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Global Considerations
Session Chair(s)
Mary Ellen Cosenza, PhD, MS, RAC
President
MEC Regulatory & Toxicology Consulting, LLC, United States
Jian Wang, MD, PhD
Division Manager, Clinical Review Division – Heamatology/Oncology
Health Canada, Canada
This session will provide high-level reviews on the regulatory framework developed for biosimilars in Canada and in key Latin America and Asia Pacific markets, identifying similarities and differences in the regulatory requirements in these markets.
Speaker(s)
Canadian Perspective
Anthony Ridgway, PhD
Health Canada, Canada
Acting Director, Biologics and Genetic Therapies Directorate
Mexican Perspective
Christian Alejandro Lopez-Silva
Baker & McKenzie S.C., Mexico
Partner
Asian Perspective
Hee Kyung Kim, MBA, RPh
Samsung Bioepis, Korea, Republic of
Sr. Vice President
Panel Discussion
All Session Speakers, United States
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