Regulatory Affairs (RAFF)

Explanation of Course Numbers

  • Courses in the 1000s are primarily introductory undergraduate courses
  • Those in the 2000s to 4000s are upper-division undergraduate courses that can also be taken for graduate credit with permission and additional work
  • Those in the 6000s and 8000s are for master’s, doctoral, and professional-level students
  • The 6000s are open to advanced undergraduate students with approval of the instructor and the dean or advising office

RAFF 6201. Introduction to Global Regulatory Affairs. 3 Credits.

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 6202. Regulatory Drug Biologics. 3 Credits.

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. 3 Credits.

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.

RAFF 6204. Clinical Research for Regulatory Affairs. 3 Credits.

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 6205. Regulatory Affairs Compliance. 3 Credits.

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

RAFF 6275. Leadership in Regulatory Affairs. 3 Credits.

Theories of leadership and change are integrated in the development of change proposals for the regulatory affairs field. The development of leadership solutions to problems in leading regulatory strategic change; integration of all field course work into implementation plans for health care system changes.