Fundamentals of Medical Product Development and Regulation

3 units · Graduate

Function of clinical research in medical product development and the regulatory process of new medical products. Laws and regulations concerning the development, testing, commercialization, and total product life cycle for medical products. Regulations governing the conduct of clinical research, including study sponsors, investigators, and Institutional Review Boards. Prereq: Enrollment in Master of Clinical Research program, or enrollment in Clinical Research Management certificate, or permission of instructor.