Latest updates from EU: Develop Once, Access Europe: The Power of Joint Clinical Assessment (JCA)
At Parexel, we're committed to guiding you through the evolving European regulatory landscape. Join us as we delve into the Joint Clinical Assessment (JCA) process and its profound impact on market access strategies.
Key Topics:
- Introduction to JCA • Understand the fundamentals and implications of JCA • Learn how JCA is reshaping the European regulatory landscape
- HTA-proofing Development • Discover how JCA impacts early trial design • Strategies for aligning clinical development with HTA requirements
- Beyond Efficacy: Integrating Value into EMA Assessment • Learn techniques for incorporating value propositions into regulatory submissions • Understand how to balance efficacy data with value demonstrations
- Bridging the Gap to HTA Acceptance • Explore strategies to align regulatory approvals with HTA expectations • Learn how JCA can streamline the path from EMA approval to HTA acceptance
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