Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 December 2014

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05/12/2014

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 December 2014

PRAC held its last meeting for this year between 1-4 December 2014

During its December meeting, the PRAC did not initiate or conclude a safety referral. 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. A summary of recommendations on safety signals is made public two weeks following the PRAC meeting.

Information on all topics discussed by the PRAC is available below in the agenda for the meeting. A record of the discussions held this week will be provided in the minutes of this meeting, which will be published following the next PRAC meeting in January 2015.

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Related information

Contact point:

Monika Benstetter
Tel. +44 (0)20 3660 8427
E-mail: press@ema.europa.eu