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[V1-S1] Vision for the Future: Global Simultaneous Filing to the World First Approval - Strategies for Early NDA Approval
Session Chair(s)
Satomi Ando, MSC
Manager, Clinical Research & Medical Development Center
Japanese Foundation For Cancer Research, Cancer Institute Hospital , Japan
Speaker(s)
An Experience of the First Submission in JapanAhead of Other Regions: A Case of Global NDA Filing for 2 Indications in 1 Submission
Tomohiko Kumakura, MSC
Daiichi Sankyo Co., Ltd., Japan
Senior Director
Opportunities and Challenges in the Preparation of a World-First Japan Filing in a Global Development Project
Yuka Wakimura, PHD
Janssen Pharmaceutical K.K., Japan
Director, Regulatory Development Dept.