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Session 2 - Points to Consider from Comparability of Cell Therapy
Session Chair(s)
Kazuhiro Takekita
Instructor, Department of Cardiovascular Surgery, Graduate School of Medicine,
Osaka University, Japan
Speaker(s)
Quality Aspects of Regenerative Medical Products
Kanako Watanabe, PhD
Pharmaceuticals and Medical Device Agency, Japan
Reviewer, Office of Cellular and Tissue-basaed Products
Points to Consider on ATMPs’ Comparability Assessment on Manufacturing Change in Europe (Tentative)
Margarida Menezes-Ferreira, PhD
National Authority of Medicines and Health Products (INFARMED), Portugal
Scientific and Regulatory Advice Coordinator
Manufacturing Change Approach on Allogeneic Cell Therapy Products
Kiwamu Imagawa, PhD
JCR Pharmaceuticals Co., Ltd., Japan
Director, Regenerative Medicine, Research Division
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