Past Event

Sentinel Initiative Public Workshop

On Tuesday, January 14, 2014, the Engelberg Center for Health Care Reform at Brookings hosted the sixth annual Sentinel Initiative Public Workshop at the Marriott at Metro Center in Washington, DC. This annual workshop brings together leading experts and interested stakeholders for a productive exchange on the development of the Sentinel Initiative. With the passage of the Food and Drug Administration Amendments Act of 2007, Congress mandated that the U.S. Food and Drug Administration (FDA) develop a national electronic system to track the safety of regulated medical products. In response to this charge, FDA launched the Sentinel Initiative in 2008. Mini-Sentinel, a pilot project of the Sentinel Initiative, utilizes electronic health care data for postmarket risk identification and analysis of medical product safety.  The development of the Mini-Sentinel pilot marks an important expansion of FDA’s surveillance capabilities, with the potential for delivering more rapid and actionable information to inform regulators, health care professionals, and patients.

This event also served as a forum for participants to discuss the use of Sentinel as a national resource to support evidence generation and a learning health care system. Specific topics that were addressed include:

  • An overview of the state of the Mini-Sentinel pilot program; 
  • Next steps for the Sentinel Initiative; 
  • Sentinel as a critical component of the emerging national health infrastructure; and 
  • Stakeholder feedback on Mini-Sentinel as a tool for evaluating drug safety. 

Dr. Janet Woodcock, the Director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, provided the morning keynote address.

Sentinel Initiative Public Workshop Part 1

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Sentinel Initiative Public Workshop Part 2

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Sentinel Initiative Public Workshop Part 3

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Sentinel Initiative Public Workshop Part 4

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Sentinel Initiative Public Workshop Part 5

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Agenda

Welcome and Overview

The Sentinel Initiative: The Next Steps

D

Janet Woodcock

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

State of Mini-Sentinel Activities

P

Richard Platt

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

S

Marsha E. Reichman

Senior Advisor and Scientific Lead for Surveillance Programs - Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administraion

D

Michael D. Nguyen

Deputy Director, Division of Epidemiology, Office of Biostatistics and Epidemiology - Center for Biologics Evaluation and Research, US Food and Drug Administration

Overview of Enhancements Underway to Mini-Sentinel

Emerging National Health Information Infrastructure

P

Richard Platt

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

E

Joe Selby

Executive Director - Patient-Centered Outcomes Research Institute

Break

P

Richard Platt

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

E

Joe Selby

Executive Director - Patient-Centered Outcomes Research Institute

Lunch

P

Richard Platt

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

E

Joe Selby

Executive Director - Patient-Centered Outcomes Research Institute

Break

P

Richard Platt

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

E

Joe Selby

Executive Director - Patient-Centered Outcomes Research Institute

Stakeholder Feedback on Mini-Sentinel as a Tool for Evaluating Drug Safety Issues that Require Regulatory Action

P

Rachel Sherman

Principal, Drug and Biological Drug Products - Greenleaf Health LLC

Closing Remarks

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