On 14 September 2020 the Big Data Steering Group set up by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) has published its workplan, which sets actions to be delivered in 2020-21.
With the European Medicines Regulatory Network focused on the response to the COVID-19 pandemic, the workplan aims to progress evolution to data-driven regulation through smart working, leveraging collaboration with stakeholders and the use of remote expert workshops.
The workplan aims to increase the utility of big data in regulation, from data quality through study methods to assessment and decision-making. It is patient-focused and guided by advances in science and technology. The workplan highlights key topics of interest which include priority recommendations and key actions:
Stakeholders will have the opportunity to discuss the workplan and its implementation in the context of a virtual multi-stakeholder forum scheduled for late 2020.
The implementation of the workplan will be flexible and certain actions may be re-scheduled, since the European medicines regulatory network has to prioritise the unprecedented public health challenge of the Coronavirus disease (COVID-19) pandemic.
For more information read the full workplan