Pharmacovigilance (PV) plays an important role for patient safety through the collection, recording, analysis, monitoring and prevention of adverse effects with drugs and therapies. This extends to collecting and collating solicited and unsolicited reports of suspected adverse reactions associated with both investigational and marketed medicinal products for human use. One method of documenting these events is the Individual Case Safety Report (ICSR), which is “an individual report of suspected adverse reactions in relation to a medicinal product that occur in a single patient at a specific point of time.”1Download Now

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