Graeme Tunbridge has been appointed interim Director of Devices. Graeme is currently the Group Manager for Devices Regulatory Affairs at the MHRA, and will take up his new post from 21 October 2019 following the retirement of John Wilkinson.
Graeme Tunbridge commented:
“I am delighted to have been asked to take on this role. It is a time of unprecedented change and challenge for the regulation of medical devices, both in the UK and globally. During this time, I want to ensure that the MHRA continues to strive to improve outcomes for patients and the public by driving continuous improvements in the safety, effectiveness and usability of medical devices.”
Dr Sarah Branch has been appointed interim Director of Vigilance and Risk Management of Medicines (VRMM). Sarah has been the Deputy Director and Head of Operations in VRMM for 6 years and took over as Director on 23 September 2019, following Dr June Raine’s appointment as the Agency’s interim Chief Executive.
Dr Sarah Branch commented:
“I am honoured to take up this role at this important time. I am looking forward to working with Dr Raine and fellow Directors as the Agency adapts to its new environment, whilst keeping patient safety as a highest priority.”
Graeme Tunbridge – biography and role
Graeme first joined the MHRA in 2011 and has spent much of his time negotiating, and now implementing, a package of measures to strengthen the regulation of medical devices.
Graeme has been a civil servant for 15 years and spent his early career working on healthcare policy. He has previously held Deputy Director roles at the Department of Health and spent 18 months as Private Secretary to the Secretary of State for Health.
He has a Master’s degree in biochemistry from the University of Oxford.
The Director of Devices leads the division in the Agency that is responsible for the operation of the regulatory framework that ensures the safety and performance of medical devices on the UK market. This includes:
- investigating reports of problems involving medical devices and taking action in response to these, such as advising healthcare professionals on the safe use of devices, working with manufacturers to improve device safety and, where needed, taking enforcement action
- reviewing proposals to undertake clinical investigations using medical devices on patients in the UK
- overseeing the UK notified bodies for medical devices, which are responsible for the pre-market assessment of higher-risk product
- ensuring the smooth operation of the regulatory framework, including the provision of regulatory advice
Dr Sarah Branch – biography and role
Sarah joined the Agency in 1994 after a career in academia. She brings a wealth of regulatory experience to the Director role having worked in both Licensing and Post-Licensing Divisions. In particular, Sarah has built a strong Paediatric Unit and over the last 10 years has helped deliver more authorised medicines for children.
Sarah is a Fellow of the Faculty of the Royal Pharmaceutical Society, Fellow of the Royal Society of Chemistry and Honorary Fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians.
The Director of Vigilance and Risk Management of Medicines has responsibility for pharmacovigilance of medicines, including the Yellow Card Scheme for reporting adverse drug reactions, benefit-risk assessment and updates to safety information.
VRMM Division is also responsible for renewal of authorisations, changes in legal classification and advertising of medicines, and for assessment of studies relating to the development of paediatric medicines.