Regulatory Affairs

Certificate Program Overview

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
• Generic Drugs
• Post Approval Activities and Compliance
• Natural Health Products
• Biologics/Biotechnological Products
• RA Medical Devices
• Global Regulatory Strategies
• Labelling and Product Summaries

Certifications

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:

• Introduction to Regulatory Affairs
• Regulatory Submissions and Preclinical – Drugs
• Chemistry, Manufacturing and Control
• Generic Drugs
• Post Approval Activities and Compliance
• Natural Health Products
• Biologics/Biotechnological Products
• RA Medical Devices
• Global Regulatory Strategies
• Labelling and Product Summaries

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

• In Class Registration Process