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Session 2 :Revision of ICH Q5A and Upcoming Challenges for Virus Safety Management of Gene and Cell Therapy Products
Session Chair(s)
Yoji Sato, PhD
Head, Division of Drugs
National Institute of Health Sciences, Japan
Ryutaro Hirasawa
CMC Regulatory Affairs, Manager
Daiichi Sankyo Co., Ltd., Japan
Speaker(s)
Akira Sakurai, PhD
Akira Sakurai, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior scientist for biopharmaceutical quality
Alison Armstrong
Alison Armstrong
Merck BioReliance, United Kingdom
Global Head of Field Technology Management
Tomoko Hongo
Tomoko Hongo
Asahi Kasei Medical Co., Ltd., Japan
Lead expert