EMA workshop on real-world data quality and experience in use of real-world evidence for regulatory decision making

On June 26–27 2023, the European Medicines Agency (EMA) is holding an in-person and virtual 2-day workshop on the challenges and opportunities of using RWE in regulatory processes. The event, entitled ‘Multi-stakeholder workshop on Real-World Data (RWD) quality and experience in use of Real-World Evidence (RWE) for regulatory decision-making‘, will enable attendees to gain further understanding of the EMA’s experience of RWE for regulatory purposes as well as learn more about data standardization, metadata, data quality, and DARWIN EU®.

Workshop overview:

Day 1 – Monday, 26 June 2023, 12:30–17:55 CEST

• Familiarize stakeholders with the approach used in drafting of considerations on RWD linked to the EU Data Quality Framework
• Discuss important challenges related to measuring and characterizing data quality in the context of RWE generation

Day 2 – Tuesday, 27 June 2023, 08:30–16:10 CEST

• Discuss recent use of RWE including DARWIN EU in the regulatory context, collect input from experts in the field and learn from existing experiences
• 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
• Get multi-stakeholders’ input to identify ways to enable further use and continue to establish the value of RWE in regulatory processes

More information on the workshop, which will be broadcast live, can be found here.

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