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5th DIA Cell and Gene Therapy Products Symposium in Japan

This event is now offered in a new entirely virtual format.

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SESSION 1 : ICH Q5A – Current Discussion Status and Major Issues

Session Chair(s)

Yoji  Sato, PhD

Yoji Sato, PhD

  • Head, Division of Cell-Based Therapeutic Products
  • National Institute of Health Sciences, Japan
Kazuhisa  Uchida

Kazuhisa Uchida

  • Kobe University, Japan

Speaker(s)

Akira  Sakurai, PhD

Regulations for Viral Safety of Gene Therapy Products in Japan

Akira Sakurai, PhD

  • Office of Vaccines and Blood Products
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Shunsuke  Saito

Issues in ICH Q5A (R1) on Regenerative Products from Company’s Point of View

Shunsuke Saito

  • Manager, Development G2, Development Division
  • Healios K.K., Japan
Kazuhisa  Uchida

Efforts of the Advanced Virus Detection Technologies Interest Group(AVDTIG)for NGS applications in Biologics

Kazuhisa Uchida

  • Kobe University, Japan
Nakamura  Nao

ICH Q5A (R2): Summary of Key Points for the Revision

Nakamura Nao

  • Associate Director, Process R&D Laboratories
  • Sumitomo Dainippon Pharma Co., Ltd., Japan

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