戻る Agenda
[V3-S3] Towards the Implementation of M8 Guideline "eCTD Ver.4"
Session Chair(s)
Akiyo Fujikawa
Senior Director of Regulatory Affairs
Aurion Biotech Japan, LLC, Japan
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)
eCTD v4.0 Implementation - ICH and JP
Taku Watanabe
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal IT Expert, Office of Review Management
Preparing for eCTD v4.0 - US Implementation
Mark A. Gray
FDA, United States
Senior Project Manager, DSB, CBER
Preparing for eCTD v4.0 – EU and EMA Implementation
Kristiina Puusaari, MBA, PMP
European Medicines Agency, Netherlands
Digital Business Transformation Programme eSubmission Senior Coordinator