Northeastern University College of Professional Studies
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Biopharmaceutical International Regulatory Affairs

Curriculum

REQUIRED COURSES
RGA 6220 Global Biotechnology Product Registration: EU, U.S., and Japan 4 q.h.
RGA 6221 European Union Compliance Process and Regulatory Affairs 4 q.h.

Choose two of the following

 
RGA 6228 Managing International Clinical Trials 4 q.h.
RGA 6222 Global Awareness: European Medical Device Regulations 4 q.h.
RGA 6223 Global Awareness: Canada, Asian, and Latin American Regulatory Affairs 4 q.h.
RGA 6225
Japanese Medical Device Regulations and Registrations 4 q.h.
RGA 6226 Canadian and Australian Medical Device Regulation 4 q.h.
RGA 6227
Global Awareness: Emerging Medical Device Markets 4 q.h. 
RGA 6210
Strategic Planning and Project Management for Regulatory Affairs Professionals in Domestic and International Markets  4 q.h. 
RGA 6212
Safety Sciences 1: Inroduction to Safety and Surveillance for Drugs, Biologics, and Medical Devices in the U.S. and Abroad  4 q.h. 

TOTAL QUARTER HOURS:

16 q.h.
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