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ViewAttendees 4

Pharmaceuticals

Real-World Evidence

Thursday, May 7, 2026
10:45 - 11:45 WEST
Location: Auditorium 3
Description This panel discussion explores the rapidly evolving landscape of Real-World Evidence (RWE) and its integration into the European regulatory framework. As the European Medicines Agency (EMA) and national competent authorities move toward more data-driven decision-making through initiatives like DARWIN EU, this session examines how RWE can complement traditional clinical trial data and be used in regulatory data package.

Panelists will discuss the challenges of data quality, the harmonization of electronic health records (EHRs) across borders, and the practical application of RWE in supporting post-market surveillance and label expansions.

Learning Objectives:

  • aluate the current regulatory requirements and expectations for submitting RWE in support of pharmaceutical and medical device applications in the EU.
  • Identify key technical and ethical hurdles in collecting real-world data, including data privacy (GDPR) and interoperability.
  • Implement strategies to integrate RWE into the product lifecycle to enhance post-market safety monitoring and demonstrate clinical value.