Global pharmacovigilance management

Key considerations in adopting global management scheme and systems in a borderless age

Establishing a global PV management scheme enables firms to realize the primary objective of PV operations, which is to maximize patient benefit by promoting proper use of drugs and risk minimization. In the near future, PV will play a wider and more sophisticated role.

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Global pharmacovigilance management

It has been a decade since GVP guidelines were issued in Japan. In these years, the expected roles of drug safety management representatives have significantly changed. Furthermore, globalization of business requires pharmacovigilance (PV) operations to be managed globally. This article discusses keys to success in implementing a global PV management scheme from three points of view; (1) PV strategy development, (2) discussion model for PV management scheme, and (3) global PV system development.

※This report issued in September 2013.

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