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

How to build a portfolio career using your regulatory expertise

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.

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.

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.

FAMHP: The role of the Belgian Agency in advancing public health

In this episode of RegRapPod – InConversation, host Claire McDermott and members of TOPRA’s Benelux Steering Group talk with Hugues Malonne, Chief Executive Officer of Belgium’s Federal Agency for Medicines and Health Products (FAMHP) about the Agency’s strategic priorities, its role in shaping and facilitating European legislation and how it collaborates with other regulators, both within and outside the EU.

InConversation with Ivo Claassen - Veterinary Regulation 2019/6: Impact, challenges and the future

InConversation talks veterinary regulation with Ivo Claassen In this episode of RegRapPod - InConversation, host Claire McDermott talks with Ivo Claassen, Head of the Veterinary Medicines Division and Deputy Executive Director of the European Medicines Agency (EMA) about Veterinary Regulation 2019/6. This legislation represents a fundamental overhaul of the regulatory system for veterinary medicines, and this pod discusses its aims, its implementation challenges, its impact and what the future holds for the veterinary regulatory profession.