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Session 2 Evolving Regulatory Landscape in the EU, US and Rest of the World
Session Chair(s)
Suzette Kox, MPHARM
Senior Director International-Biosimilars Medicines Group, Medicines for Europe, Belgium
Regulatory frameworks for biosimilars are being developed around the world. During this session, the experts will look into the regulatory developments in the EU but also in other highly regulated regions and globally. Topics, such as clinical data requirements, extrapolation, interchangeability, labelling and other topics related to the evolving regulatory biosimilar landscape will be discussed.
Speaker(s)
Peter Richardson
Senior Quality Specialist, European Medicines Agency, Netherlands
European Medicines Agency Update on Biosimilars
Elena Wolff-Holz, MD, PHD
Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP; Assessor, Paul-Ehrlich Institut, Germany
EMA Biosimilar Medicines Working Party Update on Recent Developments and Experiences in the Field of Biosimilars
Steven Kozlowski, MD
Director, Office of Biotechnology Products, OPQ, CDER, FDA, United States
US FDA Regulatory Developments
Hye-Na Kang, DVM
Scientist, Access To Medicines and Health Products, World Health Organization, Switzerland
WHO Update on Recent Developments and Experiences in the Field of Biosimilars and Non-Originator Products
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