ICH Project The 41st ICH public meeting Zendentsu Hall, Tokyo

December 18, 2019

The 41st ICH public meeting was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo on December 18, 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 Singapore from November 16 to 20, 2019. At the beginning, we had presentations about the current 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 and Place

Date Place
December 18, 2019 10:00 am ~5:10 pm Zendentsu Hall,
3-6, Kanda Surugadai, Chiyoda-ku, Tokyo,
Japan

Program: The 41st ICH Public Meeting (278KB)

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Presentation materials Speakers

Opening remarks

Akira Kawahara, JPMA

01_ICH activities ICH Singapore Meeting Report (1630KB)

Ryo Iwase, MHLW

02_ICH activities
- Summary of the Singapore Meetings from JPMA’s viewpoints - (1751KB)

Hironobu Hiyoshi, JPMA

03_Q12 EWG: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (871KB)

Satomi Yagi, PMDA

04_Q2(R2)/Q14 EWG: Analytical Procedure Development and Revision of Q2(R1) Validation of Analytical Procedures (869KB)

Hiroko Shibata, NIHS

05_Q13 EWG: Continuous Manufacturing of Drug Substances and Drug Products (234KB)

Atsushi Aoyama, PMDA

06_Q5A(R2) EWG: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (242KB) Annex (405KB)

Yoji Sato, NIHS

07_E14/S7B IWG: Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential (256KB)

Satoshi Tsunoda, PMDA

08_M10 EWG: Bioanalytical Method Validation (824KB)

Daisuke Iwata, PMDA

09_ S12 EWG: Nonclinical Biodistribution Studies for Gene Therapy Products
(299KB)

Mizuho Nonaka, PMDA

10_ E19 EWG: Optimisation of Safety Data Collection (316KB)

Kinue Nishioka, PMDA

11_ E11A EWG: Pediatric Extrapolation (239KB)

Shinichi Kijima, PMDA

12_M11 EWG: Clinical electronic Structured Harmonized Protocol (CeSHarP) (1157KB)

Ken Sakushima, PMDA

13_E2D(R1) EWG: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting (347KB)

Sho Suzuki, PMDA

14_E6(R3) EWG: Good Clinical Practice (220KB)

Aki Kitabayashi, PMDA

15_E20 EWG: Adaptive Clinical Trials (150KB)

Yuki Ando, PMDA

16_M12 EWG: Drug Interaction Studies (757KB)

Akihiro Ishiguro, PMDA

Closing Remarks

Shigeki Tsuda, PMRJ

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