Methodological Advances in Regulatory Real World Evidence Generation Systems: Perspectives from Sentinel and DARWIN-EU

Routinely collected longitudinal healthcare data including insurance claims and electronic health records (EHRs) remain the most important source for real world evidence (RWE) generation including studies of disease epidemiology, medical product utilization, and post-marketing safety. With availability of more granular infromation from variety of sources including EHRs, biobanks, and linked nation-wide registry data, the breadth of questions that can be reliably answered has increased.  

This presentation describes the expansion of data sources and resulting methodological innovations that improve national and international regulatory RWE generation systems. It was presented at the 2024 ISPE Annual Meeting.