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Regulatory Considerations in Life Sciences (EMP 6101)

April 29, 2024

This course will introduce students to the regulatory aspects of product development in life sciences, such as Quality System Regulation 21 CFR Part 820 and Design Controls. It also introduces the premarket approval process with the FDA, including 510K, PMA, etc. Also addressed are the regulatory aspects of marketing claims, including evidence-based claims, approved indications and off-label usage. The arcane process of reimbursement (getting paid) for life sciences products is also introduced. Also covered are the unique aspects of intellectual property (IP) in life sciences. Credits: 2