RegRapPod: InConversation

InConversation talks about conditional marketing authorisation − and how the work starts after approval – with Catherine MoncadConditional marketing authorisation (CMA) can help bring innovative medicines to patients with high unmet medical need sooner. But for sponsors, particularly emerging biotechs and first-time marketing authorisation holders, approval is only the beginning.In this latest episode of the RegRapPod − InConversation series, Regulatory Rapporteur Managing Editor Claire McDermott speaks with Catherine Moncad, Vice President of Regulatory Services at TMC Pharma Services Ltd, about the realities of planning for, securing and maintaining a conditional marketing authorisation in the EU.

In this episode of RegRapPod – InConversation, host Claire McDermott talks with TOPRA President Aman Khera about the ever-changing world of regulatory affairs and how TOPRA can support professionals navigate this complex landscape.

In this episode of RegRapPod – InConversation, co-hosts Claire McDermott and Ming Ewe sit down with Magda Papadaki, CEO of CoreTech Sciences and Venture Adviser, to explore how regulatory professionals can unlock new, entrepreneurial career opportunities.

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.

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.