Please login to the form below

Not currently logged in
Email:
Password:

MHRA's Dr June Raine to chair new EMA pharmacovigilance committee

Pharmacovigilance Risk Assessment Committee (PRAC) will lead implementation of reforms

MHRA EMA PRAC Dr June RaineThe 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.

10th September 2012

From: Regulatory

Share

Tags

Subscribe to our email news alerts

Featured jobs

PMHub

Add my company
Research Partnership

Research Partnership, an Inizio Advisory Company, is a world-leading custom and syndicated global insights partner for health and life science...

Latest intelligence

Data security
Concerns about data security are building a strong case for clinical mobility in EMEA
Electronic medical records have transformed the storage of sensitive information but how can the healthcare sector continue to protect patient and staff data?...
Mainimage2
The role of digital health technology tools in supporting medical adherence
How DHT-based digital interventions can help to support patients and improve adherence...
How To Tell A Better Silent Story
They say a picture's worth 1,000 words, which is incredibly helpful when telling a silent story....