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The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. The...
El modulo VII de las GVP define como se debe realizar un PSUR, con el fin de actualizar el balance r...
According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already impleme...
A Risk management plan is a document based on safety profile of medicines that collects all pharmaco...
Critical discussion addressing the current benefit/risk balance for the product on the basis of a co...
