ICH Project The 40th ICH public meeting Zendentsu Hall, Tokyo

July 17, 2019

The 40th ICH public meeting was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on July 17, 2019.

This public meeting aims to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Amsterdam from June 1 to 6, 2019. 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 370 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
July 17, 2019 10:00 am ~5:50 pm Zendentsu Hall,
3-6, Kanda Surugadai, Chiyoda-ku, Tokyo,
Japan

Side-scrollable

Presentation materials Speakers

Opening remarks

Shigeki Tsuda, PMRJ

01_ICH activities (2019/07) ICH Amsterdam Meeting Report (1369KB)

Ryo Iwase, MHLW

02_ICH activities
- Summary of the Amsterdam Meetings from JPMA’ view points - (1351KB)

Hironobu Hiyoshi, JPMA

03_Q2(R2)/Q14 EWG : Analytical Procedure Development and Revision of Q2(R1)Validation of Analytical Procedures (1339KB)

Keisuke Inoue, JPMA

04_Q3D(R2) EWG : Revision of Q3D(R1) for cutaneous and transdermal products (461KB)

Masayuki Mishima, JPMA

05_Q12 EWG : Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (605KB)

Masaaki Wada, JPMA

06_ Q13 EWG : Continuous Manugacturing of Drug Substances and Drug Products (247KB)

Atsushi Aoyama, PMDA

07_M9 EWG :
Biopharmaceutics Classification System-based Biowaivers (654KB)

Hideaki Kuribayashi, PMDA

08_E8(R1) EWG : Revision of General Considerations for Clinical Trials (1350KB)

Mutsuhiro Ikuma, PMDA

09_ E9(R1) EWG : Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials (283KB)

Yuki Ando, PMDA

10_ E11A EWG : Pediatric Extrapolation (244KB)

Shinichi Kijima, PMDA

11_E17 IWG : General principle on planning/designing Multi-Regional Clinical Trials(MRCT) training material (2305KB)

Yasuto Otsubo, PMDA

12_M11 EWG : Clinical electronic Structured Harmonized Protocol (CeSHarP) (1155KB)

Ken Sakushima, PMDA

13_S5(R3) EWG : Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals (1231KB)

Kazushige Maki, PMDA

14_S11 EWG : Nonclinical Safety Testing in support of Development of Pediatric Medicines(386KB)

Takuya Nishimura, PMDA

15_M7(R2) EWG : Addendum to Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (1565KB)

Yosuke Demizu, NIHS

16_E14/S7B IWG : Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential (371KB)

Satoshi Tsunoda, PMDA

17_E2B(R3) EWG / IWG :
Electronic Transmission of Individual Case Safety Reports (ICSRs) (368KB)

Takashi Misu, PMDA

18_M2 EWG : Electronic Standards for the Transfer of Regulatory Information (ESTRI) (629KB)

Daisuke Sato, PMDA

Closing Remarks

Masafumi Yokota, JPMA

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