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MedWatch is the US Food and Drug Administration's reporting program for product complaints.
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.
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
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 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
The PSUR provides an evaluation of the risk-benefit balance of a medicinal product defined time points post-authorization.