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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, Health Products and Food Branch, Biologic and
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)
Regulatory Authorization of Biosimilars in Canada: Latest Developments
Denis Arsenault, MBA
Health Canada, Canada
Manager, Policy Development, Health Products and Food Branch, Biologic and
Biosimilar and Interchangeable Products in the United States: Regulatory Update
Sarah Yim, MD
FDA, United States
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER
Procedures for Biosimilar Applications in Switzerland
Pascal Crottet, DrSc
Swissmedic, Switzerland
Quality Assessor, Division Quality Assessment, Sector Authorisation