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SESSION 3 : Strategy for Comparability Study on Change Management of Cell Therapy Products and Gene Therapy Products
Session Chair(s)
Takehiko Kaneko, MD
Senior Vice President, Chief Medical Officer (CMO), Head of R&D
Heartseed Inc., Japan
Kazunobu Oyama, PhD
Daiichi Sankyo Company, Limited, Japan
Speaker(s)
Change Control Strategy and Comparability Evaluation for Cell Therapy Products
Keigo Kawabe
Sumitomo Pharma Co.,Ltd., Japan
Quality Officer, Regenerative & Cellular Medicine Office
Challenge to comparability evaluation and change control of Cell Therapy Product
Kazumi Sawaguchi, PhD
Sanbio Co. Ltd., Japan
Corporate Officer, Head of Regulatory Affairs and Quality Compliance
GMP quality processing of Adeno Associated viral vectors
Mats Lundgren
Cytiva, Sweden
Customer Applications Director
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