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A Pharmacovigilance System Master File is a document describing the pharmacovigilance system used by the marketing authorisation holder (MAH) with respect to one or more authorized medicinal produc
A detailed description of the set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products including the assess
A Safety Data Exchange Agreement is a legal written contract which ensures that all safety data regarding a medicinal product makes its way quickly and reliably back to the marketing authorisation
Adverse event (AE) means any untoward medical occurrence associated with the use of a drug or pharmaceutical product in humans, whether or not considered drug related.
MedWatch is the US Food and Drug Administration's reporting program for product complaints.
Signal detection process is a set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems o
The submission of data on medicines by marketing-authorisation holders into the EVMPD is a legal requirement from the
In order for health authorities to monitor the safety of investigational drugs, sponsors of clinical trials are required to submit safety reports of certain adverse events
A Post-Authorization Safety Study (PASS) is a study performed after the marketing authorization and aiming principally to further evaluate the safety of the medicinal product or to measure the effe
A Post-Authorization Efficacy Study (PAES) is a study performed after the marketing authorization and aiming principally to further evaluate the efficacy of the medicinal product.