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.
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Sample of the webinar
Featured Speakers
Decebal Bora, Pharm.D – MPH
Vice President Regulatory Strategy
Decebal is a highly experienced regulatory science professional with more than 25 years in the field of health products development in both pharma/biotech companies and consulting firms. His expertise lies in all regulatory activities on strategic and operational levels. He has been involved in pre-registration, launch and life cycle management activities in the field of drug development with interactions with the FDA, EMA, and national agencies. He is instrumental in strategizing and implementing the development of innovative and complex health products.
Gabrielle Nayroles, MSc
Director, Market Access
Gabrielle brings 25 years of experience from having worked in different business cultures in a variety of global market access positions in both pharmaceutical and biotech companies. She has hands-on experience in developing and leading pricing and reimbursement strategies. Her key achievements include the global launch of the oncology indication of Somatuline® and double-digit price increases in Europe.
Gabrielle has worked across a wide range of health technologies, including orphan drugs, advanced therapies, repurposed drugs. She has a broad therapeutic experience in Central Nervous System, Gastroenterology, Hematology, Endocrinology and Oncology.
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