LAUSR

Drug use is associated with a certain degree of risk. The benefit risk balance is guarded throughout the whole drug life cycle, during the pre‐marketing development and testing, as well as after drugs have been approved for use in patients. Drug developers need to comply with rigorous guidelines set by regulatory agencies during the phases of drug development prior to their marketing to prove that these drugs are safe to use in patients. But as not all risks related to their use are known at the moment of marketing authorisation, there is still need for drug safety monitoring during the post‐marketing phase. The science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug‐ related problem in the post‐marketing phase is commonly referred to as Pharmacovigilance. The goal of pharmacovigilance is to reduce harm by more appropriate use of medicines. Pharmacovigilance activities aim to contribute to the protection and promotion of public health.