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