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Session 5: Global Regulatory Policies
Session Chair(s)
David Gaugh, RPh
Senior Vice President for Sciences and Regulatory Affairs
Generic Pharmaceutical Association (GPhA), United States
The market for biosimilars is predicted to rise rapidly as patents expire for blockbuster biologics. The approval and regulation of biosimilars are areas of notable regulatory innovation for now and for the foreseeable future. In order to have an efficient mechanism for initial approval and ongoing oversight with a country-specific focus, reaching convergence and/or harmonization among international regulatory authorities is essential. Speakers from different regions will provide updates and commentary on approvals and regulatory requirements for biosimilars.
Speaker(s)
Local Analytical and Clinical Studies for Biosimilars: Global Overview, Necessity and Consequences
Thomas Kirchlechner, PhD
Sandoz Biopharmaceuticals Development (Novartis), Austria
Head, Regulatory Emerging Markets
US FDA Engagement in the Global Development of Biosimilars
Leah Christl, PhD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Harmonization of Regulatory Expectations for Biosimilar Development, an Industry Perspective
Laura McKinley, PhD
Pfizer Inc, United States
Director, Global Regulatory Policy and Intelligence
Biosimilar Regulation in Japan – An Update
Daisaku Sato, PhD, MPharm, RPh
Ministry of Health, Labour and Welfare, Japan
Director, Compliance & Narcotics Division
Standards for Regulatory Evaluation of Biotherapeutics Including Biosimilars: WHO Approach
Ivana Knezevic
World Health Organization, Switzerland
Technical Standards and Specifications Unit (TSS)
Panel Discussion
All Session Speakers and Niklas Elkman
United States
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