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Hilton Arlington Towers

Sep 20, 2022 7:00 AM - Sep 21, 2022 3:00 PM

950 N Stafford St., Arlington, VA 22203-1813, USA

Biosimilars Conference

Convening Professionals in Biosimilar Development to Discuss the Challenges of Today and the Possibilities of Tomorrow

Opening Remarks Remarks and Session 5: Biosimilar Regulatory Developments: Stay in the Loop!

Session Chair(s)

Denis  Arsenault, MBA

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)

Denis  Arsenault, MBA

Regulatory Authorization of Biosimilars in Canada: Latest Developments

Denis Arsenault, MBA

Health Canada, Canada

Manager, Policy Development, Health Products and Food Branch, Biologic and

Sarah  Yim, MD

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

Pascal  Crottet, DrSc

Procedures for Biosimilar Applications in Switzerland

Pascal Crottet, DrSc

Swissmedic, Switzerland

Quality Assessor, Division Quality Assessment, Sector Authorisation

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