GCC - 552 Intro to Regulatory Process

Lectures cover the process of Drug and Device Discovery, the IND or IDE process, preclinical research, clinical research process for Drug and Device studies, New Drug application, international drug development guidelines, IRB in drug research, device development, reporting adverse drug reactions, the use of biologic markers in trials, drug metabolism, Genetics in Drug Development and orphan drug development, as well as PK/PD modeling in Drug Development. Retake Counts for Credit: No. Pass/No Pass Grading Allowed: No. Credit(s): 2