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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.

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