EMA - workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use

20th June 2023

EMA - workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use

26th and 27th June 2023

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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