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Opening Remarks Remarks and Session 5: Biosimilar Regulatory Developments: Stay in the Loop!
Session Chair(s)
Denis Arsenault, MBA
Manager, Policy Development, Biologic and Radiopharmaceutical Drugs Directorate,, Health Canada, Canada
The regulatory landscape for biosimilars is rapidly evolving. This session will provide participants an opportunity to hear directly from regulatory bodies across the world on the latest developments in their respective jurisdictions regarding the regulation of biosimilars. Presenters will provide an overview of new and planned regulatory initiatives and related activities. These overviews will be followed by an interactive question & answer session allowing participants to dig deeper into key issues of interest.
Learning Objective :
- Describe key biosimilar-related regulatory developments and initiatives in participating jurisdictions
- Apply these insights in developing and adjusting plans for regulatory consultations
- Prepare and adjust product development plans in light of the evolving regulatory landscape
Speaker(s)
Denis Arsenault, MBA
Manager, Policy Development, Biologic and Radiopharmaceutical Drugs Directorate,, Health Canada, Canada
Regulatory Authorization of Biosimilars in Canada: Latest Developments
Sarah Yim, MD
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER, FDA, United States
Biosimilar and Interchangeable Products in the United States: Regulatory Update
Pascal Crottet, DRSC
Quality Assessor, Division Quality Assessment, Sector Authorisation, Swissmedic, Switzerland
Procedures for Biosimilar Applications in Switzerland
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