This interactive workshop brings together leaders across epidemiology, biostatistics, HEOR, and market access to examine where RWE breaks down in practice, and how to design evidence that consistently delivers decision impact.

This workshop will gather experts to discuss:

• Identifying where RWE fails to translate into regulatory, payer, and clinical decisions despite strong methodology
• Understanding how different stakeholders interpret uncertainty, bias and evidence strength, and why alignment breaks down even with high-quality data
• Balancing data complexity with clarity by ensuring analytical approaches, including advanced methods and AI, remaining interpretable and decision‑relevant
• Applying statistical and epidemiological rigor to improve comparability, mitigate bias, and ensure outputs are credible across use cases
• Designing evidence strategies earlier in development that align with downstream

decision needs to reduce rework, delays, and missed impact