Pharmaceutical Regulatory Affairs Diploma Program


Duration: 28 Weeks

AAPS regulatory affairs program provides a comprehensive background and training required of regulatory affairs professionals to address domestic and international regulatory statutes and laws.

The AAPS Regulatory Affairs program includes courses on; International, Health Canada, and FDA’s laws, regulations, and Guidelines, investigational and marketing applications, technical writing, negotiation skills, development of New Drug Application (NDA) submissions, labeling and drug Information, Common Technical Documents (CTD), Notice of Compliance (NOC), Good Clinical Practices (GCPs), requirements for ongoing post-marketing surveillance and post-marketing changes, communication and management skills essential for the successful regulatory affairs professional in an industry work environment.

To register for In Class, contact us via telephone at 416-502-2277 or by email at info@aaps.ca

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Diploma Program: Please directly contact AAPS for Registration and Payment.

Individual Certificate Courses: Please see below for online availability. The online courses are registered and paid for individually.

Course Outline

Diploma in Professional Regulatory Affairs
Code Course
PRA1008/09/10 Introduction to Regulatory Affairs In Class Online
GMP1001 Introduction to Good Manufacturing Practices – Level I In Class Online
MFG1007 Introduction to Pharmaceutical Manufacturing Methods In Class Online
GMP2001 Good Manufacturing Practices – Level II In Class Online
PRA2008 Regulatory Submission In Class Online
PRA2011 Preclinical – Drug In Class Online
PRA2012 Clinical – Drug In Class Online
PRA3001 Post Approval Activities and Compliance In Class Online
TWR3009 Technical Writing and Scientific Communication In Class Online
PRA2010 Chemistry Manufacturing and Control In Class Online
PRA3006 Labeling and Product Summaries In Class Online
PRA3008 Global Regulatory Strategies In Class Online
CR010 Introduction to Clinical Research and Drug Safety In Class Online
GMP3001 Good Manufacturing Practices – Level III In Class Online
PRA2013 Generics Drug In Class Online
PRA3003 Natural Health Products In Class Online
PRA3004 Biologics/Biotechnology Products In Class Online
PRA3005 Medical Devices In Class Online

RA professionals are employed in industry, government and academia and are involved with a wide range of products, including:

  • Document Control
  • Regulatory Affairs Associate
  • Regulatory Affairs Assistant
  • Project Coordinator
  • QA Associate
  • QA Assistant
  • Manufacturing Auditor
  • Quality Auditor