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Pharmacovigilance of biologics

In 2014, the Escher project “Pharmacovigilance of biologics” has been launched in the Netherlands to address the challenges of product and batch traceability of biological medicinal products in clinical practice and adverse drug reaction reporting. With financial support of the European Biopharmaceutical Enterprises (EBE), Escher established a collaboration between the Royal Dutch Pharmacists Association (KNMP), the Dutch Association of Hospital Pharmacists (NVZA) and the Netherlands Pharmacovigilance Centre Lareb.


Working within community and hospital settings, Exon Consultancy has evaluated systems and practices in the Dutch hospital setting for tracking biological product information and processes for reporting adverse drug reactions. Additional analyses were performed by Utrecht University to estimate the potential impact of exposure misclassification during ADR reporting on safety signal detection for biologics. Results were presented in a number of journal publications presenting valuable new insights into the ADR reporting processes of biologics.

More information about the project can be found here.

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