Regulatory Management (MS)

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Regulatory management relates to the leadership of teams involved in the regulatory and legal requirements of biomedical product development to the scientific study needed to establish product safety and efficacy. The Master of Science in Regulatory Management program is designed to provide post-doctoral scientists and healthcare professionals with the knowledge and skills necessary to become leaders in regulatory and clinical research. A Masters of Science in Regulatory Management will be granted upon completion of at least 24 units of formal course work. Degree requirements include courses concerned with the regulatory aspects of medical product development, quality assurance, clinical research and business. Students should develop a specific plan of study in consultation with the graduate advisers before beginning the program.

Course Work

Students may select courses from areas within the regulatory science program, including from regulatory science, quality management, and clinical development, including that of business, human resource management, and project management. Suggested course options include but are not limited to the following:

RSCI 511 Introduction to Medical Product Regulation Units: 3
RSCI 512 Regulation of Pharmaceutical and Biological Products Units: 3
RSCI 513 Regulation of Medical Devices and Diagnostics Units: 3
RSCI 517 Structure and Management of Clinical Trials Units: 4
RSCI 590 Directed Research Units: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12