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Session 10: Regulatory Developments/Ask the Regulator
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 Q&A 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
- Interpret the regulatory perspective on biosimilar-related development in the participating countries
- Understand biosimilar-related development questions from a regulatory perspective
Speaker(s)
Elena Wolff-Holz, MD, PHD
Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP; Assessor, Paul-Ehrlich Institut, Germany
The Regulatory Situation of Biosimilars in the EU
Emily Griffiths, PHD
Subject Matter/Technical Specialist, Health Canada, Canada
Speaker
Guido Pante, PHD
Technical Officer, World Health Organization , Switzerland
Speaker
Sarah Yim, MD
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER, FDA, United States
Speaker
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