DIA-MHRA Global Summit

SESSION OVERVIEW: The UK has a unique opportunity to use health data as a strategic advantage for clinical trials, drug development, regulation and patient safety. Its strength lies both in routinely collected clinical data, including longitudinal electronic health records, prescribing, hospital and outcomes data, and in complementary granular, specifically collected research datasets, cohorts and biobanks, including world-class assets such as UK Biobank. Together, these resources create a powerful platform for designing smarter trials, understanding patient populations and generating evidence across the product lifecycle.

This session will examine how health data and AI can unlock more innovative development while enhancing our ability to detect, understand and act on safety signals earlier. Regulators can help advance these approaches by setting clear expectations for data quality, transparency and methods; supporting early scientific advice and qualification of novel evidence approaches and outcome measures; and creating trusted pathways for using real-world data and AI-enabled evidence in decision making. By investing in secure data integration, common standards, trusted governance and clear regulatory routes, the UK can turn its data strengths into a globally competitive capability that accelerates innovation and supports better, safer outcomes for patients.

SESSION IMPACT:This session will move the conversation from data potential to practical impact. Attendees will gain a clearer view of how the UK can harness linked health data, advanced analytics and AI to generate better evidence, accelerate smarter medicines development, and strengthen regulatory and safety decisions. The discussion will highlight the practical role regulators can play in creating confidence, setting standards and opening routes for trusted use of real-world and AI-enabled evidence. Participants should leave with a clear sense of how the UK can use its exceptional data assets to support innovation, improve access and deliver better, safer outcomes for patients.