Unlock the Path to Successful EU JCA Submissions

The European Union’s Joint Clinical Assessment (JCA) is reshaping the landscape for health technology assessments, providing a streamlined process for evaluating clinical effectiveness across all EU Member States. This comprehensive eBook is your ultimate guide to navigating the complexities of the EU JCA framework, empowering pharmaceutical companies and technology developers to optimize their market access strategies.

Key Topics

• Understanding the EU Commission Implementing Act
  Learn about the procedural and methodological details outlined in the final Implementing Act, including the expanded evidence requirements and its impact on regulatory submissions.
• Strategic Planning for EU JCA
  Discover a step-by-step roadmap for aligning clinical, regulatory, and market access teams, ensuring evidence generation and submissions are fully optimized for JCA timelines.
• Interdependencies Between EU JCA and Local HTAs
  Explore the balance between EU-level assessments and local health technology evaluations in key markets like Germany and France, and learn how to effectively prepare for overlapping requirements.
• Overcoming Challenges in Market Access
  Address uncertainties in the JCA process, from managing multiple PICO requests to adapting global evidence for local submissions, while leveraging real-world data for comprehensive evaluations.