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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)
Quality of Regenerative Medical Product –Challenge for Industrialization–
Takehiko Kaneko, MD
Heartseed Inc., Japan
Senior Vice President, Chief Medical Officer (CMO), Head of R&D
GCTP Manufacturing / Quality Control of Regenerative Medicine in JAPAN
Ryoko Naruse, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Division Director, Office of Manufacturing
Good Manufacturing Practices forAdvanced Therapy Medicinal Products in Europe
Margarida Menezes-Ferreira, PhD
National Authority of Medicines and Health Products (INFARMED), Portugal
Scientific and Regulatory Advice Coordinator
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