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.

The Graduate Certificate consists of the first two courses of the MS program, for a total of 12 credits. It can be completed in less than one year, and is designed for students who seek a more limited course of study or commitment than the MS degree, which requires less than two years and 30 credits to complete. Certificate students can apply for the MS program at a later date, if desired, and apply their completed courses towards the MS degree.