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