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
Patrick Archdeacon
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Sebastian Schneeweiss
Harvard Medical School and Brigham and Women’s Hospital
The Sentinel Initiative: Ongoing Progress and Future Directions
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
Janet Woodcock
Director, Center for Drug Evaluation and Research - US Food and Drug Administration
John Santa
Consumer Reports Health Ratings Center
Myrl Weinberg
Chief Executive Officer - National Health Council
Closing Remarks
Opportunities to Expand the Public Health Impact of the Sentinel Initiative
Sam Nussbaum
Executive Vice President, Clinical Health Policy and Chief Medical Officer - WellPoint, Inc.
Collaborations Supporting Active Surveillance Research
Jennifer Clark Nelson
Group Health Research Institute
David Madigan
Columbia University
State of Mini-Sentinel Activities
Richard Platt
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Selected Mini-Sentinel Protocol-Driven Evaluations
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
Michael D. Nguyen
Deputy Director, Division of Epidemiology, Office of Biostatistics and Epidemiology - Center for Biologics Evaluation and Research, US Food and Drug Administration
Darren Toh
Harvard Pilgrim Health Care Institute and Harvard Medical School
Melissa Butler
Kaiser Permanente
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