Center for Professional Innovation & Education (CfPIE), Los Angeles, CA
Mar. 5 & 6, 2012
This course will be most valuable to medical device/product professionals who need a firm understanding of how to gain FDA approval for combination products. Upon completion of this course, attendees will have an understanding of the framework for the specific FDA Combination Product regulations required to speed these therapies to market. The course will also provide an overview of medical device, drug, and biologic product regulations to the extent that they relate to combination products. Emphasis will be placed not only on the regulatory aspects of product development, but also on overall medical product strategy and the development environment. Instructional emphasis is focused on taking an efficient, cost-effective approach to obtaining FDA approval, thus avoiding unnecessary costs and wasted time.
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