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戻る Agenda
Session 1 : Ethical Perspectives and Ind-Aca-Gov Initiatives on Providing Out-of-Specification Autologous Cell Products
Session Chair(s)
Masafumi Onodera, MD, PhD
Director, Center of Gene Cell Therapy Promotion,
National Center for Child Health and Development, Japan
Yoshie Tsurumaki
Group Manager, Cell & Gene Franchise
Novartis Pharma K.K., Japan
Speaker(s)
Initiatives to Address Patient Access to Out-of-Specification Products
Yayoi Kitawaki, MS
Novartis Pharma K.K., Japan
Department Head, Neuroscience, GTx Development Unit
About Theme (1) (Safety which Corresponds to a Problem of Access and Establishment of a Quick Approval System to Drug Losses and Medical Products of a Short Supply, etc.).
Akira Iino
Ministry of Health, Labour and Welfare, Japan (MHLW), Japan
Medical Device Evaluation Division
First Results of Out-of-Specification Tisagenlecleucel in Japanese Patients With R/R B-ALL and R/R DLBCL
Koji Kato
Kyushu University, Japan
Faculty of Medical Sciences Department of Clinical Medicine Associate Professor
Kiyoshi Okada, MD, PhD
Osaka University Hospital, Japan
Vice Director, Medical Ctr for Translational Research,Dept of Medical Innovation