Past Event

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

Welcome, Overview, and Conference Objectives

D

Janet Woodcock

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

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

P

Richard Platt

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

J

Paul Stang

Johnson & Johnson and the Observational Medical Outcomes Partnership

C

Francesca Cunningham

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

Lessons Learned from Recent Mini-Sentinel Assessments

H

Jeffrey Brown

Harvard Pilgrim Health Care Institute and Harvard Medical School

W

Alec Walker

World Health Information Science Consultants, LLC

Day 1: Wrap Up

Day 2: Welcome and Overview

P

Rachel Sherman

Principal, Drug and Biological Drug Products - Greenleaf Health LLC

Supporting Industry-Sponsored Phase IV Studies

P

Richard Platt

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

J

Paul Stang

Johnson & Johnson and the Observational Medical Outcomes Partnership

Supporting Safety Science Methods Research and Development

P

Rachel Sherman

Principal, Drug and Biological Drug Products - Greenleaf Health LLC

C

Ellen Sigal

Chairperson and Founder - Friends of Cancer Research

Creating Sentinel as a National Resource for Evidence Development

U

Patrick Miller

University of New Hampshire and All-Payer Claims Database Council

E

Joe Selby

Executive Director - Patient-Centered Outcomes Research Institute

O

Rich Elmore

Office of the National Coordinator for Health Information Technology

Closing Remarks

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