ICH Project The 49th ICH Public meeting Webinar

July 26, 2024

The 49th ICH public meeting was held in Japan on July 26, 2024.

This Webinar aims to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Fukuoka on June 1-5, 2024. At the beginning, we had presentations about the present situation of ICH then move to the topic on the status of various ICH Guidelines.

The Webinar is jointly organized by the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical and Medical Device Regulatory The Webinar is 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 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
Presentation Material
Only available in Japanese

Date and Format

Date Format
July 26, 2024 12:30 pm - 4:50 pm Online - Zoom

Program: The 49th ICH Public Meeting

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Presentation materials Speakers

Opening remarks

Kazuhiko MORI,
JPMA

01_ICH activities
- Fukuoka Meeting Report
-Nao NAKAMURA,

Mao MATSUMOTO,
MHLW

02_ICH activities
- Summary of the ICH Fukuoka Meetings from JPMA's viewpoints - Nao NAKAMURA,

Masafumi YOKOTA,
JPMA

03_ICH activities Q1/Q5C EWG: Targeted Revisions of the ICH Stability Guideline Series

Takashi KAMEDA,
PMDA

04_Q2(R2)/Q14 IWG: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation

Takafumi SAMUKAWA,
JPMA

05_Q3E EWG: Impurity: Assessment and Control of Extractables and Leachables for Pharmaceuticals and Biologics Hiroshi TAKEDA,
PMDA
06_Q5A (R2) IWG: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Nao NAKAMURA,
JPMA
07_Q6 (R1) informal WG: Maintenance of the ICH Q6A and Q6B Guidelines

Atsuko OIMURA,
PMDA

08_Q9(R1) IWG: Quality Risk Management

Aki AOYAMA,
PMDA

09_M4Q(R2)EWG: Revision of M4Q(R1) CTD on Quality guidance

Issei TAKAYAMA,
PMDA

10_M11 EWG: Clinical electronic Structured Harmonised Protocol

Hiroshi SAKAGUCHI,
PMDA

11_M13 EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms Toru YAMAGUCHI,
PMDA
12_M15 EWG: General Principles for Model-Informed Drug Development Daisuke IWATA,
PMDA
13_E6(R3) EWG: Good Clinical Practice Hiromi TAKIZAWA,
PMDA
14_E20 EWG: Adaptive Clinical Trials Yuki ANDO,
PMDA
15_E21 EWG: Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials Yoko MOTOKI,
PMDA
Closing Remarks Haruhiro Okuda,
PMRJ