AAPS’ Regulatory Affairs online courses 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.
Successful candidates will also receive an online certificate per completed module:
Quality Assurance
- Good Manufacturing Practices Level I
- Good Manufacturing Practices Level II
- Good Manufacturing Practices Level III
- Introduction to Auditing Level I
- Advanced Auditing Level II
- Technical Writing and Scientific Communication
- Introduction to Pharmaceutical Manufacturing Methods
Regulatory Affairs
- Introduction to Regulatory Affairs
- Regulatory Submissions and Preclinical – Drugs
- Intellectual Property
- Chemistry, Manufacturing and Control
- Clinical – Drugs
- Generics Drug
- Post Approval Activities and Compliance
- Natural Health Products
- Biologics/Biotechnology Products
- RA Medical Devices
- Labeling and Product Summaries
- Global Regulatory Strategies
To register, enroll into any online course or contact us via telephone at 416-502-2277 or by email at info@aaps.ca.