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Past Event

Sentinel Initiative Public Workshop

On January 31, the Engelberg Center for Health Care Reform hosted the fifth annual Sentinel Initiative public workshop, at the Washington Marriott Wardman Park in Washington, DC. This public workshop brought together the members of various stakeholder communities for a productive discussion on the continuing development of active medical product surveillance, including:

  • The State of Mini-Sentinel Activities
  • Selected Mini-Sentinel Protocol-Driven Evaluations
  • Collaborations Supporting Active Surveillance Research
  • Planned Expansion of Prospective Surveillance Programs
  • Opportunities to Expand the Public Health Impact of the Sentinel Initiative
  • Stakeholder Feedback on Mini-Sentinel as a Tool for Evaluating Drug Safety Issues that Require Regulatory Action

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. Both Dr. Woodcock and Dr. Karen Midthun, the Director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration participated in a panel seeking input on the ongoing progress as well as the future of the Sentinel Initiative.

Event Video:

Agenda

Planned Expansion of Prospective Surveillance Program

P

Patrick Archdeacon

Center for Drug Evaluation and Research, U.S. Food and Drug Administration

The Sentinel Initiative: Ongoing Progress and Future Directions

J

Janet Woodcock

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

Welcome and Overview

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

J

Janet Woodcock

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

Closing Remarks

Opportunities to Expand the Public Health Impact of the Sentinel Initiative

S

Sam Nussbaum

Executive Vice President, Clinical Health Policy and Chief Medical Officer - WellPoint, Inc.

Collaborations Supporting Active Surveillance Research

State of Mini-Sentinel Activities

R

Richard Platt

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

Selected Mini-Sentinel Protocol-Driven Evaluations

M

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

M

Michael D. Nguyen

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

D

Darren Toh

Harvard Pilgrim Health Care Institute and Harvard Medical School

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