ICHPharmaceutical Regulations in Japan

The 18th ICH Public Meeting

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

  Presentation materials Speakers
01_ Overview of ICH Topics Takayuki Okubo, MHLW
Topics for the Electronic Exchange of Information 02_Electronic Standards for the Transfer of Regulatory Information Yasuhiro Araki, MHLW(PMDA)
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
Efficacy Topic 04_E2F:Development Safety Update Report Noriko Akagi, JPMA
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
06_E16:Biomarkers Related to Drugs or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions Akihiro Ishiguro,
MHLW(PMDA)
Quality Topics 07_Q10:Pharmaceutical Quality System Tetsu Yamada, JPMA
08_Q11:Development and Manufacture of Drug Substances(Chemical Entities and Biotechnological/Biological Entities) Yoshihiro Matsuda, MHLW(PMDA)

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