from Recent Mini-Sentinel Assessments

    • Melissa Robb

      U.S. Food and Drug Administration

    • Jeffrey Brown

      Harvard Pilgrim Health Care Institute and Harvard Medical School

    • Alec Walker

      World Health Information Science Consultants, LLC

    • Brian J. Kelly

      Aetna

  • Day 1: Wrap Up

    • mmclellanimage

      Mark B. McClellan

      Director

      Economic Studies

  • Day 2: Welcome and Overview

    • mmclellanimage

      Mark B. McClellan

      Director

      Economic Studies

    • Rachel Sherman

      U.S. Food and Drug Administration

  • Supporting Industry-Sponsored Phase IV Studies

    • Nancy Santanello

      Merck & Co. Inc.

    • Briggs Morrison

      Pfizer Inc.

    • Elliott Levy

      Bristol Myers Squibb

    • Richard Platt

      Harvard Pilgrim Health Care Institute and Harvard Medical School

    • Paul Stang

      Johnson & Johnson and the Observational Medical Outcomes Partnership

    • Arnold Chan

      OptumInsight Life Sciences

    • John Santa

      Consumer Reports Health Ratings Center

  • Supporting Safety Science Methods Research and Development

    • Rachel Sherman

      U.S. Food and Drug Administration

    • Garry Neil

      Johnson & Johnson and Board Member of the Reagan Udall Foundation

    • Ronald Krall

      University of Pennsylvania Center for Bioethics

    • Ellen Sigal

      Friends of Cancer Research

    • Ralph Horwitz

      GlaxoSmithKline

  • Creating Sentinel as a National Resource for Evidence Development

    • mmclellanimage

      Mark B. McClellan

      Director

      Economic Studies

    • Patrick Miller

      University of New Hampshire and All-Payer Claims Database Council

    • Dave Knutson

      U.S. Department of Health and Human Services

    • Joe Selby

      Patient-Centered Outcomes Research Institute

    • Rich Elmore

      Office of the National Coordinator for Health Information Technology

    • Sean Tunis

      Center for Medical Technology Policy

  • Closing Remarks

    • mmclellanimage

      Mark B. McClellan

      Director

      Economic Studies