ICH Project ICH Japan Symposium 2010 (The 23rd ICH Public Meeting)

December 02, 2010

ICH Japan Symposium 2010, the third ICH-branded regional meeting was held in Japan which took place at the Tsuda Hall, Shibuya-ku in Tokyo, on December 2, 2010.This Public Meeting aimed to provide an opportunity to give the public updated information on the progress made during the ICH Meeting in Fukuoka from June 6-11, 2010, and on the status of the various ICH Guidelines under development with a special session regarding pharmacovigilance. In this session, we had a comprehensive discussion about the gap among E2 guidelines (E2A, E2B, E2D, E2E, E2F) including E2C, depending on the regions.

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 Ministry of Health, Labour and Welfare (MHLW), Federation of Pharmaceutical Manufacturers' Associations of Japan, the Pharmaceutical Manufacturers' Association of Tokyo, Osaka Pharmaceutical Manufacturers Association and Japan Pharmaceutical Association. All the presentation used in the meeting is available as below (Most of the presentation materials are in Japanese).

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, Sendagi Shibuya-ku, Tokyo, Japan
Date
December 2, 2010 10:00 a.m.-4:40 p.m.

Program ICH Japan Symposium 2010 (69KB)

Side-scrollable

  Presentation materials Speakers

 

00_Welcoming Address(42KB)

Kohei Wada, JPMA

Session 1:ICH Topics

01_20 years of ICH (and beyond)(533KB)

Michiko Suzuki, MHLW

02_Overvew of ICH Topics(255KB)

Kurajiro Kishi, JPMA

Topics for the Electronic Exchange of Information

03_M2:Electronic Standards for the Transfer of Regulatory Information(250KB)

Takeshi Adachi, JPMA

04_E2B(R3):Data Elements for Transmission of Individual Case Safety Reports(364KB)

Ayumi Endo, MHLW(PMDA)

05_M5:Data Elements and Standards for Drug Dictionaries(472KB)

Izumi Oba, MHLW(PMDA)

06_M8(eCTD):Electronic Common Technical Document(283KB)

Koji Shomoto, JPMA

Efficacy Topics

07_E2C(R2):Periodic Benefit-Risk Evaluation Report(178KB)

Okudaira Tomoko, MHLW(PMDA)

08_E14 IWG:Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs:(154KB)

Maki Ito, JPMA

Safety Topics

09_S6(R1):Preclinical Safety Evaluation of Biotechnology Derived Pharmaceuticals(297KB)

Kazuto Watanabe, JPMA

10_S10:Photosafety Evaluation(333KB)

Dai Nakae, MHLW(TMIPH)

11_M3(R2) IWG:Revision of Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals(169KB)

Fumio Sagami, JPMA

12_M6, GTDG:Virus and Gene Therapy Vector Shedding and Transmission(606KB)

Wataru Toriumi, JPMA

13_M7:Genotoxic Impurities(869KB)

Masamitsu Honma, MHLW(PMDA)

Quality Topics

14_Q3D:Guideline for Metal Impurity(109KB)

Masayuki Mishima, JPMA

15_Q4B:Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions(244KB)

Masaaki Wada, JPMA

16_Q11:Development and Manufacturing of Drug Substances(165KB)

Kazunori Takagi, MHLW(PMDA)

17_Q-IWG:Quality Implementation Working Group(139KB)

Yoshihiro Matsuda, MHLW(PMDA)

Special Session: Pharmacovigilance

18_PV panel 1: Summary(376KB)

Daisaku Sato, MHLW

19_PV panel 2: Industry(173KB)

Yoko Hattori, JPMA

20_PV panel 3: Regulatory(133KB)

Tomoko Okudaira, MHLW(PMDA)

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