FDA Sentinel Initiative Strategic Review

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

Agenda

Former Brookings Expert

Director, Margolis Center for Health Policy - Duke University

Director, Center for Drug Evaluation and Research - US Food and Drug Administration

Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute

Johnson & Johnson and the Observational Medical Outcomes Partnership

Center for Medication Safety PSCI, Department of Veterans Affairs National Center for Patient Safety and Pharmacy Benefits Management Services

President - HealthCore

Prevision Policy LLC and The RPM Report

U.S. Food and Drug Administration

Harvard Pilgrim Health Care Institute and Harvard Medical School

World Health Information Science Consultants, LLC

Aetna

Former Brookings Expert

Director, Margolis Center for Health Policy - Duke University

Former Brookings Expert

Director, Margolis Center for Health Policy - Duke University

Principal, Drug and Biological Drug Products - Greenleaf Health LLC

Vice President and Head of Epidemiology

Bristol-Myers Squibb

Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute

Johnson & Johnson and the Observational Medical Outcomes Partnership

OptumInsight Life Sciences

Consumer Reports Health Ratings Center

Principal, Drug and Biological Drug Products - Greenleaf Health LLC

Johnson & Johnson

University of Pennsylvania Center for Bioethics

Chairperson and Founder - Friends of Cancer Research

Former Brookings Expert

Director, Margolis Center for Health Policy - Duke University

University of New Hampshire and All-Payer Claims Database Council

U.S. Department of Health and Human Services

Executive Director - Patient-Centered Outcomes Research Institute

Office of the National Coordinator for Health Information Technology

Former Brookings Expert

Director, Margolis Center for Health Policy - Duke University

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