Degree Offered
MS, Post-Baccalaureate Certificate
Program Description
The Master of Science in Regulatory Science is designed to provide graduates with the knowledge and skills necessary to contribute to drug regulation and pharmaceutical product life cycles. The program primarily focuses on drugs, although aspects of biologics, diagnostics, devices, and nutritional products also are 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)
- 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. 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 products regulated by the U.S. Food and Drug Administration. They will possess the knowledge and skills needed to:
- Devise and implement global strategies for drug, biologic, and device development and evaluation.
- Differentiate U.S. and other regional requirements for drug product development and registration.
- Apply principles of basic and applied pharmaceutical sciences in drug 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 postmarketing surveillance, and evaluate economic and sociodemographic factors that influence drug use.
This is an online program designed for working professionals who would like to obtain a formal degree in regulatory science. The program primarily focuses on drugs and drug development. Each of the program’s 6-credit courses consists of about 70 hours of prerecorded lectures, seven hours of live web conferencing, and 13 hours of active-learning instruction. In addition, there are individual projects, team presentations, and mini-reviews.
Post-Baccalaureate Certificate
The Post-Baccalaureate Certificate (PBC) requires successful completion of the first two six-credit courses (i.e. 12 credits total) of the MS degree program, with the aim of completion in two semesters. The course are PHAR 603 Drug, Biologic, and Device and Regulation (6 credits) and PHAR 614 Drug and Biologics Discovery (6 credits). By completing these two courses, students will understand critical steps in the development and approval of drugs, biologics, and devices; and b) know approaches to discover new drugs. Students would also be well suited to subsequently complete the MS in Regulatory Science credential.
Program Admissions
Candidates for admission must meet the minimum qualifications and standards established by the Graduate School. Graduate Record Examinations scores are not required for admission if the applicant has five years or more of related work experience. International students must provide current, official results of the Test of English as a Foreign Language (minimum score of 550 for the paper-based test, 80 for the internet-based test) or the International English Language Testing System exam (minimum Band 7). Application deadlines and required credentials are regularly published by the Graduate School and the Regulatory Science program.
Degree Requirements
The master’s degree program requires a minimum of 30 credits. Students must maintain a minimum cumulative grade-point average of 3.0 to remain in good standing in the program. A complete description of progression guidelines and degree requirements is provided in the Degree Requirements section of this catalog.
Required Courses