Two-Part Course on The Essentials of Canadian Regulatory Affairs

  • Day 1October 30, 2017
    9:00 am - 4:00 pm
  • Day 2October 31, 2017
    9:00 am - 4:00 pm


4646 Dufferin St. Unit 6, Toronto, Ontario, Canada, M3H 5S4

Certification Areas

This course is a two-part series designed to provide participants with the essential tools to effectively work in Canadian Regulatory Affairs.  The focus of the series is on prescription pharmaceuticals, biologics, and an introduction to medical devices.


DAY 1 – Essentials of Regulatory Affairs: Introductory Course

This course is designed to introduce participants to facets of Canadian Regulatory Affairs.  By the end of the course, participants should gain a general overview of how Regulatory Affairs Professionals contribute to an organization.

Key points will include:

– Introduction to the basic regulatory framework.

– Essential tools which would enable the participant to effectively work in Regulatory Affairs.

– Brief discussions on

* the drug development process

* the Canadian Food and Drugs Act

*basic parts of the Canadian Food & Drug Regulations

*important Health Canada Guidance Documents


This course is aimed at introducing Regulatory Affairs to individuals who are new to the profession and the industry (0-3 years) such that they can build a solid foundation for their career while at the same time learning various valuable tools to enable them to be confident on the job



DAY 2 – Essentials of Regulatory Affairs: Advanced Course

This course builds on the introductory course previously offered, and will extend the discussion on broader Regulatory Affairs topics such as patent and data protection, generics, and subsequent entry biologics. More importantly, this course will be more practical with emphasis on regulatory strategies and how one contributes to the overall business of the company.

Key points will include:

– Essential tools to effectively work in Canadian Regulatory Affairs

– Prescription pharmaceuticals

– Biologics

– Introduction to medical devices


This course is aimed at individuals who have worked in Regulatory Affairs for about 3-5 years and would like to take their capabilities to the next level. This course is designed to explore more advanced topics in Regulatory Affairs and how to develop value-added regulatory strategies while ensuring compliance.

SPEAKER: Stephen Li, B.Sc, MBA, CerRAP

Stephen Li is currently the Senior Director, Head of Global Regulatory Marketed Products at EMD Serono (Merck KGaA of Darmstadt, Germany) where he is responsible for the Company’s entire marketed product and medical devices Regulatory portfolios.  He and his team of Regulatory Professionals support all regions globally.  Prior to this, Mr. Li was the Head of Canadian Regulatory Affairs at EMD Inc., Canada within the Department of Scientific Affairs where he was responsible for the operation and the achievements of all objectives pertaining to Regulatory Affairs in the Canadian subsidiary.


Mr. Li has written several publications in areas such as Regulatory Affairs in clinical trials and economics within the healthcare industry focusing on research and development.  He was also a Professor and a member of the Advisory Committee in the Regulatory Affairs Program at Humber College Institute of Technology & Advanced Learning, where he taught the core Regulatory courses of the program.  Stephen graduated with Honours in the studies of Life Sciences, Economics, and Mathematics from University of Toronto.  He holds a Post-Graduate Certification in Regulatory Affairs as well as a Certification in Biotechnology & Pharmaceutical Technology.  In addition, Mr. Li also holds an Executive Master of Business Administration Degree from the Ivey Business School at Western University.


Single Day Non-Member Ticket: $525.00 On Sale
Single Day Pro/Pro Plus Member Ticket: $495.00 On Sale
2 Day Non-Member Ticket: $890.00 On Sale
2 Day Pro/Pro Plus Member Ticket: $840.00 On Sale