ICH Project The 33rd ICH Public Meeting Zendentsu Hall, Tokyo

January 15, 2016

The 33rd ICH public meeting was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on January 15, 2016.

This public meeting aims to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Jacksonville from December 5 to 10, 2015. At the beginning, we had presentations about the establishment of the ICH Association then move to the topic on the status of various ICH Guidelines, under development with Q & A session.

The public meeting was jointly organized by the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ, non-profit organization), and supported by the Federation of Pharmaceutical Manufacturers' Associations of Japan, the Pharmaceutical Manufacturers' Association of Tokyo, Osaka Pharmaceutical Manufacturers Association and Japan Pharmaceutical Association.

Working Language
Japanese
Simultaneous English-Japanese Translation
Not Available
Location Date
Zendentsu Hall,
3-6, Kanda Surugadai, Chiyoda-ku, Tokyo,
Japan
January 15, 2016 10:00 am ~4:25 pm

Program: The 33rd ICH Public Meeting (English) (28KB)

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  Presentation materials Speakers

 

Opening remarks

Akira Kawahara, JPMA

 

01_Overview of ICH and its reform (693KB)

Fumihito Takanashi, MHLW

02_ICH Update (1013KB)

Hironobu Saito, JPMA

Topics for the Electronic Exchange of Information

03_ M2 EWG: Electronic Standards for the Transfer of Regulatory Information (548 KB)

Katsuhiro Hashimoto, JPMA

04_M8 IWG/EWG:The Electronic Common Technical Document: eCTD (266 KB)

Taku Watanabe, PMDA

Quality Topics

05_Q11 IWG: Q&As on API Starting Materials (641KB)

Kenji Ozaki, JPMA

06_Q12 EWG: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (653KB)

Yasuhiro Kishioka, PMDA

Efficacy Topics

07_ E9 (R1) EWG: Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses (579KB)

Satoru Tsuchiya, JPMA

08_ E14 IWG: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (421KB)

Kaori Shinagawa, PMDA

09_ E17 EWG: Multi-Regional Clinical Trials (MRCT) (265KB)

Shuji Kamada, PMDA

10_ E18 EWG: Genomic Sampling and Management of Genomic Data (345KB)

Akihiro Ishiguro, PMDA

Safety Topics

11_ S1 EWG: Rodent Carcinogenicity Studies for Human Pharmaceuticals (396KB)

Akiyoshi Nishikawa MHLW(NIHS*)

12_S5 (R3) EWG: Revision on Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility (229KB)

Michio Fujiwara, JPMA

13_S9 IWG: Q&As on Nonclinical Evaluation for Anticancer Pharmaceuticals (296KB)

Dai Nakae, MHLW (TUA*)

14_S11 EWG: Nonclinical Safety Testing in support of Development of Paediatric Medicines (253KB)

Kiyoshi Matsumoto, JPMA

 

Closing Remarks

Mitsuo Mihara, JPMA

  • *
    NIHS: National Institute of Health Sciences
    TUA: Tokyo University of Agriculture

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