Northeastern University College of Professional Studies
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Biopharmaceutical Domestic Regulatory Affairs

Curriculum

REQUIRED COURSES
RGA 6200Biologics Development: A QA/Regulatory Overview4 q.h.
RGA 6201New Drug Development: A QA/Regulatory Overview4 q.h.
RGA 6202Medical Device Development: A QA/Regulatory Overview4 q.h.
   
Choose one of the following:
RGA 6203Food, Drug, and Medical Device Law: Topics and Cases4 q.h.
RGA 6206Practical Aspects of Regulatory Compliance
4 q.h.
RGA 6210Strategic Planning and Project Management for Regulatory Affairs Professionals in Domestic and International Markets
4 q.h.
RGA 6211Combination Products and Convergence
4 q.h.
RGA 6212
Safety Sciences 1: Introduction to Safety and Surveillance for Drugs, Biologics, and Medical Devises in the U.S. and Abroad 4 q.h.
RGA 6214Food and Drug Administration: Creation, Behavior, and Regulatory Culture
4 q.h.
RGA 6216Medical, Social, and Financial Dimensions of Orphan Drugs 4 q.h.
RGA NEWFrom Biotech to Bedside and Back Again4 q.h.
TCC 6370Regulatory Writing: Medical Device Submissions
4 q.h.
TCC 6380Regulatory Writing: New Drug Applications 4 q.h.
   
TOTAL QUARTER HOURS
16 q.h. 
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