Multi-stakeholder workshop on Real World Data (RWD) quality and experience in use of Real World Evidence (RWE) for regulatory decision-making

Date: 26/06/2023 to 27/06/2023
Location: European Medicines Agency and online

Event summary

Building upon the experience of the submission of real-world evidence for regulatory purpose and the conclusions of previous activities around data standardisation, metadata, data quality and DARWIN EU®, this workshop aims to:

  • Discuss important challenges related to measuring and characterising data quality in the context of RWE generation.
  • Familiarise stakeholders with the approach used in drafting of considerations on Real-World Data linked to the EU Data Quality Framework.
  • Discuss recent use of RWE in the regulatory context and share lessons learned.
  • Look back at the European Medicines Regulatory Network response to the COVID-19 pandemic and reflect on learnings and impact on the way we use RWE to address public health emergencies.
  • Collect input from experts in the field and learn from existing experiences.
  • Get multi-stakeholders’ input to identify ways to enable further use and continue to establish the value of RWE in regulatory processes.

Live broadcast - 26 June: 13:00 - 17:45 (CEST), 27 June: 09:00 - 16:10 (CEST)

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