EMA Names PRAC Chair, Vice Chair

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 07-21-2015 10:58


At its July 2015 meeting, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) voted to prolong the mandates of Dr. June Raine and Dr. Álmath Spooner as chair and vice-chair, respectively. Both of their terms have now been prolonged by another three years, beginning in September 2015. The PRAC is the Committee at the EMA responsible for assessing all aspects of the risk management of medicines for human use. The committee was formally established in July 2012 as a central pillar of the new EU pharmacovigilance legislation.

Dr Raine is director of Vigilance and Risk Management of Medicines at the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK. She has served as chair of the PRAC since September 2012. Looking ahead, Dr Raine sees three key priorities for the PRAC: to evaluate the outcome of its pharmacovigilance activities and decisions in terms of measurable public health benefit; to ensure pharmacovigilance and risk management systems are key enablers of earlier access for patients to innovative medicines; and to continue to progress the way in which the PRAC engages with healthcare professionals, patients and the public to deliver regulatory decisions.

Dr Spooner is pharmacovigilance and risk management lead at the Health Products Regulatory Authority in Ireland. As Vice-chair of the PRAC since 2012, she has supported Dr Raine in leading the committee.

Source: European Medicines Agency


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