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Abstract

In the best interest of safeguarding public health, the science of pharmacovigilance has grown in importance over the last 30 years. In the mid-1980s, industry, academia, and regulators joined forces to improve the conduct of pharmacovigilance, which resulted in several important initiatives including CIOMS and the ICH process.

Multiple aspects of pharmacovigilance have been recognized and addressed within the legal framework that subsequently has created numerous requirements for pharmacovigilance in legislation internationally. Also, the day-to-day running of pharmacovigilance has developed into a very complex business process. In recognition of these issues and the increasing complexities of the global environment, a group of EU pharmacovigilance experts met in 2005 with the goal of discussing how to facilitate the understanding of pharmacovigilance specifically related to the conduct of good pharmacovigilance practices. Brainstorming created the outline of a document/textbook, the table of contents, and a description of the topics that should be covered for the book to become a comprehensive reference document of good pharmacovigilance practice for everyone interested in understanding or working in the field of pharmacovigilance.

Keywords

Pharmacovigilance Good pharmacovigilance practice Risk management Pharmacovigilance legislation Pharmacovigilance guidance

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