KAKEN PHARMACEUTICAL CO., LTD. ( headquarters: Bunkyo-ku, Tokyo; president: Shiro Inui ) has started operating a drug safety information management system, dubbed K-minds, in order to better manage PMS and other information related to the safety of its products.
The company started the construction of K-minds jointly with Fujitsu FIP Co.,Ltd. ( headquarters: Koto-ku, Tokyo; president: Takao Ikeda ) in June 2000 in order to make it possible to quickly answer questions and inquiries from medical institutions and other users of its products.
Major features of the new system include 1) function to download previous data, 2) function to download images, verify the contents on the PC and printout the data, 3) design to save spaces, 4) function to automatically download the literature and information from society meetings via electronic media, and 5) function to search for information to answer questions and inquiries.
KAKEN plans to upgrade the system and to deal with the ICH-E2b and MedDRA version control and to manage not only PMS data related to safety but also information on the safety of drug candidates under clinical development and information on efficacy.
Details of the system will be reported at the 122nd annual assembly of the Pharmaceutical Society of Japan.