RegRapPod: InConversation
RegRapPod: InConversation
Podcast Description
RegRapPod: InConversation is the podcast series of the TOPRA member's journal Regulatory Rapporteur. If you'd like to appear as a guest on the podcast, or otherwise contribute to the journal, please email [email protected].
Podcast Insights
Content Themes
The podcast explores themes surrounding regulatory affairs in the pharmaceutical industry, with episodes focusing on electronic product information (ePI), sustainability in pharmaceuticals, career paths into regulatory roles, and the challenges posed by Identification of Medicinal Products (IDMP) requirements.
RegRapPod: InConversation is the podcast series of the TOPRA member’s journal Regulatory Rapporteur.
If you’d like to appear as a guest on the podcast, or otherwise contribute to the journal, please email [email protected].
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.
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