Key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products

This document addresses the influence of pharmacogenomics on pharmacovigilance activities. It includes considerations on how to evaluate the pharmacovigilance related issues for medicinal products with pharmacogenomic associations, and how to translate the results of these evaluations to appropriate treatment recommendations in the labelling.

Keywords: Pharmacogenomics, pharmacovigilance, biomarkers, genomic variations

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