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Pharmacovigilance Risk Assessment Committee

Date(s) - 11/07/2016 - 13/07/2016

Austria Trend Hotel

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The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring safety issues for human medicines. The PRAC meets at the European Medicines Agency (EMA). The committee has been established in 2012. The PRAC’s recommendations are considered by the Committee for Medicinal Products for Human Use (CHMP) when it adopts opinions for centrally authorised medicines and referral procedures, and by the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) when it provides a recommendation on the use of a medicine in Member States.