Defining And Improving Data Quality In Pharmacovigilance: A Step Towards Generating Robust Evidence

Pharmacovigilance is an essential component of pharmaceutical safety [1]. This science can be defined as all activities relating to detecting, assessing, understanding and preventing adverse effects or any other medicine-related problem [2]. When addressing drug surveillance issues, adverse reactions are undoubtedly the most significant source of concern with medicines. According to Guideline on Good Pharmacovigilance Practices, an adverse drug reaction (ADR) can be defined as "a response to a medicinal product which is noxious and unintended" [2]. In contrast to an adverse event, an ADR is characterised by the causal relationship between a medicinal product and an occurrence is suspected