Technical workshop on real-world metadata for regulatory purposes

Date: 12/04/2021
Location: Online

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 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:

  • 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.



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