The EMA’s new Pharmacovigilance Risk Assessment Committee (PRAC) has elected Dr June Raine as its chair for a three-year term.
She is director of vigilance and risk management of medicines at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), a role she had held since 1999.
The PRAC will lead implementation of the wide-ranging pharmacovigilance reforms the EMA brought in over the summer. Its oversight powers include compelling the regulator to hold open hearings where the public can discuss medicine safety issues.
Dr Raine said: “The PRAC is set to play a pivotal role in delivering the public health benefits of the new European pharmacovigilance legislation.
“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.”
The PRAC, which first met in July, also elected the Irish Medicines Board’s vigilance assessment manager, human products monitoring department Dr Almath Spooner at its September meeting to serve for three-years as vice-chair.
Dr Raine and Dr Spooner were both members of the Agency’s former Pharmacovigilance Working Party, which was wound up in July.