Conditional marketing authorisation in the EU: Manging the path from approval to full licence

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.

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 talks veterinary regulation with Ivo ClaassenIn 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.

In this episode of RegRapPod - InConversation, host Claire McDermott hears from Andrew Burgess of Sanofi and Michael Clarke of the British Generic Manufacturers Association who are both members of the UK ePI Task Force. This Pod explores electronic product information (ePI) for medicinal products and asks why it's important, what the implementation challenges are for industry and how the Task Force is moving ePI forward.

BONUS EPISODE: In Conversation talking careers with Bengt Mattson   In this episode of RegRapPod - In Conversation, host Alan Booth hears from Bengt Mattson who is Policy Manager at LIF, which is the trade association for the research-based pharmaceutical industry in Sweden. Bengt previously gave the Welcome Lecture to launch the TOPRA Symposium 2023. Here the pod caught up with Bengt for a wide-ranging discussion on sustainability and how environmental legislation in the EU will likely effect the pharmaceutical sector.---------------------SHOW NOTES:Alan Booth presented this podcast and the Producer was Daisy Edwards both at TOPRA in London. If you would like to advertise on the RegRapPod, please contact Erik Smit at [email protected] For any other queries, please write to Alan Booth, Managing Editor, at [email protected]  

BONUS EPISODE: In Conversation with Helena Corte-RealIn this episode of RegRapPod - In Conversation, host Alan Booth hears from Helena Corte-Real who is Vice President, Regulatory Portfolio Data and Content Lead with Roche in Basel, Switzerland. Helena has previously been a speaker at TOPRA’s Regulatory Careers Live events and the pod caught up with her to hear about her career path into regulatory via a PhD in marine biology and medical writing.SHOW NOTES:Alan Booth presented this podcast and the Producer was Daisy Edwards both at TOPRA in London. If you would like to advertise on the RegRapPod, please contact Erik Smit at [email protected] For any other queries, please write to Alan Booth, Managing Editor, at [email protected]