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Session 6: Taking the International Pulse: What’s New in the Policy and Regulatory Landscape?
Session Chair(s)
Suzette Kox, MPharm
Senior Director International-Biosimilars Medicines Group
Medicines for Europe, Belgium
In this session, international regulators from the European Union, Japan, Canada, and the World Health Organization will provide an overview of recent and future policy and regulatory developments in their country/region in the field of biosimilar medicines. An update on lessons learned over the years of existence of the biosimilar pathway will set the scene for what’s coming next and how experience will be factored in regulatory science to shape future evolutions in the biosimilar medicines field in terms of local/regional guidance and its implementation. The impact of international information exchange and collaboration platforms (bilateral and multi-lateral) will also be examined.
Learning Objective :
Speaker(s)
Speaker
Ivana Knezevic
World Health Organization, Switzerland
Technical Standards and Specifications Unit (TSS)
Speaker
Cathy A. Parker
Health Canada, Canada
Director General, Biologics & Genetic Therapies Directorate HPFB
Speaker
Kyoko Sakurai, PharmD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of Cellular and Tissue-Based Products
Speaker
Leon van Aerts, PhD
Medicines Evaluation Board, The Netherlands, Netherlands
Speaker
Leah Christl, PhD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy