ICH Project The 39th ICH Public Meeting Zendentsu Hall, Tokyo

December 14, 2018

The 39th ICH public meeting was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on December 14, 2018.

This public meeting aims to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Charlotte from November 10 to 15, 2018. At the beginning, we had presentations about the present situation of ICH then move to the topic on the status of various ICH Guidelines. Approximately over 220 participants from not only pharmaceutical industries but also relevant industries attended this meeting and had vigorous Q&A discussion.

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, Kansai Pharmaceutical Industries Association and Japan Pharmaceutical Association.

Working Language
Japanese
Simultaneous English-Japanese Translation
Not Available
Date Place
December 14, 2018 10:00 am ~4:50 pm Zendentsu Hall,
3-6, Kanda Surugadai, Chiyoda-ku, Tokyo,
Japan

Program: The 39th ICH Public Meeting (490KB)

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Presentation materials Speakers

Opening remarks

Akira Kawahara, JPMA

01_ICH activities – after 7th ICH meeting at Charlotte- (935KB)

Fumihito Takanashi, MHLW

02_ICH activities – Summary of the Charlotte Meetings from JPMA’ view points -(1116KB)

Hironobu Hiyoshi, JPMA

03_Q2(R2)/Q14 EWG : Analytical Procedure Development and Revision of Q2(R1) Validation of Analytical Procedures (623KB)

Yukio Hiyama, NIHS

04_Q13 EWG : Continuous Manugacturing of Drug Substances and Drug Products(454KB)

Atsushi Aoyama, PMDA

05_E14/S7B IWG : Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential (422KB)

Kaori Shinagawa, PMDA

06_E8(R1) EWG : Revision of General Considerations for Clinical Trials (802KB)

Mutsuhiro Ikuma, PMDA

07_ E9(R1) EWG : Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials(342KB)

Yuki Ando, PMDA

08_ E11A EWG : Pediatric Extrapolation (288KB)

Shinichi Kijima, PMDA

09_E17 IWG : General principle on planning/designing Multi-Regional Clinical Trials(MRCT) training material (1576KB)

Yasuto Otsubo, PMDA

10_ E19 EWG : Optimisation of Safety Data Collection (390KB)

Kinue Nishioka, PMDA

11_M11 EWG : Clinical electronic Structured Harmonized Protocol (CeSHarP)(1269KB)

Motoki Mikami, PMDA

12_S1(R1) EWG : Revision of the Rodent Carcinogenicity Studies for Human Pharmaceuticals Guideline (500KB)

Kumiko Ogawa, NIHS

13_S5(R3) EWG : Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals (1200KB)

Kazushige Maki, PMDA

14_M7(R2) EWG : Addendum to Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk(1406KB)

Masamitsu Honma, NIHS

15_M10 EWG : Bioanalytical Method Validation (832KB)

Daisuke Iwata, PMDA

Closing Remarks

Shigeki Tsuda, PMRJ

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