EMA - Technical workshop on real-world metadata for regulatory purposes

23rd February 2021

On behalf of the HMA-EMA Big Data Steering Group we are pleased to inform you of the upcoming “Technical workshop on real-world metadata for regulatory purposes” on Monday, 12 April 2021.

Data characterization and discoverability are goals for the scientific community and for medicines regulation. The HMA-EMA joint Big Data Task Force recommended “to promote data discoverability through the identification of metadata” as part of its Recommendation III, which is reflected in the Big Data Steering Group work plan.

The objective of this workshop is to review and gather stakeholders’ feedback on a: 

·         preliminary list of metadata required for characterising real-world data sources, and their definitions;

·         proposed process to collect and maintain metadata from real-world data sources;

·         proof-of-concept catalogue of data sources and metadata currently being developed.

The above items are being developed by the MINERVA Consortium (Metadata for data discoverability and study replicability in observational studies) as part of the EMA-funded project Strengthening Use of Real-World Data in Medicines Development.

The workshop will be held as a virtual meeting. We anticipate space for a broad representation of stakeholders, and attendance will be organised through EU associations and by direct invitation. 

To enable wide engagement, we plan to broadcast the workshop on the Internet.

An outline of the agenda and details on the registration process will be available shortly.

More information on this project can be found on EU Big Data webpage. 

Should you have any questions on the upcoming workshop, please contact metadata@ema.europa.eu.

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