ICH Project ICH Japan Symposium 2012 (The 26th ICH Public Meeting)

July 25, 2012

The meeting entitled "ICH Japan Symposium 2012", the fourth ICH-branded regional meeting held in Japan which took place at the Tsuda Hall, Shibuya-ku in Tokyo on July 25, 2012.

The Symposium aimed to provide an opportunity to update the public on the progress made during the ICH meeting in Fukuoka in June 2-7, 2012 and on the status of the various ICH Guidelines under development. It was also an opportunity for participants and the ICH experts/rapporteurs to have a face to face Q&As session on all topics discussed at the Fukuoka Meetings. Approximately 300 participants from pharmaceutical industries attended the Symposium and had vigorous Q&A discussion especially in the safety and efficacy session.

The Symposium was jointly organised by the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ, non-profit organisation), and supported by the Ministry of Health, Labour and Welfare (MHLW), the Federation of Pharmaceutical Manufacturers' Associations of Japan, the Pharmaceutical Manufacturers' Association of Tokyo, the Osaka Pharmaceutical Manufacturers Association and the Japan Pharmaceutical Association. All the presentation used at the symposium is available in Japanese as below.

Working Language
Japanese
Simultaneous English-Japanese Translation
Not Available

None of this publication may be reproduced by any means without the prior permission of the copyright owner.

Location
Tsuda Hall, 1-18-24, Sendagaya Shibuya-ku, Tokyo, Japan
Date
July 25, 2012 10:00 a.m. -4:40 p.m.

Program:ICH Japan Symposium 2012(67KB)

Side-scrollable

  Presentation materials Speakers

 

00_Welcoming Address(74KB)

Kohei Wada, JPMA

01_Recent Developments of ICH(316KB)

Naoyuki Yasuda, MHLW

02_Overviews of ICH Topics(303KB)

Kurajiro Kishi, JPMA

Topics for the Electronic Exchange of Information

03_M2: Electronic Standards for the Transfer of Regulatory Information(1,667KB)

Koji Shomoto, JPMA

04_E2B (R3): Revision of the Electronic Submission in Individual Case Safety Reports(389 KB)

Ayumi Endo, MHLW(PMDA)

05_M5: Data Elements and Standards for Drug Dictionaries(968KB)

Maiko Suzuki,MHLW(PMDA)

06_M8: Electronic Common Technical Document(539KB)

Akiyo Fujikawa, JPMA

Efficacy Topics

07_E2C (R2): Clinical Safety Data Management; Periodic Benefit Risk Evaluation Report (PBRER)(646KB)

Hazuki Takaura, MHLW(PMDA)

08_E3 IWG: Structure and Content of Clinical Study Report: Q&A(579KB)

Kayo Shinohara, MHLW(PMDA)

09_ E14 IWG: Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs: Q&A(180KB)

Maki Ito, JPMA

Safety Topics

10_ S1: Rodent Carcinogenicity Studies for Human Pharmaceuticals(197KB)

Shigeru Hisada, JPMA

11_S10: Photosafety Evaluation(273KB)

Dai Nakae, MHLW(TMIPH)

12_ M3 (R2) IWG: Revision of Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals: Q&A(1,130KB)

Fumio Sagami, JPMA

13_ M7: Genotoxic Impurities(562KB)

Shigeki Sawada, JPMA

Quality Topics

14_Q3D: Guideline for Metal Impurity(238KB)

Masayuki Mishima, JPMA

15_Q11: Development and Manufacture of Drug Substances(1,145KB)

Kazunori Takagi, MHLW(PMDA)

16_Q.B.S:Quality Brainstorming(153KB)

Yoshihiro Matsuda, MHLW(PMDA)

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