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FDA Sentinel Initiative Strategic Review

    Event Information
    Event Type

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

    Mark McClellan MD, PhD; Engelberg Center for Health Care Reform, Brooking Institution, Washington, DC

    Janet Woodcock MD; U.S. Food and Drug Administration, Silver Spring, MD


    Rachel Sherman MD, MPH; Robb Melissa RN; U.S. Food and Drug Administration, Silver Spring, MD

    Richard Platt MD, MSc; Brown Jeffrey PhD; Department of Population Medicine, Harvard Pilgrim Healthcare Research Institute and Harvard Medical School, Boston, MA

    Marcus Wilson PharmD; HealthCore, Wilmington, DE

    Brian Kelly MD, MBA; Aetna, Hartford, CT

    Arnold Chan ScD, MD; Optuminsight Life Sciences, Waltham, MA