Abstract by Haoxin Le

How can safety concerns be detected and evaluated more rapidly after a drug enters the market? 

This PhD project addressed this question by examining how post-marketing safety signals for antidiabetic medicines are assessed by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee(PRAC) and whether nationwide healthcare data can support earlier and more systematic safety evaluations. Using Danish real-world data, the studies evaluated active surveillance approaches for adverse events related to newer antidiabetic medicines. The findings show that these methods can produce results consistent with traditional pharmacoepidemiologic studies while enabling earlier detection and quantification of safety signals. Overall, the thesis demonstrates the added value of active surveillance in supporting timely medicine safety assessment, complementing pharmacovigilance systems.