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LS39: Utilization method of electronic data submitted for J-NDA filing
Session Chair(s)
Natsuko Hamada
Head of Regulatory Affairs
Swedish Orphan Biovitrum Japan, Japan
Speaker(s)
Daisuke Iwata
Pharmaceuticals and Medical Devices Agency, Japan
Office of Advanced Evaluation with Electronic Data
Masayuki Tagami
Pfizer R&D Japan G.K., Japan
Manager, Regulatory Strategy Group 2, Regulatory Affairs
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