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 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.

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.

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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-Real

In 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]

BONUS EPISODE: In Conversation with TOPRA's RegOps SPIN

In this episode of RegRapPod - In Conversation, host Alan Booth hears from industry experts about the Identification of Medicinal Products (IDMP) requirements and how organisations are navigating the challenges it is posing for industry and the opportunities they also bring. Joining Alan on the podcast are:

• Ramón Hernández Moratinos, Senior Consultant, R&D Business Consulting at BASE life science
• Vigneshram Rengarajan, Manager, R&D Business Consulting at BASE life science
• Elisabetta Rossi, Regulatory Affairs Senior Director - Primary & Specialty Care and Global Operations, Dompé farmaceutici S.p.A.
• Daniele Severa, Digital Regulatory Affairs Senior Specialist, Dompé farmaceutici S.p.A.

SHOW NOTES:
Managing Editor of Regulatory Rapporteur 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 contact Daisy at [email protected], or you can write to Alan Booth, managing editor, at [email protected]