ICH Project ICH Japan Symposium 2015 ICH Japan Symposium 2015

Aug 05, 2015

(32nd ICH Instantaneous Report Meeting)

ICH Japan Symposium 2015, a regional meeting of ICH in Japan, was held on July 23, 2015 at All Dentsu Hall in Tokyo to share information on the progress and activities of ICH with the general public, including companies in charge of drug development and safety assurance. The symposium was held on July 23, 2015 at the Dentsu Hall in Tokyo.

The symposium began with a general report on the latest developments in ICH Reform as the future of ICH, followed by reports and Q&A sessions on trends in the topics of electronic standards for the communication of regulatory information, safety, efficacy, and quality, presented by experts from each topic working group.

The symposium was attended by over 300 participants, and discussions were moderated by the chairpersons of each of the topic working groups.

The program, timetable, and presentation materials of the symposium are attached below for your direct viewing.
Unauthorized copying or reproduction of the attached materials is strictly prohibited.

Date, time and place

Date and Time Location
Thursday, July 23, 2015, 10:00-16:35 All Dentsu Labor Hall (All Dentsu Hall)
3-6 Kanda Surugadai, Chiyoda-ku, Tokyo

Information and Program

Information/Program (328KB)

Presentation materials

Horizontal scrolling is available

  Presentation Speaker
The Future of ICH: ICH Reform 01_Update on ICH Reforms（223KB) Toshiyoshi Tominaga (Japan Science and Technology Agency)
02_ICH Update in Fukuoka（316KB) Hironobu Saito (Daiichi Sankyo)
Trends in Topics on Electronic Standards for Communication of Drug Regulatory Information 03_M2 Electronic Standardization of Communication of Regulatory Information for Medicinal Products (767KB) Katsuhiro Hashimoto (Dainippon Sumitomo Pharma Co., Ltd.)
04_M8 eCTD Electronic Application Form (450KB) Taku Watanabe (NIH)
Trends in Safety Topics 05_S3A IWG Q&A Toxicokinetics Microsampling (313KB) Yoshiro Saito (National Institute of Health Sciences)
06_S5(R3) Reproductive and Developmental Toxicity Test Methods for Drugs (Revised) (236KB) Michio Fujiwara (Astellas)
07_S9 IWG Q&A Guidelines for Non-clinical Evaluation of Antineoplastic Agents (304KB) Dai Nakae（Tokyo Univ. of Agr.)
08_S11 Non-clinical safety study guideline using juvenile animals (272KB) (in Japanese) Kiyoshi MATSUMOTO (Takeda Pharmaceutical Company Limited)
09_M7 Evaluation and management of addendum DNA-reactive (mutagenic) impurities (534KB) Masamitsu Homma (National Institute of Health Sciences)
Trends in Efficacy Topics 10_E6(R2) Good Clinical Practice (GCP) (272KB) Satoshi Matsushita (Janssen Pharma)
11_E9（R1）Statistical Principles for Clinical Trials (Revised) (599KB) Satoru Tsuchiya（Dainippon Sumitomo Pharma Co.)
12_E11(R1) Pediatric clinical trials (revised) (316KB) Katsuaki Sato（GlaxoSmithKline)
13_E14 Clinical evaluation of QT/QTc interval prolongation and potential proarrhythmic effects in non-antiarrhythmic drugs (358KB) Kaoru Shinagawa (Natl.)
14_E17 Multinational collaborative clinical trial (MRCT) (738KB) Yoko Aoi (Natl.)
15_E18 Genomic sampling (386KB) Akihiro Ishiguro（National Institute for Health Sciences)
16_M4E(R2) Benefit-risk assessment (343KB) Yukiko Watanabe (Chugai Pharmaceutical)
Trends in Quality Topics 17_Q3C（R6）Maintenance Residual Solvent Guidelines for Pharmaceuticals (186KB) Akihiko Hirose（National Institute of Health Sciences)
18_Q7 IWG API GMP Q&A (786KB) Tetsuhito Takarada（Mochida Pharmaceutical Co.)
19_Q11 Development and Manufacturing of Active Pharmaceutical Ingredients Q&A（124B) Kenji Ozaki (Shionogi)
20_Q12 Management of pharmaceutical product life cycle (349KB) Yasuhiro Kishioka (Natl.)

The End

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