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
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.
In Class Registration Process
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