ICH Project The 42nd ICH Public meetings Webinar

December 16, 2020

The 42nd ICH public meeting Webinar was held in Japan on December 16, 2020.

This Webinar aimed to provide an opportunity to update the public on the information of the progress made during the ICH activity in this year. 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 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 Format

Date Format
December 16, 2020 13:00 am ~16:40 pm Online - WebEx

Side-scrollable

Presentation materials Speakers

Opening remarks

Kazuhiko Mori, JPMA

01_ICH activities the Virtual Athens Meeting Report (1,430KB)

Hirooki Tanabe, MHLW

02_ICH activities
- Summary of the ICH Virtual Athens Meetings from JPMA’ view points - (2230KB)

Masafumi Yokota, JPMA

03_ S1(R1 : Rodent Carcinogenicity Studies for Human Pharmaceuticals (634KB)

Kumiko Ogawa, NIHS

04_ S12 EWG : Biodistribution Studies for Gene Therapy Products (296KB)

Yuto Takishima, PMDA

05_ Q3C(R8) : Residual Solvent
Q3D(R2) : Guideline for Elemental Impurities (472KB)

Akihiko Hirose, NIHS

06_Q9(R1) : Quality Risk Management (166KB)

Tomoaki Sakamoto, NIHS

07_ Q3E : Guideline for Extractables and Leachables (E&L) (373KB)

Hiroshi Takeda, PMDA

08_ Q5A(R2) EWG: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (575KB)

Youji Sato, NIHS

09_ Q2(R2)/Q14 :Analytical Procedure Development and Revision of Q2(R1)
Validation of Analytical Procedures (406KB)

Akiko Mase, NIHS

10_ Q13 EWG: Continuous Manufacturing of Drug Substances and Drug Products (316KB)

Yasuhiro Matsui, JPMA

11_ M13 : Bioequivalence for Immediate-Release Solid Oral Dosage Forms (209KB)

Ryosuke Kuribayashi, PMDA

12_ E8(R1) : Revision of General Considerations for Clinical Trials (1,013KB)

Hiroshi Sakaguchi, PMDA

13_ E11A : Pediatric Extrapolation (249KB)

Shinichi Kijima, PMDA

14_ E20 : Adaptive Clinical Trials (157KB)

Yuki Ando, PMDA

15_ M11 : CeSHarP (1,153KB)

Ken Sakushima, PMDA

16_M12 EWG: Drug Interaction Studies (964KB)

Motohiro Hoshino, PMDA

Closing Remarks

Haruhiro Okuda, PMRJ

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