410.649 Introduction to Regulatory Affairs

Regulatory affairs (RA) comprise the rules and regulations governing product development and post-approval marketing of medical products. In the U.S., the FDA establishes and oversees the applicable regulations under several statutes, many regulations, and partnership with legislators, patients, and customers. Biotechnology products may be classified as drugs, biologics, or medical devices, foods, or combinations. Each type is regulated by a different center within the FDA. This course provides an overview of RA, its affect on product development, and how to use the rules to your advantage. Topics include: RA history, regulatory agencies, how to access regulatory information, drug submissions, biologics submissions, medical device submissions, GXP, FDA inspections, exclusivity, and regulatory strategy. Students are given case studies that allow them to apply what they have learned about regulatory affairs to "real-world" type situations.

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