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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

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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

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

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

Ryoko Naruse, PhD

GCTP Manufacturing / Quality Control of Regenerative Medicine in JAPAN

Ryoko Naruse, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Division Director, Office of Manufacturing

Margarida Menezes-Ferreira, PhD

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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