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Session 4: International Regulator Updates
Session Chair(s)
Emer Cooke, MBA, MSC
Chair, ICMRA; Executive Director
European Medicines Agency, Netherlands
Biosimilar medicines are developed with worldwide ambitions for marketing authorisation holders. Most countries have now implemented a biosimilar medicines framework. This session will provide an update from 4 different regulatory bodies on where the regulatory/legal frameworks stand in their respective jurisdictions and offer insights as to the current and upcoming regulatory developments industry need to be ready for. The specific guidelines framework evolution impacting the development and registration of future biosimilar medicines will be covered as well as information on the evolution of biosimilar policy and international regulatory convergence & cooperation initiatives.
Speaker(s)
Leah Christl, PHD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Emer Cooke, MBA, MSC
European Medicines Agency, Netherlands
Chair, ICMRA; Executive Director
Rana Malkawi
Jordan Food and Drug Administration (JFDA), Jordan
Drug Directorate Director
Michelle Werneck de Oliveira
Brazilian Health Surveillance Agency (ANVISA), Brazil
Helth Surveillance and Regulation Specialist