ICH Project ICH Japan Symposium 2010

December 22, 2010

ICH Japan Symposium 2010 (The 23rd ICH Immediate Report Meeting)
ICH Public Meeting: ICH Japan Symposium 2010

As a forum for presentation and discussion of the outcomes of the ICH Fukuoka Meeting (November 6-11, 2010, Fukuoka, Japan), the third ICH regional meeting in the Japan region was held on December 2, 2010 at Tsuda Hall, Tokyo, under the title "ICH Japan Symposium 2010".

The symposium was held with the following program. In Part I, presentations and discussions on the progress and achievements of the Expert Working Groups at the Fukuoka Conference were made as trends in each topic. In Part II, a special session, a general discussion on pharmacovigilance was held with the participation of experts from both the business and government sides. This session included a comprehensive discussion on E2-related guidelines (E2A, E2B, E2D, E2E, and E2F), including the Periodic Safety Update Report (PSUR) for E2C marketed drugs, and gaps among regions and guidelines.

The program, timetable, and presentation materials for this symposium are attached below for your direct viewing.

In addition, the workshop materials on "Trends in Quality Topics: Q-IWG Quality Implementation Working Group" are available at the ICH Q8, Q9, and Q10 Guidelines Operational Practices Workshop.

Unauthorized copying or reproduction of the attached materials is strictly prohibited.

Date, time and place

Date and Time Location
Thursday, December 2, 2010, 10:00-16:40 Tsuda Hall
1-18-24 Sendagaya, Shibuya-ku, Tokyo

Information and Program

Presentation materials

Horizontal scrolling is available

  Presentation Speaker
  00_Opening Remarks(42KB) Kouhei Wada (Daiichi Sankyo)
Part I: Topic Trends 01. History of ICH (533KB) Riko Suzuki (Ministry of Health, Labour and Welfare)
02_ICH Latest Trends (255KB) Kurajiro Kishi (Pharmaceutical Manufacturers Association of Japan)
Trends in Topics on Electronic Standards for Communication of Drug Regulatory Information 03_M2: Electronic Standardization of Communication of Regulatory Information for Medicinal Products (250KB) Takeji Adachi (Janssen Pharma)
04_E2B (R3): Data items and message specifications for transmitting individual case safety reports (364KB) Ayumi Endo (NIH)
05_M5: Data items and standards for drug dictionaries (472KB) Izumi Ohba (NIH)
06_M8 (eCTD): Electronic application form (283KB) Koji Shomoto (Nippon Boehringer Ingelheim)
Trends in Efficacy Topics 07_E2C (R2): Periodic post-marketing safety report (178KB) Tomoko Okudaira (NIMS)
08_E14 IWG: Clinical evaluation of QT prolongation and serious arrhythmia (154KB) Maki Ito (Shionogi)
Trends in Safety Topics 09_S6(R1): Non-clinical safety evaluation of biopharmaceuticals (review) (297KB) Kazuto Watanabe (Chugai Pharmaceutical)
10_S10:Photo safety study (333KB) Dai Nakae(Tokyo Metropolitan Institute of Public Health)
11_M3(R2) IWG: Timing of Non-clinical Studies (169KB) Fumiro Sagami (Eisai)
12_M6, GTDG: Viral/vector shedding and propagation, gene therapeutic drug discovery group (606KB) Goh Toriumi (POC Clinical Research)
13_M7: Evaluation and Management of DNA Reactive Impurities (869KB) Masamitsu Homma (Eiken)
Trends in Quality Topics 14_Q3D: Metal Impurities (109KB) Masayuki Mishima (Chugai Pharmaceutical)
15_Q4B: Evaluation and Recommendations for Inter-Use of Pharmacopoeia Texts in the ICH Region (244KB) Masaaki Wada (Shionogi)
16_Q11: Development and Manufacture of Active Pharmaceutical Ingredients for Chemicals and Biopharmaceuticals (165KB) Kazunori Takagi (General Pharmaceuticals Organization of Japan)
17_Q-IWG: Quality Implementation Working Group (139KB) Yoshihiro MATSUDA (National Institute for Health Sciences)
Part II: Special Session Pharmacovigilance 18_PV Panel 1: Summary (376KB) Daisaku Sato (Ministry of Health, Labour and Welfare)
19_PV Panel 2: Industry side (173KB) Yoko Hattori (Daiichi Sankyo)
20_PV Panel 3: Administrative side (133KB) Tomoko Okudaira (NIMS)

The End

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