Introduction to Regulatory Affairs

3 Units

This introductory course explores government oversight of devices and drugs, and the laws and regulations that apply to their development, testing and production. This course also examines the context in which regulations evolved; the structure of the FDA and its relationship with other regulatory agencies. Class topics will include preclinical, clinical, regulatory, and marketing factors which influence commercialization of new medical products. Through lectures and class discussions, students will gain insight on clearance pathways for medical devices, drugs, and combination products, the understanding of which leads to the delivery of safe and effective healthcare products, including post-marketing surveillance. It is expected that the knowledge gained from the course will be useful in allowing students to position various individual research projects into the broader context of product development, regulatory approval and eventual market access. Prereq: Graduate standing.