| Project Title | Sentinel Initiative Public Workshop - Eighth Annual |
| Date | Tuesday, February 2, 2016 |
| Description | The Duke-Margolis Center for Health Policy hosted the 8th Annual Sentinel Initiative Public Workshop at the Renaissance Washington, DC Dupont Circle Hotel. This annual workshop serves as a forum to bring together leading experts and interested stakeholders to discuss 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. Since 2008, Mini-Sentinel has continued to develop with great interest from the stakeholder community and recently transitioned from pilot project to the full Sentinel System to help expand and enhance the FDA’s surveillance capabilities. Specific topics that were addressed during the workshop include:
Funding for this conference was made possible in part by a cooperative agreement from the Food and Drug Administration, Center for Drug Evaluation Research. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government. The workshop was captured on video and the segments displayed below are as follows: Part 1: Welcome and Overview; Keynote Address; The Sentinel Initiative: Perspective from FDA’s Leadership; State of Sentinel Safety Surveillance Activities Part 2: Selected Sentinel Medical Product Evaluations; Current and Future Development of the Sentinel System Part 3: Developing a National Resource for Evidence Generation Part 4: Stakeholder Perspectives on Opportunities to Enhance and Modernize Postmarket Drug Safety Surveillance; Closing Remarks |
| Host | Mark McClellan MD, PhD; Duke-Robert J. Margolis Center for Health Policy, and Robert J. Margolis Professor of Business, Medicine and Health Policy, Duke University, Durham NC Greg Daniel PhD, MPH; Duke-Robert J. Margolis Center for Health Policy Washington DC and Clinical Professor, Fuqua School of Business, Duke University, Durham NC |
| Location | |
| Presenters | Steven Anderson PhD, MPP; Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration Kathleen Blake MD, MPH; Vice President, Performance Improvement, American Medical Association Jeffrey Brown PhD; Associate Professor, Department of Population Medicine, Harvard Pilgrim Healthcare Institute and Harvard Medical School Patrizia A. Cavazzoni MD; Worldwide Development Operations, Pfizer, Inc. Francesca Cunningham PharmD; Center for Medication Safety, U.S. Department of Veterans Affairs Gerald J. Dal Pan MD, MHS; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Bruce Fireman ; Division of Research, Kaiser Permanente Northern California Susan Hariri PhD; Division of Viral Hepatitis, U.S. Centers for Disease Control and Prevention Troy McCall PhD; Chief Implementation Officer, Reagan-Udall Foundation for the FDA Catherine M. Meyers MD; Office of Clinical and Regulatory Affairs, National Center for Complementary and Integrative Health, National Institutes of Health Mikita J. Stephen JD; Planning Board Member, Sentinel, Lead, Sentinel Engagement Partners Workgroup, Patient Representative, Duke Clinical Trials Transformation Initiative; Gregroy Pappas MD, PhD; National Device Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration Doris Peter PhD; Health Ratings Center, Consumer Reports Richard Platt MD, MSc; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School Marsha E. Reichman PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Melissa Robb ; Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Joe Selby MD, MPH; Patient-Centered Outcomes Research Institute; Azadeh Shoaibi PhD, MHS; Sentinel Lead, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration Paul Wallace MD; Optum Labs Janet Woodcock MD; Center for Drug Evaluation and Research, U.S. Food and Drug Administration |
| Event Type | Workshop |
