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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)
Leah Christl, PHD
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy, Amgen, United States
FDA Update
Cathy A. Parker
Director General, Biologics & Genetic Therapies Directorate HPFB, Health Canada, Canada
Health Canada Update
Martina Weise, DrMed, MD
Head, Licensing Division 2, BfArM; German CHMP Alternate, Bfarm, Germany
CHMP Update
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