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[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)
Taku Watanabe
Principal IT Expert, Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
eCTD v4.0 Implementation - ICH and JP
Mark A. Gray
Senior Project Manager, DSB, CBER, FDA, United States
Preparing for eCTD v4.0 - US Implementation
Kristiina Puusaari, MBA, PMP
Digital Business Transformation Programme eSubmission Senior Coordinator, European Medicines Agency, Netherlands
Preparing for eCTD v4.0 – EU and EMA Implementation