Bench to Bedside to Market: FDA Regulation of Medical Devices

OHSRP Education Series Drs. Bill Prichard and Jonathan Green will be conducting this presentation. Dr. Green is the Director of OHSRP, and Dr. Prichard, a radiologist by training, is a Medical Officer in the Center for Interventional Oncology at the NIH Clinical Center. Prior to his arrival here in 2016, Dr. Prichard was a Medical Officer for 21 years at the FDA ’ s Center for Devices and Radiological Health. He has considerable regulatory expertise including preclinical study design, review of clinical trial and marketing applications, and resolution of post-market regulatory and safety issues for a wide range of medical devices. He has published two articles on device regulation and has been a regular speaker on the topic in the academic and professional community. He routinely advises intramural scientists and extramural stakeholders on methods and approaches to bringing products from bench evaluation to clinical trials and achieving marketing approval. While at the FDA, he jointly led the Laboratory of Cardiovascular and Interventional Therapeutics. Across his time at the FDA and continuing at the NIH, he has a strong history of collaborative work with government, academic and industry clinicians and scientists across a range of disciplines aimed at developing preclinical models of disease and intervention and advancing image-guided techniques and therapies for translation into clinical use. Topics that the presenters will cover include:• Device development processâ€...
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