FDA Postmarket Surveillance Draft Guidance and Implications for Industry
1 Hour Video | Gregory W. Daniel, Brookings Institution
In early 2015 the Brookings Institution, a nonprofit think-tank committed to independent research and innovative policy, released an article outlining a seven-year plan to develop and execute a National Medical Device Postmarket Surveillance System (MDS). The Brookings Institution was commissioned by the FDA to develop the draft proposal citing a need to replace outdated monitoring methods and provide enhanced data demonstrating the safety and benefits of medical devices. Under the proposal, opportunities and strategies for increasing the efficiency and value of postmarket evidence development to support decision-makers across health care system are outlined. A thorough understanding of these potential strategies and uses of data will provide device manufacturers with a proactive approach for managing risks and ensuring postmarket safety and compliance.
- US Device Postmarket Surveillance: Past, Present and Future
- Vision for a National Medical Device System for postmarket evidence development
- Proposal effects on other stakeholders (patients, payors, providers, etc.)
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Postmarket Surveillance
- Quality Assurance
Dr. Gregory Daniel is a Fellow in Economic Studies and Managing Director for Evidence Development and Innovation in the Center for Health Policy at Brookings. In this position, Dr. Daniel leads the Center’s pharmaceutical and medical device policy portfolio that includes developing strategies for better post-market safety surveillance and comparative effectiveness research, improving regulatory science, fostering practical steps for implementing expedited drug and device development and review tools, improving biomedical innovation, and supporting payment reform. Dr. Daniel is also a senior advisor to the Reagan-Udall Foundation for the FDA.
Prior to joining Brookings, Dr. Daniel was the Vice President of Government and Academic Research at HealthCore, Inc., a research subsidiary of Anthem, Inc. At HealthCore, he led a division responsible for research in the areas of pharmacoepidemiology, drug, vaccine, and biologic safety evaluations, comparative effectiveness research, and health economics and outcomes research. His research has utilized electronic health insurance claims data integrated with clinical data including laboratory results, electronic hospital data, paper-based and electronic medical record data, and registries. Dr. Daniel is a registered pharmacist and holds a PhD in Pharmaceutical Economics, Policy, and Outcomes with a minor in Epidemiology from the University of Arizona, an MPH specializing in biostatistics, an MS in Pharmaceutical Administration, and a BS in Pharmacy, all from The Ohio State University.
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