ICH Project The 48th ICH Public meeting Webinar

December 26, 2023

The 48th ICH public meeting was held in Japan on December 20, 2023.

This Webinar aims to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Prague on October 28 to November 1, 2023. 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 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
Presentation Material
Only available in Japanese

Date and Format

Date Format
December 20, 2023 10:00 am ~3:50 pm Online - Zoom

Program: The 48th ICH Public MeetingPDF

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Presentation materials Speakers

Opening remarks

Kazuhiko MORI,
JPMA

01_ICH activities
- Prague Meeting Report
PDF
 -

Mao MATSUMOTO,
MHLW

02_ICH activities
- Summary of the ICH Purague Meetings from JPMA’ viewpoints -
PDF

Masafumi YOKOTA,
JPMA

03 M11 EWG: Clinical electronic Structured Harmonised ProtocolPDF

Hiroshi SAKAGUCHI,
PMDA

04 M12 EWG: Drug Interaction StudiesPDF

Akihiro ISHIGURO,
PMDA

05_M13 EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms PDF Toru YAMAGUCHI,
PMDA
06 M15 EWG: General Principles for Model-Informed Drug DevelopmentPDF Daisuke IWATA,
PMDA
07 M4Q(R2)EWG: Reision of M4Q(R1) CTD on Quality guidancePDF

Issei TAKAYAMA,
PMDA

08 Q1/Q5C EWG: Targeted Revisions of the ICH Stability Guideline SeriesPDF

Tatsuo KOIDE,
NIHS

09 Q2(R2)/Q14 EWG: Analytical Procedure Development and Revision of Q2(R1) Analytical ValidationPDF

Hiroko SHIBATA,
NIHS

10 Q3E EWG: Impurity: Assessment and Control of Extractables and Leachables for Pharmaceuticals and BiologicsPDF

Kazusei KOMATSU,
JPMA

11 Q5A(R2) EWG: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal OriginPDF Akira SAKURAI,
PMDA
12 Q9(R1) IWG: Quality Risk ManagementPDF Tomoaki SAKAMOTO,
NIHS
13 E2B(R3) EWG/IWG: Electronic Transmission of Individual Case Safety Reports (ICSRs) PDF Yukie YAMAGUCHI,
PMDA
14 E6(R3) EWG: Good Clinical PracticePDF Izumi OBA,
PMDA
15 E11A EWG: Pediatric ExtrapolationPDF Shinichi KIJIMA,
PMDA
16 E20 EWG: Adaptive Clinical TrialsPDF Yuki ANDO,
PMDA
17 E21 EWG: Inclusion of Pregnant and Breast-feeding Individuals in Clinical TrialsPDF Yoko MOTOKI,
PMDA
 Closing Remarks  Haruhiko Okuda,
PMRJ

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