Join Cytel for a 2 part webinar series covering EU Joint Clinical Assessment (JCA) and Health Technology Assessment (HTA). 

Webinar 1: Anticipating the Unknowns of the EU HTA Regulation; Setting Timelines for Optimal EU JCA Preparation

As the European HTA Regulation is coming into effect on 1st January 2025, Cytel experts will guide sponsors on the timeline of preparatory activities leading to their first EU HTA submissions. Our experts will outline a comprehensive roadmap covering global value dossiers, regulatory submissions, EU JCA and local HTA submissions, ensuring streamlined efficiencies across overlapping activities. The speakers will also address aspects of the EU JCA that are currently “unknown”, as well as potential drawbacks that could impact market access routes, providing valuable insights for sponsors. 

The first webinar will cover :

•    Overview of timelines for EU JCA submissions and expected overlap with EMA submissions.
•    Timeline plan for preparatory activities, optimizing coordination among tasks such as global value dossier creation, evidence generation and synthesis activities to enhance efficiency.
•    Mapping predictable interdependencies in the preparation of EU JCA and local HTA submissions, while also strategizing for uncertainties in the implementation process.

Webinar 2: From EU JCA to Local HTA Submissions: Understanding Commonalities, Differences, and Gaps in Methodological Guidance Across Key EU Markets

Building on webinar one with the aim to ensure a seamless transition in preparatory activities from EU JCA to local HTA submissions, Cytel experts will provide an overview of published EU methodological guidance documents and provide a critical assessment of their commonalities, differences and gaps across EU JCA and key EU markets. 

The second webinar will cover:

•    Mapping of available methodological guidance and templates across EU HTAR and select local HTA bodies 

•    Assessment of commonalities, differences, and gaps in guidance for evidence submission and assessment requirements for EU JCA and local HTA dossier submissions

For more information about the series or reporting registration issues, please contact Nathan.trott@cytel.com.

To learn more on the topic read our EU JCA Blog here