The Role of Signal Detection in Pharmacovigilance

The World Health Organisation defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. Signal detection is a core pharmacovigilance activity. The motivation behind exploring signal detection and evaluation process is the timely detection of safety issues, and ultimately a better protection of public health. This thesis aimed to explore the processes of signal detection and evaluation and to inform regulatory decision making by providing evidence-based solutions to some of the existing questions. We investigated methods of detection and alternative data sources. Furthermore, we were interested to find out which characteristics of drugs make them more prone to have safety issues discovered post-marketing and tried to find predictive characteristics and we tried to gain some insight in the prioritisation process. The current work is relevant for all involved stakeholders, as European Medicines Agency (EMA), national regulatory authorities, pharmaceutical industry and, healthcare professionals and researchers.

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