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Getting to Yes from Regulators to Payers and Beyond - the Decision-Maker Gauntlet
Panel Session
Regulatory, Quality and Good Manufacturing Practices
Nicole Taylor Smith
Vice President, Global Regulatory Policy
Medtronic
Jeff Shuren, MD, JD
Director, Center for Devices and Radiological Health
Food and Drug Administration
Melissa Torres
Associate Director for International Affairs, Center for Devices and Radiological Health
FDA
John Wilkinson, MBA
Director of Devices
Medicines and Healthcare products Regulatory Agency (MHRA), U.K.
Augusto Geyer, MSc
Deputy General Manager of the Medical Devices Office
Brazilian Health Regulatory Agency – ANVISA
The complexity of the global medical device regulatory landscape continues to increase. This session will discuss recent information shared at the September International Medical Devices Regulatory Forum (IMDRF) meeting and will include panelist reflections on these timely updates. Focus will include IMDRF activities and a deep dive look at initiatives designed as building blocks for the development of a Medical Device Single Review Program (MDSRP) to ultimately enable a single regulatory pre-market review to satisfy multiple regulatory jurisdictions.
