Yoji Sato

Appearances

Cell & Gene Therapy Products – Showcase both Regulatory and CMC Issues via Case Studies and Recent Challenges Toward Solving Regulatory Issues in Japan - English
Date
December 6, 2022
Recently, as the number of approved Regenerative Medical Products (RMPs) in Japan has been rising, companies are expected to face a number of challenges specific to the Cell Therapy and/or Gene Therapy Products…
Session Chair
Yoji Sato
Speakers
Gentaro Tajima
Mitsuo Kitada
Naoyuki Hanada
Seiichi Kanzaki
Atsushi Nishikawa
Yoko Momonoi
Christiane Niederlaender
Viral Safety of Biotechnology Products – Changing the Regulatory Landscape, Modalities and Analytical Technologies - English
Date
December 6, 2022
The ICH Q5A guideline considers testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal origin…
Session Chairs
Yoji Sato
Andrew Chang
Speakers
Gilles Chénard
SHOHEI KOBAYASHI
Akira Sakurai
Munehisa Masuda
Huixing Feng