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
Successful candidates will also receive certificate 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.
1-855-502-2288
