Abstract
Takeda Chemical Industries, Ltd. has established a comprehensive adverse events (AE) management system for all of its prescription drugs on the market. The system tracks, reports, alerts, and communicates (TRAC).
The TRAC system has been designed so that it satisfies the good postmarketing surveillance practice (GPMSP) requirements of the Japanese health authorities. Furthermore, it can cope with the internationalization of Takeda's overseas operations and can comply with other countries' regulations concerning adverse events reporting. With this system, data input and output can be done in both English and Japanese. Although descriptions of AEs use current Japanese adverse drug reaction terminology, they can also be converted to or output in WHO-ART and COSTART equivalents.
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