Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 September 2018

News 07/09/2018

At its monthly meeting, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) did not start or conclude a new referral. More information on all safety reviews currently under evaluation is provided in the table below.

PRAC elects new vice-chair

The Committee elected Dr Martin Huber from Germany as the new vice-chair to take over from Dr Álmath Spooner. Dr Spooner has served for two three-year mandates, the maximum allowed by the legislation. EMA would like to thank Dr Spooner for the dedication and knowledge that she put at service to ensure the safety of medicines in the European Union. Dr Huber is Head of the unit 'PRAC, Legal Status, Adverse Reaction Reports, Medication Errors' at the BfArM (Federal Institute for Drugs and Medical Devices), in Germany. He has been a member of the PRAC since its inception in 2012.

This month, the PRAC also focused on the broad range of its responsibilities which cover all aspects of the risk management of the use of medicines. 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 at the beginning of October.


PDF icon Agenda - PRAC draft agenda of meeting 3-6 September 2018


Ongoing referrals

Procedure Status Update
Article-31 referral: Quinolone- and fluoroquinolone-containing medicinal products Under evaluation PRAC continues its assessment
Article-31 procedure: Methotrexate containing medicinal products Under evaluation PRAC continues its assessment


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