Regulatory and Clinical Affairs Certificate

The graduate certificate in regulatory and clinical affairs is designed to provide specialized education for individuals interested in developing a systematic understanding of the U.S. regulatory system for medical products. Students must complete at least 12 units (four course minimum) of course work including an introductory course in regulatory affairs. The certificate can be completed on a part-time basis but must be completed within five years.

Requirements

Introductory Course (1 course)

RSCI 511 Introduction to Medical Product Regulation Units: 3
RSCI 531 Industrial Approaches to Drug Discovery Units: 4
RSCI 532 Early Stage Drug Development Units: 3

Advanced Regulation (1 course)

Clinical Trials (1 course)

RSCI 517 Structure and Management of Clinical Trials Units: 4
RSCI 518 Writing Regulatory Drug Submissions Units: 3
RSCI 522 Introduction to Clinical Trial Design and Statistics Units: 3
RSCI 525 Introduction to Drug and Food Toxicology Units: 3
RSCI 526 Chemistry Manufacturing and Controls Units: 3

Quality Assurance and Risk Management (1 course)

RSCI 508 Quality Assurance for Drugs and Biologics Units: 3
RSCI 509 Quality Assurance, Medical Devices and Combination Products Units: 3
RSCI 515 Quality Systems and Standards Units: 3
RSCI 520 Introduction to Risk Management for Health Care Products Units: 2

Minimum Units: 12

Additional Requirements

Other courses may be substituted with the approval of the program director. The program will include course work delivered in nontraditional formats such as intensive weekend sessions and will use distance capabilities to capture and Webcast lectures and study materials. Courses can be taken on site, by distance or as a blended combination. Students should confirm their specific course work plan in consultation with the graduate advisers before beginning the program. Students who have a baccalaureate degree from an accredited college or university must submit an application for graduate study through the regulatory science program of the Mann School of Pharmacy and Pharmaceutical Sciences. GRE scores are not required for admission to the certificate program. Students are expected to enroll each semester until the program is completed and must be finished within five years.