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Session 1 - Points to Consider from a Quality Standpoint at Drawing up Development Strategies of Cell Therapy Products
Session Chair(s)
Teruyo Arato, PHD
Professor, Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Japan
Hideki Onimatsu, PHD
Manager, Regulatory CMC, Regulatory Affairs Department, Takeda Pharmaceutical Company Limited, Japan
Speaker(s)
Takehiko Kaneko, MD
Senior Vice President, Chief Medical Officer (CMO), Head of R&D, Heartseed Inc., Japan
Quality of Regenerative Medical Product –Challenge for Industrialization–
Ryoko Naruse, PHD
Division Director, Office of Manufacturing, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
GCTP Manufacturing / Quality Control of Regenerative Medicine in JAPAN
Margarida Menezes-Ferreira, PHD
Scientific and Regulatory Advice Coordinator, National Authority of Medicines and Health Products (INFARMED), Portugal
Good Manufacturing Practices forAdvanced Therapy Medicinal Products in Europe
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