The Big Data Steering Group set up by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) has published its first workplan which sets actions to be delivered in 2020-21. The workplan aims to progress evolution to data-driven regulation through smart working, leveraging international collaboration with stakeholders and the use of remote expert workshops. The increase of the utility of big data in regulation from the quality of data through study methods to assessment and decision-making is amongst its goals.
The work carried out by the Big Data Steering Group builds on the Regulatory Science Strategy to 2025, published in March 2020, and will support the European Medicines Agencies Network Strategy to 2025, currently under development.
The European Medicines Regulatory Network has to prioritise the unprecedented public health challenge of the COVID-19 pandemic and implementation of the Big Data Steering Group workplan will need to be flexible and certain actions may need to be re-scheduled depending on the development of the pandemic.
Big data can complement the evidence from clinical trials and fill knowledge gaps on a medicine, and help to better characterise diseases, treatments and the performance of medicines in individual healthcare systems. For more information on big data, please click here.