ICHPharmaceutical Regulations in Japan

Workshop on the ICH M8 eCTD v4.0 Step 2 Implementation Guide (Tower Hall Funabori, Tokyo)

The workshop on the ICH M8 eCTD v4.0 Step 2 Implementation Guide was held in Japan, which took place at the Tower Hall Funabori, Edogawa-ku in Tokyo on March 9, 2015.
The workshop was the first opportunity to provide the detailed explanation of ICH M8 eCTD v4.0 Step 2 Implementation Guide to the public. The M8 EWG plays a key role to assume responsibility for the continued development of the next major version of the eCTD (eCTD v4.0).
The workshop was open to the public, and over 150 participants including personnel concerned from pharmaceutical industries attended this workshop and had vigorous Q&A discussion.
This M8 implementation guide was jointly organized by the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ, non-profit organization), and supported by the Federation of Pharmaceutical Manufacturers’ Associations of Japan, the Pharmaceutical Manufacturers’ Association of Tokyo, Osaka Pharmaceutical Manufacturers Association and Japan Pharmaceutical Association.
All the presentations used at the workshop are available in Japanese as below.
Working Language: Japanese
The following documents are also attached in order to facilitate further understanding of the M8 eCTD v4.0 Step 2 Implementation Guide:

None of this publication may be reproduced by any means without the prior permission of the copyright owner.

 

Location: Tower Hall Funabori, 4-1-1, Funabori, Edogawa-ku, Tokyo, Japan
Date: March 9, 2015   10:00 am ~ 5:00 pm

Chaired by: Akiyo Fujikawa (JPMA M8 EWG Topic Leader )
  Presentation materials Speakers
10:00-10:05 Opening remarks Hironobu Saito,
JPMA
10:05-10:25 Overview of electronic submission in Japan:
General update (PDF 2189KB)
Naruhiko Hiramoto,
PMDA
10:25-10:55 Review by using eCTD  (PDF 1366KB) Masahiro Uchino,
PMDA
10:55-12:00 ICH M8 (eCTD v4.0) Step2 Implementation Guide:
Overview (PDF 797KB)
Taku Watanabe,
PMDA
13:00-15:00 ICH M8 (eCTD v4.0) Step2 Implementation Guide:
Technical details (PDF 1200KB)
Taku Watanabe,
PMDA
15:00-15:10 ICH M8 (eCTD v4.0) Step2 Implementation Guide:
Q&A
Taku Watanabe,
PMDA
15:30-16:50 Introduction for the test tools (PDF 1532KB) Taku Watanabe,
PMDA
Instruction manual for the test tools  (PDF 697KB) Kayoko Ichikawa
JPMA M8 EWG Expert
16:50-17:00 Closing remarks Kurajiro Kishi, JPMA

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