Applications for the Fall 2020 semester of the online Master of Science and Graduate Certificate in Regulatory Science programs are now closed.
Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of products regulated by the Food and Drug Administration (FDA). The Master of Science (MS) and Graduate Certificate in Regulatory Science programs focus on drugs and biologics, although aspects of diagnostics, devices, and nutritional products are also addressed. The Graduate Certificate in Regulatory Science provides a more limited course of study than the MS degree program.
Watch this two-minute video to learn more about the MS in Regulatory Science program, including thoughts from current students and recent graduates.
Both programs cover all major areas of drug product and biologics regulatory science, including:
- Chemistry, Manufacturing, and Controls (CMC)
- Clinical Research
- Phase IV Research (e.g., Pharmacoepidemiology)
- Drug and Biologics Discovery
The strength of the MS program is its science-driven approach to drug and biologic product development and regulation. The program covers regulatory affairs in a global manner, including the application of regulatory principles worldwide. The program is not limited to regulatory affairs, and features lectures and student activities that span the discovery of drugs/biologics to post-market activities, with a scientific emphasis on development pathways, including common challenges and science-based solutions.
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.
Graduates of the MS in Regulatory Science program will be fluent in the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products
They will possess the knowledge and skills needed to:
- Devise and implement global strategies for drug, biologic, and device development and evaluation
- Differentiate USA and other regional requirements for drug product and biologics development and registration
- Apply principles of basic and applied pharmaceutical sciences in drug and biologics discovery and development
- Formulate critical elements of CMC to drug development
- Relate principles of clinical research design to practices in clinical trial management
- Apply critical methods of risk assessment and drug utilization from pharmacoepidemiology and post-marketing surveillance, and evaluate economic and sociodemographic factors that influence drug use
The program has provided me with the opportunity to develop a greater understanding of regulatory science, which is essential to my work as an administrator for the protection of human subjects in research. The curriculum has provided a rich educational experience that challenges me to improve my research and decision-making skills. The program is truly designed to be as rigorous as a traditional in-person master’s degree program.Terrence Clemmons
With the knowledge and skills obtained through the MS in Regulatory Science program, graduates will have access to a number of opportunities in drug and biologics research and development.
- Regulatory science/affairs positions at pharmaceutical companies, as well as device and biotechnology companies
- Regulatory science/affairs positions at government agencies, such as the Food and Drug Administration (FDA), National Institutes of Health (NIH), Department of Defense, Biomedical Advanced Research and Development Authority, and the Centers for Disease Control (CDC)
- Admission into PhD programs