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Abstract: This presentation will provide an overview of the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) work on high-fidelity synthetic data applications with a focus on data augmentation to address biases due to underrepresentation of population subgroups and boosting small sample sizes in the context of clinical trials. The presentation will also include a brief overview of the MHRA’s approach to synthetic data generation and evaluation as well as our emerging thinking on good practice in this area.