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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)
European Medicines Agency Update on Biosimilars
Dr. Peter Richardson, PHD
European Medicines Agency, Netherlands
Head of Quality, Specialised Scientific Disciplines Department
EMA Biosimilar Medicines Working Party Update on Recent Developments and Experiences in the Field of Biosimilars
Elena Wolff-Holz, MD, PHD
Paul-Ehrlich Institut, Germany
Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP; Assessor
US FDA Regulatory Developments
Steven Kozlowski, MD
FDA, United States
Director, Office of Biotechnology Products, OPQ, CDER
WHO Update on Recent Developments and Experiences in the Field of Biosimilars and Non-Originator Products
Hye-Na Kang, DVM
Access To Medicines and Health Products, World Health Organization, Switzerland
Scientist