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 "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 |