RGA 6475 — Strategic Planning and Project Management for Regulatory Affairs
2 semester hoursGraduateLecture
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. Studies the function and format of presubmission meetings with U.S. and other global regulatory agencies, as well as their role in gaining regulatory approval for market sale.