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Session 9: Regulatory Landscape – Ask the Regulators and Closing Remarks
Session Chair(s)
Sarah Yim, MD
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER, FDA, United States
This session focuses on the regulator’s perspective and provides an opportunity for interactive Q&A. The session will begin with brief presentations of the highlights of recent regulatory developments from the mentioned regulators, followed by a panel question and answer session.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe recent biosimilar-related regulatory developments in the participating speakers’ countries
- Better interpret the regulatory perspective on biosimilar-related development in the participating countries
- Better answer biosimilar-related development questions from a regulatory perspective
Speaker(s)
Hillel P Cohen, PHD
Biosimilars Expert, Retired, United States
Closing Remarks
Jian Wang, MD, PHD
Division Manager, Clinical Review Division – Heamatology/Oncology, Health Canada, Canada
Speaker
Andrea Laslop, MD
Former Head of Scientific Office, AGES & Regulatory expert, lecturer, Malta Medicines Authority, University of Innsbruck, Austria
Speaker
Eva Temkin, LLM
Partner, Arnold & Porter, United States
Speaker
Stacey Ricci, DRSC
Director, Scientific Review Staff, OTBB, CDER, FDA, United States
Speaker
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