Healthy Skepticism Library item: 9179

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Sakurai Y, Kugai N, Kawana T, Fukita T, Fukumoto S.
Comprehensive adverse events management system for the pharmaceutical industry: Takeda Trac System
Drug Information Journal 1995; 29:(2):645-659

Abstract:

A comprehensive adverse events (AEs) computerized management system established by Takeda Chemical Industries, Ltd. for all of its prescription drugs on the market, which tracks, reports, alerts, and communicates (TRAC), is described. The TRAC system was designed to satisfy the good postmarketing surveillance practice requirements of the Japanese health authorities. It can also cope with the internationalization of Takeda’s overseas operations and can comply with other countries’ regulations concerning adverse events reporting. Data input and output can be done in both English and Japanese.