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Tokyo Big Sight

Nov 16, 2014 9:00 AM - Nov 18, 2014 6:30 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

11th Annual Meeting DIA Japan 2014

[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

Satomi Ando, MSc

Manager, Clinical Research & Medical Development Center

Japanese Foundation For Cancer Research, Cancer Institute Hospital , Japan

Speaker(s)

Tomohiko  Kumakura, MSc

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

Yuka  Wakimura, PhD

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.

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