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Session 3 - Challenges of Clinical Development for Cell Therapy Products & Patient Registry at Launch
Session Chair(s)
Keiji Miyamoto
Principal Post-Marketing Regulatory Affairs Dep.
Daiichi Sankyo Co.,Ltd., Japan
Kazuhiro Takekita
Instructor, Department of Cardiovascular Surgery, Graduate School of Medicine,
Osaka University, Japan
Speaker(s)
Operational challenges in clinical trial for regenerative product
Shiho Sugiura, MSc
Novartis Pharma K.K., Japan
Manager, Cell Gene Therapy Department
Deliver a Regenerative Medicine - From Development of a Novel Cell Delivery System to Establishment of Comprehensive Educational Program
Shoichiro Goto, PhD
Janssen Pharmaceutical K.K., Japan
Director, Frontier Development Unit
Registry Development for Regenerative Medicine
Tsutomu Makino
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office of Safety I
PMS for Regenerative Medicine at J-TEC
Masukazu Inoie
Japan Tissue Engineering Co., Ltd., Japan
PMS for HeartSheet®
Kouichi Tsuji
Terumo Corporation, Japan
General Manager, Clinical Development Department
Data Center Preparation by National Consortium, JSRM
Kiyoshi Okada, MD, PhD
Osaka University Hospital, Japan
Vice Director, Medical Ctr for Translational Research,Dept of Medical Innovation
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