Session (CTI)

As real-world evidence (RWE) becomes increasingly integral to regulatory, HTA, and payer decision-making in Europe, the ability to generate robust evidence from real-world data (RWD) across EU member states has emerged as a strategic priority. However, this remains challenging due to heterogeneity in healthcare data systems, variations in clinical coding, language and contextual differences, and uneven data infrastructure maturity. Recent reports from a consortium (Real4Reg) involving ten EU institutes, highlighted the constraints of availability and heterogeneity of RWD and the challenges in analyzing RWD from different settings and sources in the pre-authorization phase. Similarly, the TEHDAS report on Secondary Use of Health Data Through European Case Studies identified underdeveloped technical services and fragmented privacy regulations as significant barriers to cross-border RWD use (TEHDAS, 2022). To highlight these challenges and to discuss potential future solutions, this panel brings together industry experts with hands-on experience leading multi-country RWE initiatives across Europe. Panelists will share specific challenges they encountered including those related to data interoperability, multilingual unstructured data, and compliance with country-specific privacy frameworks and present viable, real-world solutions that enabled successful study execution. The discussion will cover data harmonization methodologies used to align heterogeneous clinical variables across countries, along with AI-enabled technologies such as natural language processing and machine learning to support multilingual data integration and automated data quality assessment, and the use of federated networks and synthetic data to enable privacy-preserving analytics. The panel will address challenges around data access, governance, and the complexities of navigating varying national data privacy policies, alongside operational frameworks that support consistent, transparent, and auditable study designs across jurisdictions.