University of Maryland Graduate School

Program Overview

According to the Food and Drug Administration (FDA), regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.

The MS in Regulatory Science program at the University of Maryland School of Pharmacy primarily focuses on drugs and biologics, although aspects of biologics, diagnostics, devices, and nutritional products are also addressed. The program covers all major areas of drug product regulatory science, including: Chemistry, Manufacturing, and Controls (CMC), Clinical Research, Pharmacovigilance, Phase IV Research (e.g., Pharmacoepidemiology), and Drug Discovery. The strength of the program is its science-driven understanding of drug product development and regulation. The program covers regulatory affairs in a global manner, including the application of regulatory principles worldwide.