- February 28, 2017
6:00 am - 8:00 am
This webinar is designed to introduce participants to facets of Canadian Regulatory Affairs. By the end of the webinar, participants should gain a general overview of how Regulatory Affairs Professionals contribute to an organization. Please stay tuned for Part 2 of this webinar which will provide a more advanced discussion of RA and will extend the discussion on broader Regulatory Affairs topics such as patent and data protection, generics, and subsequent entry biologics.
- 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
Who should attend?
This webinar 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.
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 Member:||$300.00||— Sold Out|
|Basic Member Group Tickets:||$200.00||— Sold Out|
|Student Ticket:||$250.00||— Sold Out|
|Pro Ticket:||$150.00||— Sold Out|
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