Graduate Certificate Biopharmaceutical Domestic
Regulatory Affairs Online

Required Courses (16 q.h.)

RGA 6200 Biologics Development: A QA/Regulatory Overview 4 q.h.
RGA 6201 New Drug Development: A QA/Regulatory Overview 4 q.h.
RGA 6202 Medical Device Development: A QA/Regulatory Overview 4 q.h.

Choose one of the following courses: 

RGA 6203 Food, Drug, and Medical Device Law: Topics and Cases 4 q.h.
RGA 6206 Practical Aspects of Regulatory Compliance 4 q.h.
RGA 6210 Strategic Planning and Project Management for Regulatory Affairs Professionals in Domestic and International Markets 4 q.h.
RGA 6211 Combination Products and Convergence 4 q.h.
RGA 6212 Safety Sciences 1: Introduction to Safety and Surveillance for Drugs, Biologics, and Medical Devices in the U.S. and Abroad 4 q.h.
RGA 6214 Food and Drug Administration: Creation, Behavior, and Regulatory Culture 4 q.h.
RGA 6216 Medical, Social, and Financial Dimensions of Orphan Drugs 4 q.h.
RGA 6217 Biomedical Product Development: From Biotech to Boardroom to Market 4 q.h.
TCC 6370 Regulatory Writing: Medical Device Submissions 4 q.h.
TCC 6380 Regulatory Writing: New Drug Applications 4 q.h.

 

Total Quarter Hours: 16


Quick Info

  • 16 Quarter Hours
  • $9,776.00 total tuition (*)
  • Full-time years to completion: 1 year
    Part-time years to completion: 1.5 years
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