The EMA has extended the tenure of Dr June Raine as chair for its Pharmacovigilance Risk Assessment Committee (PRAC).
Dr Raine is director of vigilance and risk management of medicines at the Medicines and Healthcare products Regulatory Agency (MHRA) and has served as PRAC chair since it was set up in 2012.
The Committee was established as part of a raft of pharmacovigilance reforms that aimed to make the EU-wide system for overseeing drug safety and ‘benefit-risk’ more transparent and robust.
Dr Raine said: “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.
“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.”
Under her leadership Dr Raine said the PRAC would have three key priorities:
• Evaluating the public health benefits of its pharmacovigilance activities and decisions
• Ensuring pharmacovigilance and risk management systems act as key enablers of earlier access for patients to innovative medicines
• Continuing to improve its engagement with healthcare professionals, patients and the public.
Alongside Dr Raine the EMA has also extended the term of the PRAC’s vice-chair Dr Almath Spooner, who is also pharmacovigilance and risk management lead at the Ireland’s Health Products Regulatory Authority.