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KFC Hall

Dec 15, 2017 9:30 AM - Dec 15, 2017 6:30 PM

1-6-1 Yokoami, Sumida-ku, Tokyo, 130-0015 Japan

2nd DIA Cell Therapy Products Symposium in Japan

Session 1 - Points to Consider from a Quality Standpoint at Drawing up Development Strategies of Cell Therapy Products

Session Chair(s)

Teruyo  Arato, PHD

Teruyo Arato, PHD

Professor, Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Japan

Hideki  Onimatsu, PHD

Hideki Onimatsu, PHD

Manager, Regulatory CMC, Regulatory Affairs Department, Takeda Pharmaceutical Company Limited, Japan

Speaker(s)

Takehiko  Kaneko, MD

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

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

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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