RWE 201 – EU – EMA Big Data Steering Group Updates Its Workplan to Accelerate Transformation to Data-Driven Medicines Regulation

Updated EMA Big Data Steering Group Workplan:

The Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA) Big Data Steering Group workplan has been enhanced including work on national regulatory use cases for real-world evidence (RWE), intensified work on artificial intelligence (AI) and public consultation on patient experience data (PED).

The updated Big Data Steering Group (BDSG) workplan continues to evolve to integrate use of big data and data analytics in medicines regulation. he updated workplan contains the following key additions:

[1] Real-world evidence (RWE): DARWIN EU® will address use cases from national regulators and learnings from RWE pilots will be gathered and published.  Work on RWE guidance, at EU and international level, will be informed by public consultations and collaboration with international regulators under the umbrella of ICH will continue.

[2] Real World Data (RWD) quality considerations will be published following a public consultation.

[3] Engagement with patients’ organisations will intensify through a public consultation on Patient Experience Data (PED), dialogue on training needs, workshop on patient registries, a call to populate the metadata and RWD source catalogues with PED, and exploration of use cases to analyse PED to establish their role in regulatory decision-making process.

[4] Analysis of additional data types will be explored with the development of use cases for genomics data, the launch of a ‘proof of concept’ on non-clinical raw data analysis and discussion on Chemistry, Manufacturing and Controls (CMC) data analysis.

[5] Experimentation of advanced analytics, including AI, will continue and the first AI knowledge mining tool for core regulatory processes will be released to the EU regulatory network.

[6] The future European Medicines Regulatory Network data strategy will be developed to prepare for publication in 2025.

A full overview of the timeline can be found here:

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