ICH Project The 18th ICH Public Meeting
August 05, 2008
The 18th ICH Public Meeting was held in Japan which took place at the Kudan Hall, Meguro-ku in Tokyo on August 5, 2008.This Public Meeting aimed to provide an opportunity to give the public updated information on the progress made during the ICH Meeting in Portland in June 2008, and on the status of the various ICH Guidelines under development with a follow-up Q & A session.
- Working Language
- Japanese
- Simultaneous English-Japanese Translation
- Not Available
- Location
- Kudan Hall, 1-1, Surugadai, Kanda, Chiyoda-ku, Tokyo, Japan
- Date
- August 5, 2008
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Presentation materials | Speakers |
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01_ Overview of ICH Topics |
Takayuki Okubo, MHLW |
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Topics for the Electronic Exchange of Information |
02_Electronic Standards for the Transfer of Regulatory Information |
Yasuhiro Araki, MHLW(PMDA) |
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Safety Topic |
03_M3(R2):Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals |
Fumio Sagami, JPMA |
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Efficacy Topic |
04_E2F:Development Safety Update Report |
Noriko Akagi, JPMA |
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05_E14 IWG Q&A: Questions & Answers: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs |
Maki Ito, JPMA |
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06_E16:Biomarkers Related to Drugs or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions |
Akihiro Ishiguro, |
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Quality Topics |
07_Q10:Pharmaceutical Quality System |
Tetsu Yamada, JPMA |
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08_Q11:Development and Manufacture of Drug Substances(Chemical Entities and Biotechnological/Biological Entities) |
Yoshihiro Matsuda, MHLW(PMDA) |