『The First EU JCA Report: Methodological Learnings and Implications for Future Submissions』のカバーアート

The First EU JCA Report: Methodological Learnings and Implications for Future Submissions

The First EU JCA Report: Methodological Learnings and Implications for Future Submissions

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What can manufacturers learn from the first EU JCA report?

The first EU Joint Clinical Assessment report offers an early look at how evidence may be evaluated under the EU HTA Regulation. This episode explores key methodological learnings from the tovorafenib assessment and what they may mean for future submissions, especially in rare diseases.

Key Topics:
• PICO scope and consolidation
• Systematic literature review expectations
• Indirect treatment comparisons
• Single-arm evidence in orphan diseases
• Future JCA submission planning

Guests:
• Caroline Ling, Vice President, Health Outcomes – Europe
• Vijay D’Souza, Associate Director, European Value and Access

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