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How to master both Marketing Authorization and Joint Clinical Assessment successfully?
Published on: Oct 18th, 2024
The European Union is transforming its health technology assessment process with the introduction of the Joint Clinical Assessment (JCA) under the new HTA Regulation. This major change aims to streamline clinical evaluations across member states, harmonizing the process and improving market access for innovative therapies.
The EU JCA will be mandatory for all new oncology products and advanced therapies (ATMPs) for which a Marketing Authorization Application (MAA) is submitted to the EMA from 12th January 2025.
In the webinar, we compared with the current framework, highlighted the shift, clarified roles and shared a case study.
Key learning points:
- To Gain a firm understanding of the JCA process and how it fits in with the Marketing Authorization process.
- To Provide an understanding of how the JCA will impact the execution and timing of pre-launch activities and local reimbursement processes. What is new and what is still the same.
- To prepare you for the JCA, allow you to optimize your resources and be prepared.
SAMPLE OF THE WEBINAR
How to master both Marketing Authorization and Joint Clinical Assessment successfully? (Teaser)
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