EMA releases Youtube Videos of Workshop on Real World Data

The European Medicines Agency (EMA) held a workshop in June on the quality of Real World Data (RWD) and its use to demonstrate Real World Evidence (RWE). In the meantime, video recordings of both days have been published.

The "Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE)" was a hybrid meeting held on June 26-27, 2023. The recordings of the two days of the workshop have now been published on the workshop website as Youtube videos.

During the workshop, experiences with submissions in regulatory processes and lessons learned from previous projects around data standardization, metadata, data quality and DARWIN EU® were reported. In addition, the workshop covered the following topics:

• Challenges related to measuring and characterizing data quality in the context of RWE generation.
• Approaches and considerations for Real-World Data in the context of EU data quality requirements.
• Current experiences and lessons learned from the use of RWE in a regulatory context.
• Experiences of the European Medicines Regulatory Network (EMRN) from the COVID-19 pandemic and reflections on how RWE can be used to manage public health emergencies.
• Exchange of views among stakeholders on how to potentially expand the use of RWE in regulatory processes.

As previously reported, a document entitled "Real-world evidence framework to support EU regulatory decision-making" was published to accompany the workshop, describing lessons learned from agency-led studies between September 2021 and February 2023.