Workshop on the ICH M8 eCTD v4.0 Step 2 Implementation Guide, 9 March 2015, Tokyo, Japan

The workshop on the ICH M8 eCTD v4.0 Step 2 Implementation Guide (IG) was held on 9 March 2015 at the Tower Hall Funabori, Edogawa-ku in Tokyo, Japan.

The workshop was the first opportunity to provide detailed explanation on ICH M8 eCTD v4.0 Step 2 (IG) 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 welcomed over 150 participants which contributed to an animated Q&A discussion.

This workshop was jointly organised 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 on the JPMA website.

At a Glance...

9 March 2015 Tower Hall Funabori, Tokyo