Wednesday, October 9 12:15 - 1:15 pm in Petrus 1 and 2
VIVA 13 represents the continued insights and collaboration from the United States Food and Drug Administration and the Centers for Medicare and Medicaid Services in our “Regulatory and Coverage Consortium.” In keeping with the tradition of highlighting emerging technologies and challenges from the perspective of our colleagues in the FDA and CMS, VIVA will focus on opportunities and advances. This year, with the expanded involvement of our international colleagues, leading representatives from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) will join us once again. We will compare and contrast regulatory policies and practices and highlight how collaboration has led the way to novel trials, which may result in multinational device approval. Opinions on approaches to drug/device combination products, renal denervation, and device-based management of venous thromboembolic disease will be discussed.
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Michael R. Jaff, DO |
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