ICH Project Workshop on the ICH E2F Guideline
October 02, 2008
Workshop on the ICH E2F Guideline was held in Japan which took place at the Tower Hall Funabori, Edogawa-ku in Tokyo on October 2, 2008.
This workshop aimed to provide the explanation of DSUR mainly focused on data from interventional clinical trials (referred to in this document as " This workshop aimed to provide the explanation of DSUR mainly focused on data from interventional clinical trials (referred to in this document as "clinical trials") which reached Step 2 at ICH Portland meetings in June 2008.
Over 350 participants from pharmaceutical industries attended this workshop and had vigorous Q&A discussion. The workshop was organized by the Japan Pharmaceutical Manufacturers Association (JPMA).
- Working Language
- Japanese
- Simultaneous English-Japanese Translation
- Not Available
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- Location
- Tower Hall Funabori, 4-1-1, Funabori, Edogawa-ku, Tokyo, Japan
- Date
- October 2, 2008 1:00 p.m.-4:10 p.m.
- Presentation material
- Presentation in Japanese used at this workshop is available on the following link.
| Presentation materials | Speakers |
|---|---|
| 01_Welcoming Address | Kohei Wada, JPMA |
| 02_DSUR: Objective | Noriko Akagi, JPMA |
| 03_DSUR Step 2 Guideline | Noriko Akagi, JPMA
Yukiko Watabe, JPMA |
| 04_Q&A Discussion | Noriko Akagi, JPMA
Yukiko Watabe, JPMA Tomohiro Tsuji, JPMA Mayumi Hagiwara, JPMA |