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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)
The Regulatory Situation of Biosimilars in the EU
Elena Wolff-Holz, MD, PhD
Paul-Ehrlich Institut, Germany
Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP; Assessor
Speaker
Emily Griffiths, PhD
Health Canada, Canada
Subject Matter/Technical Specialist
Speaker
Guido Pante, PhD
World Health Organization , Switzerland
Technical Officer
Speaker
Sarah Yim, MD
FDA, United States
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER