ICH Project Workshop on the ICH M8 (eCTD v4.0)(JPMA, Nihonbashi Life Science Building, Tokyo)
August 08, 2017
The Workshop on the ICH M8 Guideline was held in Japan which took place at JPMA Building in Tokyo on August 8, 2017.
ICH M8 has continued a discussion on a new electronic specification of eCTD in order to harmonize in ICH. eCTD v4.0 specification was reached to step2 in November 2014 and step4 in December 2015. ICH eCTD v4.0 implementation Guide has been published on ESTRI page of ICH web site.
Notifications which will be implemented in Japan of eCTD v4.0 have been published in July 5th, 2017.
This workshop aimed to provide the explanation of eCTD v4.0 Implementation Guide from PMDA and JPMA in order to promote understanding a new specification for eCTD. The suggestion that what a pharmaceutical company should do before implementation of eCTD v4.0 was also provided.
The workshop was organized by the Japan Pharmaceutical Manufacturers Association (JPMA). All the information as well as the presentation used at the workshop in Japanese is available as below.
- Working Language
- Japanese
- Simultaneous English-Japanese Translation
- Not Available
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- Program Chair
- Kayoko Ichikawa, Akiyo Fujikawa, Ryoichi Hiruma, Hitoshi Matsui (JPMA)
- Location
- Nihonbashi Life Science Building (JPMA) 2-3-11, Nihonbashi Honcho, Chuo-ku, Tokyo
- Date
- August 8, 2017 1:30 pm ～4:30 pm
| Presentation Title | Speakers | |
|---|---|---|
| 13:30-13:35 | Opening remarks | Hironobu Hiyoshi, JPMA |
| 13:35-14:25 | For successfully implementation of eCTD v4.0 in Japan. (1819KB) | Taku Watanabe, PMDA |
| 14:40-15:15 | Key-points of understanding eCTD v4.0 notifications by pharmaceutical company. (1653KB) | Kayoko Ichikawa, JPMA |
| 15:15-15:35 | Adaption to eCTD v4.0 in pharmaceutical company.(475KB) | Ryoichi Hiruma, JPMA |
| 15:55-16:25 | Q&A Session (222KB) | M8 EWG/IWG Members |
| 16:25-16:30 | Closing Remarks | Masafumi Yokota, JPMA |