This course is 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. By the end of the course, participants should already feel more confident working in the field not only because they will have the resources necessary from a technical perspective, but because they will also gain a comprehensive overview of how Regulatory Affairs Professionals contribute to an organization.
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.
Who should attend?
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.
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. Stephen and his team of Regulatory Professionals support all Regions globally and they are the primary contact with the European Medicines Agency. Prior to this, Stephen 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. Stephen 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 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 Science, Economics, and Mathematics from the University of Toronto. He holds a Post-Graduate Certification in Regulatory Affairs as well as a Certification in Biotechnology & Pharmaceutical Technology. In addition, Stephen also holds an Executive Master of Business Administration degree from the Richard Ivey School of Business at the University of Western Ontario.
|Basic Ticket:||$375.00||— Sold Out|
|Student Ticket:||$187.50||— Sold Out|
|Pro Ticket:||$345.00||— Sold Out|