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SESSION 1 : ICH Q5A – Current Discussion Status and Major Issues
Session Chair(s)
Yoji Sato, PhD
Head, Division of Drugs
National Institute of Health Sciences, Japan
Kazuhisa Uchida
Kobe University, Japan
Speaker(s)
Regulations for Viral Safety of Gene Therapy Products in Japan
Akira Sakurai, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior scientist for biopharmaceutical quality
Issues in ICH Q5A (R1) on Regenerative Products from Company’s Point of View
Shunsuke Saito
Healios K.K., Japan
Manager, Development G2, Development Division
Efforts of the Advanced Virus Detection Technologies Interest Group(AVDTIG)for NGS applications in Biologics
Kazuhisa Uchida
Kobe University, Japan
ICH Q5A (R2): Summary of Key Points for the Revision
Nakamura Nao
Sumitomo Dainippon Pharma Co., Ltd., Japan
Associate Director, Process R&D Laboratories
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