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TOC Ariake Convention Hall

Nov 12, 2016 9:00 AM - Nov 12, 2016 6:00 PM

3-5-7 Ariake, , Koto-ku, Tokyo, 135-0063 Japan

ICH/DIA Joint Tokyo Workshop After ICH Japan Meeting

SESSION 1:ICH REFORM AND DIA CONTRIBUTION

Session Chair(s)

Kazumichi  Kobayashi, RPh

Kazumichi Kobayashi, RPh

Executive Deputy President (Board Member)

Otsuka Medical Devices Co., Ltd., Japan

Junko  Sato, PhD

Junko Sato, PhD

Associate Executive Director

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Speaker(s)

Lenita  Lindström, LLM

Overview of ICH Reform and Its Vision

Lenita Lindström, LLM

European Commission, Belgium

ICH Assembly Chair and Senior Expert, European Commission

Toshiyoshi  Tominaga, PhD

ICH Reform and Asian Regulatory Convergence

Toshiyoshi Tominaga, PhD

Keio University Hospital, Japan

Project Professor

Tatsuo  Kurokawa, DIAFellow, PhD

DIA’s Contribution for ICH – Role of a Platform

Tatsuo Kurokawa, DIAFellow, PhD

The Japan Biosimilar Association, Japan

Director General

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