PHTX 634

Introduction to Medical Product Regulatory Affairs

This is a Graduate level course that will familiarize students with basic concepts of regulatory compliance during drug, biologic, and medical device development. Basic concepts to be taught are: 1. Product development life-cycles, focusing on phases of development and stages for interactions with regulatory agencies; 2. Quality control and assurance in the laboratory, manufacturer, and clinic the basis of good practices; 3. Familiarization with FDA guidance documents, ICH guidelines, and the code of federal regulations. Upon completion of the course, students should have an understanding of the relationship between regulators, drug or device developers (bench scientists and clinicians), manufacturers, and patients

Units: 1.0