ISPOR Europe 2026
Talk Real-World Evidence (RWE) track
Spotlight on Joint Clinical Assessments: Learnings to Date, Looking Ahead at Rare Indications, and AI Applications to Enhance Evidence Generation
Mon, Nov 9, 2026 · 12:45–1:15 PM CET Theater 1, Hall X1-X4, Level -2, Austria Center Vienna
About this session
The European Union Joint Clinical Assessment (JCA) will become mandatory for orphan-designated medicinal products in 2028, introducing new expectations for comparative, patient-relevant evidence. Orphan drug developers face unique challenges, including small patient populations, heterogeneous disease presentation, varying standards of care across Member States, and limited availability of comparative clinical data.
Speaker
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PAREXEL
Speaker