REDDIE at joint Heads of Medicines Agencies/European Medicines Agency Big Data Steering Group Workshop on Real-World Evidence Methods

Last week, on Friday, 14 June 2024, the Joint Heads of Medicines Agencies/European Medicines Agency (EMA) Big Data Steering Group Workshop on Real-World Evidence (RWE) Methods took place in Amsterdam, the Netherlands.

The workshop brought together representatives from regulatory agencies, pharmaceutical companies, patient groups, healthcare professionals, academia, and health technology assessment bodies. Our coordinator, Julia Mader from the Medical University of Graz, attended the workshop in Amsterdam, where stakeholders discussed the integration of RWE methods in regulatory decision-making — a key focus for the REDDIE project.

The objectives of the workshop were to:

• Hear the views of stakeholders and experts:
  on the draft real-world evidence (RWE) reflection paper,
  on priorities for further regulatory guidance development and collaboration beyond the reflection paper.
  
• Engage with stakeholders on RWE methods in regulatory decision-making.

The workshop commenced with opening remarks from Emer Cooke, EMA Executive Director, and Jeppe Larsen, HMA BDSG Co-chair. The agenda featured presentations on the RWE Reflection paper, Target Trial Emulation in a regulatory context, and the use of RWD-derived external controls in a regulatory context. Each session was followed by panel discussions that included industry and patient representatives, academic researchers, regulatory authorities, and healthcare professionals.

The workshop marked an important step in discussing the use of real-world evidence in advancing healthcare. Participants shared valuable insights and identified key challenges, setting the stage for future improvements.

The outcomes of this workshop will influence future projects like REDDIE, driving innovation and ensuring that regulatory frameworks evolve to incorporate the latest advancements in real-world data methodologies. To continue this important work, we will organize our next stakeholder meeting in September. This meeting will again bring together patients, healthcare professionals, regulators, policymakers, and academia to discuss the best way to develop standards and guidance for better utilizing real-world data in diabetes regulation.

Learn more about the Big Data Steering Group Workshop: https://www.ema.europa.eu/en/events/joint-hma-ema-big-data-steering-group-workshop-real-world-evidence-rwe-methods#documents-66759