May 4, 2020 - July 6, 2020

Training Series - Fundamentals in Regulatory Affairs

Anne Tomalin, Vice President of Quality, Regulatory and Safety will train on the Fundamentals of Regulatory Affairs in Canada providing an overview of getting approval, and maintaining that approval post-NOC, for pharmaceutical products.

This course is relevant for Regulatory personnel who would like a broad overview, or those new to Regulatory Affairs.  Portions of the course would be of interest to New Business Development, Marketing, Quality Assurance or Pharmacovigilance personnel. Medical Devices specific training will be offered in a future course. 


Training Sessions

Each session is $200, or SAVE 20% by signing up for the series.

May 4, 2020 (11:00 AM - 12:30 PM EST) 

  • Overview of Health Canada
  • Overview of ICH

May 11, 2020 (11:00 AM - 12:30 PM EST)

  • Clinical Trial Applications
  • Canadian Good Clinical Practice Regulations and Guidelines

May 19, 2020 (11:00 AM - 12:30 PM EST)

  • New Drug Submissions
  • Abbreviated New Drug Submissions
  • Priority Review and Conditional Notices of Compliance

May 25, 2020 (11:00 AM - 12:30 PM EST)

  • Biologics
  • Biosimilars

June 1, 2020 (11:00 AM - 12:30 PM EST)

  • Approval Times
  • Exclusivity and Patent Extension
  • Cost for Review
  • Appeals

June 8, 2020 (11:00 AM - 12:30 PM EST)

  • Case Study:  Biologic
  • Case Study:  Vaccine
  • Case Study:  Cell & Gene Therapy

June 15, 2020 (11:00 AM - 12:30 PM EST)

  • DIN Applications
  • Natural Health Products

June 22, 2020 (11:00 AM - 12:30 PM EST)

  • Post-NOC Changes
  • Recalls

June 29, 2020 (11:00 AM - 12:30 PM EST)

  • Advertising
  • Labelling

July 6, 2020 (11:00 AM - 12:30 PM EST)

  • Postmarketing Pharmacovigilance
  • Risk Management Plans