The European Medicines Agency’s recently established Pharmacovigilance Risk Assessment Committee (PRAC) has elected June Raine (pictured) from the United Kingdom (UK) as its chair and Álmath Spooner from Ireland as its vice-chair at its second meeting from 3 to 5 September 2012. Both mandates are for a three-year period.
“The PRAC is set to play a pivotal role in delivering the public health benefits of the new European pharmacovigilance legislation,” said Dr Raine on accepting her election. “My ambition is to make sure that this unique opportunity to strengthen public health protection is fully realised for the benefit of all citizens in the European Union.
The new legislation provides powerful tools to strengthen the protection of public health in Europe and the effective use of these tools will depend on clarity of vision, strong leadership, sound scientific judgement and excellent communication by the PRAC.”
Over the course of her career, Dr Raine has made outstanding contributions towards delivering a world-class European Union pharmacovigilance system. Together, she and Dr Spooner bring a wealth of experience in medicine, pharmacy, regulation of medicines and public health protection through pharmacovigilance and risk-management of medicines to their new roles.
New levels of transparency
The PRAC operates with a high level of transparency. The agendas for the meetings will be systematically published on the Agency’s website ahead of the meeting and the detailed outcome will be made available in meeting minutes, which will be published after their adoption at the following PRAC meeting.
- – Dr June Raine is Director of Vigilance and Risk Management of Medicines at the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, a post she has held since 1999. She qualified in medicine at Oxford University, and also has a Master of Science in pharmacology. June Raine: Scientific profile
- – Dr Spooner is Vigilance Assessment Manager, Human Products Monitoring Department, at the Irish Medicines Board. She qualified in pharmacy at Trinity College Dublin and also holds post-graduate qualifications in pharmacy, statistics and pharmaceutical medicine. Álmath Spooner: Scientific profile
- – Dr Raine and Dr Spooner were both members of the Agency’s former Pharmacovigilance Working Party. From 1995 until July 2012, when it ceased to exist, the working party was responsible for providing advice on the safety of medicines and on the investigation of adverse reactions associated with medicines authorised in the EU.
- – The minutes of the PRAC’s September 2012 meeting will be published following their adoption at the PRAC’s October meeting.