The Master of Science (MS) in Regulatory Science provides graduates with the knowledge and skills necessary to contribute to drug and biologics regulation and pharmaceutical product lifecycles.
Applications for this exclusively online program are now being accepted, until July 15, 2016. Fall semester begins August 22, 2016.
What is Regulatory Science?
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 diagnostics, devices, and nutritional products are also addressed. The program covers 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 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.
Who Should Apply to the Master of Science (MS) in Regulatory Science Program?
This online program is primarily designed for working professionals with Bachelor of Science (BS) degrees who now work in (or would like to work in) regulatory science in industry or government. Working professionals include regulatory affairs associates, scientists in research or development, and clinical associates in clinical affairs or marketed-product support.
What Will I Learn in the Master of Science (MS) in Regulatory Science Program?
Graduates of this 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
With the knowledge and skills obtained through this program, graduates will have access to a number of opportunities in drug and biologics research and development, including but not limited to:
- 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
How Do I Know if this Online Program is Right for Me?
This part-time, online program is designed for working professionals who would like to obtain a formal degree in regulatory science. Such individuals include CMC and development professionals, clinical associates, public health professionals, post-marketing and safety associates, and discovery scientists. The program primarily focuses on drugs and biologics.
Each of the program's six-credit courses consists of about 70 hours of pre-recorded lectures, seven hours of live web conferencing, and 13 hours of active-learning instruction. In addition, there are individual projects, as well as team presentations and mini-reviews. Taking into account instruction time and project requirements, we estimate a time commitment of one day per week during fall and spring semesters. For the summer semester, we estimate a time commitment of approximately two days a week.
What if I am More Interested in Devices Than Drugs and Biologics?
Please visit the website for the Graduate Certificate in Engineering (GCEN) for Regulatory Science and Engineering at the University of Maryland, College Park.
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