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RegRapPod: InConversation

Podcast af RegRapPod

engelsk

Videnskab & teknologi

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Læs mere RegRapPod: InConversation

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 claire.mcdermott@topra.org.

Alle episoder

9 episoder

episode Joint Clinical Assessment: How to align your regulatory and access strategies cover

Joint Clinical Assessment: How to align your regulatory and access strategies

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.

28. jan. 2026 - 33 min
episode Careers: Landing your first role in regulatory affairs cover

Careers: Landing your first role in regulatory affairs

In this episode of RegRapPod – InConversation, host Claire McDermott talks with Zohra Nasir, Senior Manager Regulatory Affairs at Teva Pharmaceutials, and Aksa Rahman, Regulatory Affairs Project Manager at Grunenthal Ltd, about careers in regulatory affairs and, in particular, how you find your first role. Aimed primarily at students, graduates and those who are considering a career in regulatory affairs, this podcast discusses how to identify roles that best suit you, how to gain experience and how to make your CV stand out from the crowd. It also discusses strategies that those in hiring positions in industry can adopt to help promote regulatory affairs as a career and how you can open doors for the next generation.

13. aug. 2025 - 33 min
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