Regulatory Affairs

AAPS’ Regulatory Affairs program examines the skills, techniques and concepts required for a career in regulatory affairs. Students will become familiar with regulatory systems, legislation and practices which relate to development, quality and manufacture of pharmaceutical goods.

Students will gain knowledge on a wide range of regulations and standards including good manufacturing practices, good laboratory practices, post approval activities, regulatory compliance, the Canadian Food and Drugs Act and Global Regulatory Strategies.

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Pharma Certificate Food Certificate
Introduction to Regulatory Affairs Food Regulations
Regulatory Submissions
Chemistry, Manufacturing and Control
Regulatory Affairs Generic Drugs
Post Approval Activities and Compliance
Regulatory Affairs for Natural Health Products
Regulatory Affairs for Biologics/Biotechnology Products
Medical Devices
Global Regulatory Strategies
Labelling and Product Summaries
Introduction to Clinical Research and Drug Safety