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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 June 2016

The Committee focused on the broad spectrum of its responsibilities which cover all aspects of the risk management of the use of medicines. The PRAC’s full range of work includes pre-authorisation activities, such as the assessment of risk-management plans for medicines under evaluation, as well as post-authorisation activities, such as the evaluation of periodic safety update reports (PSURs) to re-assess the benefit-risk balance of a medicine throughout its lifecycle on the basis of new data collected. The PRAC also evaluates safety signals, a key public-health function that ensures that new or changing safety issues are rapidly detected, evaluated and, when appropriate, product-labelling changes or restrictions are introduced for the benefit of patients.

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