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Tokyo Big Sight

Nov 13, 2016 9:30 AM - Nov 15, 2016 5:30 PM

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

13th DIA Japan Annual Meeting 2016

[V3-S3] Towards the Implementation of M8 Guideline "eCTD Ver.4"

Session Chair(s)

Akiyo  Fujikawa

Akiyo Fujikawa

Daiichi Sankyo Company, Limited, Japan

Masahiro  Uchino, PhD

Masahiro Uchino, PhD

Office of New Drug II

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

The ICH-M8 guideline “eCTD (electronic common technical document) Ver.4” was adopted in December 2015. Presenters will explain the roadmap for implementation in each region and characteristics of issues arising from the impact of implementing the harmonized eCTD Ver.4.

Speaker(s)

Taku  Watanabe

eCTD v4.0 Implementation - ICH and JP

Taku Watanabe

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Principal IT Expert, Office of Review Management

Mark A. Gray

Preparing for eCTD v4.0 - US Implementation

Mark A. Gray

FDA, United States

Senior Project Manager, DSB, CBER

Kristiina  Puusaari, MBA, PMP

Preparing for eCTD v4.0 – EU and EMA Implementation

Kristiina Puusaari, MBA, PMP

European Medicines Agency, Netherlands

eSubmission Programme Management, Human Medicines Evaluation

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