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Session 6: Global Harmonization and Regulator Update
Session Chair(s)
Jian Wang, MD, PhD
Division Manager, Clinical Review Division – Heamatology/Oncology
Health Canada, Canada
Biosimilars developed for launch in multiple regions require a planned and focused strategy, involving the selection of the suitable reference product(s), defining the extent of comparative process and product characterization, and design of nonclinical and clinical studies to meet regulatory requirements. A clear and concise understanding of the regulatory framework of major regions and regulatory convergence activity among regions would be desirable for a good business strategy. This session will bring together regulatory authorities to discuss current regulatory evolution and convergence for biosimilars in the various global locations.
Speaker(s)
FDA Update
Leah Christl, PhD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Health Canada Update
Cathy A. Parker
Health Canada, Canada
Director General, Biologics & Genetic Therapies Directorate HPFB
CHMP Update
Martina Weise, DrMed, MD
Bfarm, Germany
Head, Licensing Division 2, BfArM; German CHMP Alternate