ICHPharmaceutical Regulations in Japan

Workshop on the ICH E2F Guideline

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. http://www.jpma.or.jp/information/ich/pdf/ich_topicE2F_step2.pdf

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

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