InConversation talks Joint Clinical Assessment with Sangeeta Budhia and Sinan Sarac
In this episode of RegRapPod – InConversation, host Claire McDermott talks with Sangeeta Budhia, Senior Vice President and Global Head of Pricing, Market Access and Evidence Evaluation, and Sinan Sarac, Senior Vice President and Head of Oncology Europe, Regulatory Consulting, both at Parexel, about Joint Clinical Assessment (JCA) implementation in Europe.
Established under Regulation EU 2021/2282, with the aim of providing a standardised process for evaluating clinical evidence of health technologies, the JCA process is mandatory. It was implemented in January 2025 for oncology drugs and cell and gene therapies and extends to orphan drugs in 2028 and all products in 2030.
This podcast walks listeners through not only the basics of JCA, but also the key challenges in preparing submissions, how to navigate them, how to integrate your evidence generation strategy and how JCA will influence regulatory strategy and clinical development planning for future products.
Further resources discussed in this podcast:
- The EU’s Health Technology Assessment Regulation: Overview and considerations for regulatory teams
- HM7: First experiences with the HTA Regulation (TOPRA Symposium 2025)
- A key role for the European Medicines Agency in the European Union’s Health Technology Assessment Regulation
SHOW NOTES:
If you would like to advertise on the RegRapPod InConversation, please contact our Commercial team at commercial@topra.org. For any other queries you can write to Claire McDermott, Managing Editor, at publications@topra.org
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