Strategic Planning and Project Management for Regulatory Affairs

RGA 6210 4 Quarter Hours
Course Level Graduate
Description Introduces the core concepts of strategic planning and project management. Seeks to equip regulatory professionals with the skills needed to join upper corporate management in choosing which products to pursue and how best to pursue them. Offers students an opportunity to learn how to guide medical device teams through the design and development stages. Emphasizes the role of product classifications in demonstrating the safety, efficacy, and performance of medical devices for human use. The curriculum and assignments offer a chance to carefully study the function and format of presubmission meetings with U.S. and other global regulatory agencies, as well as understand their role in gaining regulatory approval for market sale. Prereq. RGA 6202, RGA 6220, or PJM 6000.

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