Pharmacovigilance Risk Assessment Committee confirms Chair and Vice-chair for new three year mandate

News 17/07/2015

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.

Dr June RaineDr Raine (Chair, pictured) 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, providing exceptional leadership to the Committee in its inaugural years.

“It has been an enormous privilege to work with such a dedicated and talented group of scientists, regulators, healthcare professionals and patient representatives, from the first establishment of the PRAC three years ago,” Dr Raine said, when she accepted her prolonged term.

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.

“This is a truly exciting time for the Committee and I relish the opportunity to be part of leading this great initiative to better protect EU public health, to the high standards which every EU citizen can rightly expect,” Dr Raine said.

Dr Almath SpoonerDr Spooner (Vice-chair, pictured) 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, bringing considerable expertise in assessing and monitoring safety of medicines to her role.

The PRAC is the Committee at the European Medicines Agency 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.

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