Online Regulatory Affairs | Graduate Certificate Courses

Curriculum Details

12 TOTAL CREDITS REQUIRED

The Graduate Certificate in Regulatory Affairs requires successful completion of 12 credit hours. You’ll explore topics such as the development of drugs and biologics, devices and diagnostics, clinical research in regulatory affairs, and regulatory compliance.

You can complete this graduate certificate in as little as 1 year and transfer all semester credits earned this program to the MSHS in Regulatory Affairs program also offered by GW.

Required Courses (6 credits)

RAFF 6201 Introduction to Global Regulatory Affairs Credit Hours: 3

Foundations of regulatory affairs, including U.S. and international legislation and regulatory processes guidelines. Roles of leaders of regulatory affairs in developing products, navigating the regulatory review and approval process, and contributing to keeping products on the market.

RAFF 6205 Regulatory Affairs Compliance Credit Hours: 3

Analysis and evaluation of regulatory affairs compliance strategies and guidelines. Pre and post marketing compliance of medical products, oversight, labeling, advertising and use.

Select One Course (3 credits)

RAFF 6202 Regulatory Drug Biologics Credit Hours: 3

Development and evaluation of the regulatory affairs strategies that support drug and biologic development. Research science, study design, master file, risk/benefit analyses, product specifications and milestone identification, IND and NDA.

RAFF 6203 Regulatory Device Diagnostics Credit Hours: 3

Development and evaluation of the regulatory affairs strategies that support device and diagnostics development. Research science, study design, master file, risk/benefit analyses, product specifications and milestone identification, IDE, 510K, PMA.

Select One Course (3 credits)

RAFF 6204 Clinical Research for Regulatory Affairs Credit Hours: 3

The planning and conduct of clinical trials. Topics include protocol development, study design, post-marketing surveillance, and evaluation and assessment of regulatory submissions. Strategies for achieving clinical development goals.

RAFF 6206 International Regulatory Affairs Credit Hours: 3

International regulatory requirements for the development and approval of new pharmaceuticals around the world. Prerequisites: RAFF 6201.

RAFF 6207 Advertising and Promotion of Regulated Medical Products Credit Hours: 3

Exploration of FDA-regulated advertising and promotion of pharmaceutical drugs. Focus on pre- and post-market issues for prescription drugs and management of risks and compliance surrounding medical and commercial communications. Prerequisites: RAFF 6201 and RAFF 6202.

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Note, 45 transferrable credits required to apply for BSHS and BSHS/MSHS dual degree programs