NDPCHS Guest Lecture Series: Synthetic Data, AI, and Regulation: Insights from the MHRA
Thursday, 11 December 2025, 12.15pm to 1.15pm
Dr Myles will provide an overview of the MHRA’s research into high-fidelity synthetic data, including its use in the development of AI Medical Devices, particularly in the context of clinical trials.
Next in our Guest Lecture Series, we’re joined by Dr Puja Myles, Director, Clinical Practice Research Datalink, Medicines & Healthcare Regulatory Agency.
In her lecture, titled ‘Regulatory Considerations for the use of synthetic data in the development of AI medical devices’, Dr Myles will provide an overview of the MHRA’s research into high-fidelity synthetic data, including its use in the development of AI Medical Devices, particularly in the context of clinical trials. She will also give an overview of the MHRA Expert Working Group report which examined regulatory considerations when using synthetic data for the development of AI medical devices.
Dr Myles trained as a public health specialist and epidemiologist following her initial clinical training and practice. She was a public health academic working with real world data for many years before she joined the MHRA’s Clinical Practice Research Datalink. She is a fellow of the Faculty of Public Health (UK), a senior fellow of the Higher Education Academy (UK) and holds a PhD in Epidemiology.
St Luke's Chapel, Radcliffe Observatory Quarter, 35 Woodstock Road, Oxford, OX2 6GG
Step Free Access at St Lukes Chapel St Lukes Chapel | Access Guide