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 regulatory submissions, post-approval activities, regulatory compliance, the Canadian Food and Drugs Act and Global Regulatory Strategies.
The program focuses on topics delivered through 10 modules:
Introduction to Regulatory Affairs
Regulatory Submissions and Preclinical – Drugs
Chemistry, Manufacturing and Control
Post Approval Activities and Compliance
Natural Health Products
RA Medical Devices
Global Regulatory Strategies
Labelling and Product Summaries
Upon completion, you will receive a Certificate on Professional Regulatory Affairs that is approved by the Ministry of Colleges and Universities.
Successful candidates will also receive certificates per completed module: