EMP 6101 - Regulatory, Reimbursement and IP Considerations in Life Sciences

Credits: 2

Life Sciences are a heavily regulated industry. Virtually every aspect of product management in the life sciences involves interacting with regulated activities. This course will introduce students to the regulatory aspects of product development in life sciences, such as Quality System Regulation 21CFR Part 820 and Design Controls. It also introduces the premarket approval process with 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.Life Sciences are a heavily regulated industry. Virtually every aspect of product management in the life sciences involves interacting with regulated activities. This course will introduce students to the regulatory aspects of product development in life sciences, such as Quality System Regulation 21CFR Part 820 and Design Controls. It also introduces the premarket approval process with 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.