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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
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January 31
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Planned Expansion of Prospective Surveillance Program
1:00 pm - 1:50 pm
PAPatrick Archdeacon Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationSSSebastian Schneeweiss Harvard Medical School and Brigham and Women’s Hospital -
The Sentinel Initiative: Ongoing Progress and Future Directions
9:20 am - 9:40 am
JWJanet Woodcock Director, Center for Drug Evaluation and Research - US Food and Drug Administration -
Stakeholder Feedback on Mini-Sentinel as a Tool for Evaluating Drug Safety Issues that Require Regulatory Action
2:40 pm - 3:50 pm
JWJanet Woodcock Director, Center for Drug Evaluation and Research - US Food and Drug AdministrationJSJohn Santa Consumer Reports Health Ratings CenterMWMyrl Weinberg Chief Executive Officer - National Health Council -
Opportunities to Expand the Public Health Impact of the Sentinel Initiative
1:50 pm - 2:30 pm
SNSam Nussbaum Executive Vice President, Clinical Health Policy and Chief Medical Officer - WellPoint, Inc. -
Collaborations Supporting Active Surveillance Research
11:30 am - 12:00 pm
JCNJennifer Clark Nelson Group Health Research InstituteDMDavid Madigan Columbia University -
State of Mini-Sentinel Activities
9:40 am - 10:10 am
RPRichard Platt Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute -
Selected Mini-Sentinel Protocol-Driven Evaluations
10:20 am - 11:30 am
MERMarsha 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 AdministraionMDNMichael D. Nguyen Deputy Director, Division of Epidemiology, Office of Biostatistics and Epidemiology - Center for Biologics Evaluation and Research, US Food and Drug AdministrationDTDarren Toh Harvard Pilgrim Health Care Institute and Harvard Medical SchoolMBMelissa Butler Kaiser Permanente
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