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S12 : Evidence Requirements for Conditional and Time-Limited Approval: Statistical Evaluation of Small-Sample Regenerative Products
Session Chair(s)
Junichi Asano, PhD
Associate Senior Biostatistician, Office of New Drug IV, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker(s)
Satoshi Teramukai, PhD
Professor, Department of Biostatistics, Kyoto Prefectural University of Medicine, Japan
Yoshiaki Maruyama, PhD
Review Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Akihiro Hirakawa, PhD
Professor, Department of Clinical Biostatistics, Institute of Science Tokyo, Japan
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