New Strategy for Pharmacovigilance Using Data-Mining Methods in Pharmaceuticals and Medical Devices Agency
10.3820/jjpe.15.23
- VernacularTitle:医薬品医療機器総合機構におけるデータマイニング手法導入後の市販後安全対策業務
- Author:
Chieko ISHIGURO
;
Satoru NAKAMURA
;
Kazuhiro MATSUI
- Publication Type:Journal Article
- Keywords:
data mining methods;
signal detection;
spontaneous reporting system
- From:Japanese Journal of Pharmacoepidemiology
2010;15(1):23-30
- CountryJapan
- Language:Japanese
-
Abstract:
During FY 2004 through 2008, as one of the projects in the first medium term plan, the Pharmaceuticals and Medical Devices Agency(PMDA)had been engaged in the research and establishment of data mining method as an operational support tool to assist staff in charge of post-marketing safety measures, with the goal to implement this tool in April 2009.
This article was written with objective to demonstrate the current operation process of data mining in PMDA.
