ICH Project 28th ICH Public Meeting
August 5, 2013
To share information on ICH activities and their progress with the general public, including representatives from companies responsible for drug development and safety assurance, the 28th ICH Immediate Report Meeting was held as a forum for reporting on and discussing the outcomes of the ICH Brussels Meeting(June 1–6, 2013, Brussels, Belgium), the 28th ICH Public Meeting was held on July 26, 2013, at Tsuda Hall in Tokyo.
At this briefing, a general report on the latest ICH trends was presented first, followed by reports and Q&A sessions led by experts on topics related to electronic standards for the transmission of pharmaceutical regulatory information, safety, and quality.
The program, presentation schedule, and presentation materials for this symposium are attached below and can be viewed directly. Please note that unauthorized copying or reproduction of the attached materials is prohibited.
Date, Time, and Venue
| Date and Time | Venue |
|---|---|
| Friday, July 26, 2013, 10:00 a.m. – 4:00 p.m. | Tsuda Hall , 1-18-24 Sendagaya, Shibuya-ku, Tokyo |
Information and Program
Event Information / Program (386KB)
Presentation Materials
| Presentation | Speakers | |
|---|---|---|
|
| Hironobu Saito (Daiichi Sankyo) | |
|
| Kurajiro Kishi (JPMA) | |
| Trends in Topics Related to Electronic Standards for the Transmission of Pharmaceutical Regulatory Information | 03_E2B (R3) Data Elements for Transmitting Individual Case Safety Reports (567KB) | Ayumi Endo (NIH) |
| Akiyo Fujikawa (Daiichi Sankyo) | ||
| Trends in Safety-Related Topics | Shigeru Hisada (Asuka Pharmaceutical) | |
| Hiroshi Nakae (Tokyo Metropolitan Institute of Public Health) | ||
| Trends in Quality-Related Topics | Masayuki Mishima (Chugai Pharmaceutical) | |
| 08_Q7: Active Pharmaceutical Ingredient (API) GMP Q&A (710 KB) | Tetsuhito Takarada (Mochida Pharmaceutical) |