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EMA's new pharmacovigilance committee holds first meeting

PRAC group will oversee implantation of overhaul to drug safety monitoring in Europe

The first two-day meeting of the European Medicines Agency's (EMA) newest working group, the Pharmacovigilance Risk Assessment Committee (PRAC), began yesterday in Brussels as the Agency initiated plans to avoid the London 2012 Olympics.

The EMA, which is based in Canary Wharf, London, has moved a large number of its operations to other cities during the course of the Games, including this inaugural gathering of the new committee it formed to oversee the overhaul of the system to manage the reporting and monitoring of drug safety in Europe.

“The establishment of the PRAC will make the existing system even more robust,” said Guido Rasi, executive director of the EMA, “as we will now have a dedicated committee responsible for assessing and monitoring safety issues for human medicines.”

The Committee's establishment is one of the main points of new European pharmacovigilance legislation that debuted at the beginning of July, 2012.

This legislation introduces new rules to governing the monitoring, identification and assessment of adverse events caused by pharmaceuticals, with the aim of making the EU-wide system for overseeing drug safety and 'benefit-risk' more transparent and robust.

Continuing today, the primary topic of the group's first meeting is the organisational aspects of the PRAC so that the group is ready to discuss medicines-related issues at its next meeting in September, 2012.

The agenda, which has been published online as part of new transparency measures implemented by the EMA, includes the discussion of draft rules of procedure for mandate membership and chairmanship, the voting process, PRAC tasks and the roles and responsibilities of the PRAC and EMA secretariats.

The group's members includes representatives from each EU member state, including June Munro Raine of the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and Martin Huber of Germany's  Federal Institute for Drugs and Medical Devices.

In addition, there are six independent scientific experts nominated by the European Commission (EC).

The EMA said: “[The] establishment of new European committee marks start of new era for public-health protection and transparency of medicines safety in Europe.”

In addition, the EMA also launched a video that sees the EMA's head of pharmacovigilance and risk management Dr Peter Arlett explain the new pharmacovigilance legislation.

20th July 2012

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