A Human Touch: Real-World Patient Data in Regulatory Submissions and Beyond

The growing emphasis on real-world evidence (RWE) in regulatory submissions is transforming the landscape of drug development, with patient-centric data playing an increasingly crucial role.

This session provides an in-depth look at how RWE is shaping regulatory processes and patient care. Led by industry experts Michael Forstner, Senior VP of Pharmacoepidemiology and Risk Management, and Maartje Smulders, Senior Director of Pharmacoepidemiology, this session will explore the current EMA and FDA ambitions for RWE integration, present real-world case studies, and discuss the future potential of holistic, patient-centered RWE approaches.