Technical workshop on real-world metadata for regulatory purposes
EventHumanData on medicines
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Date
- Δευτέρα, 12 Απρίλιος 2021, Ολοήμερο
Τόπος
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
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 Priority recommendations of the HMA-EMA joint Big Data Task Force, which is reflected in the Big Data Steering Group work plan.
The objective of this workshop is to review and gather stakeholders’ feedback on:
- preliminary list of metadata required for characterising real-world data sources and definitions to fulfil regulatory use cases;
- proposed options for metadata from real-world data sources collection and maintenance processes;
- proof-of-concept catalogue of data sources and metadata.