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    PRAC meeting

    09.05.2017
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    The Pharmacovigilance Risk Assessment Committee (PRAC) is the European Medicines Agency's (EMA) committee responsible for assessing and monitoring safety issues for human medicines.

    The PRAC is responsible for assessing all aspects of risk management of human medicines, including:

    • detection, assessment, minimisation and communication of the risk of adverse reactions, while taking into account the therapeutic effect of the medicine;
    • design and evaluation of post-authorisation safety studies;
    • pharmacovigilance audit.

    The PRAC’s recommendations are considered by the Committee for Medicinal Products for Human Use (CHMP) when adopting opinions on centrally authorised medicines and referral procedures, and by the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) when providing a recommendation on the use of a medicine in the Member States.

    The Committee was established in 2012. Its members and alternates are nominated by corresponding National Competent Authorities. They are chosen based on the level of their qualifications and expertise in pharmacovigilance matters and risk assessments of medicines for human use. To represent healthcare professionals and patient organisations, the European Commission appoints two members and two alternates following consultation with the European Parliament. The European Commission also appoints six independent scientific experts.

    The joint Strategic Review and Learning Meeting of CHMP and PRAC will take place in Radisson Blu Hotel Olümpia, Tallinn, October 17-18.