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Tokyo Big Sight

2018 年 11 月 11 日 9:30 上午 - 2018 年 11 月 13 日 5:40 下午

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

15th DIA Japan Annual Meeting 2018

Innovative technologies such as AI, big data/genomics, and cell/gene therapies are poised to transform healthcare product development across the globe – join us to discuss these topics.

[V8-S1] Target Product Profile - Better Way to Build Up R&D Management Plan [Call for Abstract Session]

Session Chair(s)

Yoshio  Marumoto, MD, PHD

Yoshio Marumoto, MD, PHD

Associate Professor, Yamaguchi University Hospital, Japan

In this session, general TPP configuration items will be outlined with reference to FDA guidance. Furthermore, from the viewpoint of program management and scope management in the R & D process, we examine how effective TPP should be.

Speaker(s)

Michiko  Ishida, DRSC

Michiko Ishida, DRSC

Director, Department of Innovative Drug Discovery and Development, Japan Agency for Medical Research and Development (AMED), Japan

Project Management Checklist in AMED

Shinobu  Shimizu, PHD

Shinobu Shimizu, PHD

Associate Professor, Department of Advanced Medicine, Nagoya Univeresity Hospital, Japan

Use of the TPP as a Tool in Academia

Atsushi  Tsukamoto, PHD, MSC

Atsushi Tsukamoto, PHD, MSC

Head is Therapeutic Area Strategies , Daiichi Sankyo, United States

General Concept for TPP Utilization in Pharmaceutical Company

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