Regulatory Focus™ > News Articles > EMA Appoints Leaders of Newly-Formed Pharmacovigilance Committee

EMA Appoints Leaders of Newly-Formed Pharmacovigilance Committee

Posted 07 September 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) has announced the appointment of the chair and vice chair of its newest committee, the Pharmacovigilance Risk Assessment Committee (PRAC), which is set to oversee newly implemented pharmacovigilance measures in the EU.

The PRAC was formed to replace the now-defunct Pharmacovigilance Working Party (PHVWP). In a July statement, EMA said the PHVWP had completed its original charge, which was in its possession since the agency's founding in 1995, to provide advice on the safety of medicines.

The PRAC will now assume those duties and a host of new ones given to it under recent pharmacovigilance legislation. EMA said in a statement that the committee is likely to take a more active role in the protection of public health than did its predecessor.

The committee is set to be led by Dr. June Munro Raine, director of vigilance and risk management of medicines at the UK's Medicines and Healthcare products Regulatory Agency (MHRA). Serving as vice-chair will be Dr. Álmath Máire Spooner, manager of vigilance assessment for the Irish Medicines Board (IMB). Both Raine and Spooner previously served on the PHVWP, but they seem to be unique in this regard. Other members of the PRAC-a list of whom was published in July 2012 by EMA-have no prior experience serving on the PHVWP.


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