From research to regulators: effectively using SDTM & OMOP

Real-world data (RWD) refers to health information collected outside of traditional clinical trials. Examples are electronic health records, disease-specific registries and insurance claims. In the regulatory context, RWD is increasingly being used to generate real-world evidence (RWE) that supports decision-making throughout the lifecycle of medical products.

In this webinar, we will explore the role of real-world data (RWD) in regulatory processes, with a particular focus on the OMOP Common Data Model (CDM). We will compare and contrast the OMOP CDM with the clinical trial data standard SDTM, highlighting key similarities and differences. Several European flagship projects will be presented to illustrate practical applications of these frameworks. The session will also address critical regulatory considerations, including data lineage, provenance, and validation requirements.

This session is for regulatory and compliance professionals, clinical data and research experts, data standards and informatics professionals.