Regulatory Affairs

Catalog description

This introductory course emphasizes the terminology and basic concepts of the pharmaceutical regulation by the Food and Drug Administration, as it applies to drugs, medical devices, and biological and veterinary product development. The course will include discussion of data submission requirements, quality procedure regulations, marketing considerations. Practical exercises will be representative of tasks assigned to employees seeking entry level positions within the industry. For students pursuing the Bachelor of Applied Science (BAS) Degree only: Offered all terms. Prerequisite(s): CLNR 363 & CLNR 364 When Offered: Fall. Lecture/Lab Lecture