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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)
Closing Remarks
Hillel P Cohen, PhD
Retired, United States
Biosimilars Expert
Speaker
Jian Wang, MD, PhD
Health Canada, Canada
Division Manager, Clinical Review Division – Heamatology/Oncology
Speaker
Andrea Laslop, MD
Malta Medicines Authority, University of Innsbruck, Austria
Former Head of Scientific Office, AGES & Regulatory expert, lecturer
Speaker
Eva Temkin, JD
Arnold & Porter, United States
Partner
Speaker
Stacey Ricci
US FDA, United States
Director, Scientific Review Staff, OTBB, CDER