ICH Project The 34th ICH Public Meeting
Zendentsu Hall, Tokyo

July 21, 2016

The 34th ICH public meeting was held in Japan which took place at the Zendentsu Hall, Chiyoda-ku in Tokyo in July 21, 2016.

This public meeting aims to provide an opportunity to update the public on the information of the progress made during the ICH meeting in Lisbon from June 11 to 16, 2016. 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 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, Osaka Pharmaceutical Manufacturers Association and Japan Pharmaceutical Association.

Working Language
Japanese
Simultaneous English-Japanese Translation
Not Available
Location Date
Zendentsu Hall,
3-6, Kanda Surugadai, Chiyoda-ku, Tokyo,
Japan
July 21, 2016 10:00 am ~4:15 pm

Program: The 34rd ICH Public Meeting (302KB)

Side-scrollable

  Presentation materials Speakers

 

Opening remarks

Hironobu Saito, JPMA

 

01_ICH Organizational Changes and Summary of ICH Meetings in Lisbon (883KB)

Fumihito Takanashi, MHLW

02_ICH activities New Topic Discussion (344KB)

Hironobu Saito, JPMA

03_ICH activities Introduction to Industry Executive Council (IEC) (423KB)

Masafumi Yokota, JPMA

Safety Topics

04_S5 (R3) EWG Revision on Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility (243 KB)

Michio Fujiwara, JPMA

05_S11 EWG Nonclinical Safety Testing in support of Development of Pediatric Medicines (417KB)

Yuji Takahashi, NIHS

Quality Topics

06_Q11 IWG Q&As on Selection and Justification of Starting Materials for the Manufacture of Drug Substances (810KB)

Kazunori Takagi, PMDA

07_Q12 EWG Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (832KB)

Masaaki Wada, JPMA

Efficacy Topics

08_E6(R2)EWG Integrated Addendum Good Clinical Practice (424KB)

Hazuki Takaura, PMDA

09_ E9 (R1) EWG Addendum to Statistical Principles for Clinical Trials (653KB)

Satoru Tsuchiya, JPMA

10_E11(R1)EWG Addendum to Clinical Investigation of Medicinal Products in the Pediatric Population (465KB)

Michiyo Sakiyama, PMDA

Topics for the Electronic Exchange of Information

11_E2B(R3)IWG Q&As on Electronic Transmission of Individual Case Safety Reports (ICSRs) (302KB)

Takashi Misu, PMDA

12_M4E(R2)EWG Enhancing the Format and Structure of Benefit-Risk Information in ICH M4E(R1) Guideline (360KB)

Katsuhiko Ichimaru, PMDA

Developed Topics

13_S9 IWG Q&As on Nonclinical Evaluation for Anticancer Pharmaceuticals (300KB)

Dai Nakae, MHLW (TUA*)

14_ E17 EWG General principle on planning/designing Multi-Regional Clinical Trials(MRCT) (916KB)

Yoshiaki Uyama, PMDA

 

Closing Remarks

Mitsuo Mihara, JPMA

  • *
    NIHS: National Institute of Health Sciences
    TUA: Tokyo University of Agriculture

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