In 2012, the European Medicines Agency published guidelines for good pharmacovigilance practices. Within these guidelines, the Agency advised that marketing authorization holders (MAHs) establish safety signal tracking systems that capture outcomes related to signals that have been validated. Historically, MAHs have collected data and information to document signal detection and evaluation activities, and now many are developing robust approaches, to meet the guidelines, that systematically track and manage signals. Given the requirements, these systems could become highly reliant on business intelligence (BI) solutions. Expectations for these systems include the ability to document and track safety signals electronically through each step of the signal detection process, save source documents, and collect key performance indicators. They also include the ability to extract this information programmatically for regulatory or senior management reporting as well as for monitoring of compliance metrics. In addition, this type of systems-based approach facilitates resource management and assists MAHs to be regulatory inspection and audit ready. This article shares an experience of one mid-size pharmaceutical company.

dx.doi.org/10.1007/s40290-015-0107-5, hdl.handle.net/1765/88017
Pharmaceutical Medicine
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Department of Medical Informatics

Patadia, V.K, Nimke, D, Stefansdottir, G, Benjoya, J, Allard-Schrijer, L, Holbrook, C, … Saccomanno, C.F. (2015). A Business Intelligence Solution to Pharmacovigilance Signal Tracking and Management: One Mid-Size Pharma’s Experience. Pharmaceutical Medicine, 29(4), 197–201. doi:10.1007/s40290-015-0107-5