Shows
RegRapPod: InConversationHow to build a portfolio career using your regulatory expertiseIn 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.
2026-04-0836 minRegRapPod: InConversationJoint Clinical Assessment: How to align your regulatory and access strategiesIn 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.Th...
2026-01-2833 minRegRapPod: InConversationCareers: Landing your first role in regulatory affairsIn 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 hi...
2025-08-1333 minRegRapPod: InConversationFAMHP: The role of the Belgian Agency in advancing public healthIn 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.
2025-06-1833 minRegRapPod: InConversationInConversation with Ivo Claassen - Veterinary Regulation 2019/6: Impact, challenges and the futureInConversation 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.
2025-04-0727 minRegRapPod: InConversationInConversation with the UK ePI Task Force - The path to a digital futureIn 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.
2025-02-0415 min
RegRapPodJune 2024 - Access to MedicinesIn this episode of RegRapPod, host Alan Booth hears from Issue Editor Davina Stevenson about the contents of the latest issue of Regulatory Rapporteur which focuses on access to medicines. Davina Stevenson is Executive Director of Inspection Management and Intelligence Implementation for R&D quality at Gilead Sciences Int Ltd., UK. ----------------------------------------------------------------SHOW NOTES:Alan Booth presented this podcast and the producer was JohnZeus Pauig. If you would like to advertise on RegRapPod, please contact Erik Smit at Erik@topra.org For any other queries, please contact publications at publica...
2024-06-2713 minRegRapPod: InConversationInConversation with Bengt Mattson - SustainabilityBONUS 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:
2024-05-3130 minRegRapPodInConversation with Bengt Mattson - SustainabilityBONUS 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:
2024-05-3130 minRegRapPodMay 2024 - ATMPsIn this episode of RegRapPod, host Alan Booth hears from Issue Editor, and Regulatory Rapporter Editorial Board member, Harriet Edwards, to discuss the focus topic of this issue which is ATMPs. Harriet Edwards is Associate Director, Regulatory Affairs, Boyd Consultants Ltd., UK ----------------------------------------------------------------SHOW NOTES:Managing Editor of Regulatory Rapporteur Alan Booth presented this podcast and the producer was Daisy Edwards (for the very last time); both at TOPRA in London.If you would like to advertise on the RegRapPod, please con...
2024-05-1015 minRegRapPodInConversation with Helena Corte-Real - CareersBONUS 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 podcas...
2024-04-2626 minRegRapPod: InConversationInConversation with Helena Corte-Real - CareersBONUS 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 podcas...
2024-04-2626 minRegRapPodApril 2024 - DataIn this episode of RegRapPod, host Alan Booth hears from Issue Editor, and Regulatory Rapporter Editorial Board member, James McCormick, to discuss the focus topic of this issue which is all things data. James McCormick is Senior Director, Regulatory Affairs, PPD Global Ltd, UK ----------------------------------------------------------------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 E...
2024-04-1213 minRegRapPodMarch 2024 - Asia-PacificIn this episode of RegRapPod, host Alan Booth hears from Issue Editors, and Regulatory Rapporter Editorial Board members, Vickie Goff and Harriet Edwards, to discuss the focus topic of this issue, the Asia-Pacific region.Vickie Goff is Head of Marketed Products and Regulatory, CMC, Mundipharma, UKHarriet Edwards is Associate Director, Regulatory Affairs, Boyd Consultants Ltd., UK----------------------------------------------------------------SHOW NOTES:Managing Editor of Regulatory Rapporteur Alan Booth presented this podcast and the producer was Daisy Edwards; both at TOPRA in London.
2024-03-2612 minRegRapPodFebruary 2024 - MedtechIn this episode of RegRapPod, host Alan Booth hears from Issue Editors, and Regulatory Rapporter Editorial Board members, Dejan Brkic and Esteban Herrero-Martinez to discuss the medical technologies focus topic of this issue.Dejan Brkic is Senior Director Regulatory Affairs, Head of Regulatory Development Solutions at PPD, part of Thermo Fisher Scientific, in Cambridge.Esteban Herrero-Martinez is Director of Regulatory Policy and Intelligence at AbbVie, in Slough.----------------------------------------------------------------SHOW NOTES:Managing Editor of Regulatory Rapporteur Alan Booth presented this podcast and the...
2024-02-2015 minRegRapPodInConversation with TOPRA’s RegOps SPINBONUS EPISODE: In Conversation with TOPRA's RegOps SPINIn 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 scienceVigneshram Rengarajan, Manager, R&D Business Consulting at BASE life scienceElisabetta Rossi, Regulatory Affairs Senior Director...
2024-02-0233 minRegRapPod: InConversationInConversation with TOPRA’s RegOps SPINBONUS EPISODE: In Conversation with TOPRA's RegOps SPINIn 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 scienceVigneshram Rengarajan, Manager, R&D Business Consulting at BASE life scienceElisabetta Rossi, Regulatory Affairs Senior Director...
2024-02-0233 minRegRapPodJanuary 2024 - BiologicsJANUARY 2024In this episode of RegRapPod, host Alan Booth hears from Issue Editors, and Regulatory Rapporter Editorial Board members, Ash Ramzan and Julie Warner to discuss their Biologics issue of the journal.Ash Ramzan is Principal Consultant at Woodley BioReg, in Huddersfield, West Yorkshire.Julie Warner is Vice President, Regulatory Affairs at Boyds Consultants in the UKSHOW NOTES:Managing Editor of Regulatory Rapporteur Alan Booth presented this podcast and the producer was Daisy Edwards; both at TOPRA in London.
2024-01-1518 minRegRapPodNovember 2023 - North AmericaNovember 2023In this episode of RegRapPod, host Alan Booth hears from Issue Editor, and Regulatory Rapporter Editorial Board member, Leah Kleylein on her North America edition of the journal.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 Erik@topra.org For any other queries, please contact Daisy at daisy@topra.org, or write to the...
2023-12-1315 minRegRapPodOctober 2023 - Veterinary medicineOctober 2023In this episode of RegRapPod, host Alan Booth hears from Issue Editor, and Regulatory Rapporter Editorial Board member , Kornelia Grein about the veterinary medicines focus articles.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 Erik@topra.org For any other queries, please contact Daisy at daisy@topra...
2023-12-1214 minRegRapPodSeptember 2023 - Globalisation and the supply chainSeptember 2023In this episode of RegRapPod, host Alan Booth hears from Issue Editor, and Regulatory Rapporter Editorial Board member and Deputy Editor, Vickie Goff about globalisation and the supply chain.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 Erik@topra.org For any other queries, please contact Daisy ...
2023-09-1514 minRegRapPodJuly/August 2023 - Equal Access to MedicinesJuly/August 2023In this episode of RegRapPod, host Alan Booth hears from Issue Editor Ash Ramzan about equal access to medicines.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 Erik@topra.org For any other queries, please contact Daisy at daisy@topra.org, or write to the Editor at...
2023-08-1618 minRegRapPodJune 2023 - Clinical TrialsJune 2023In this episode of the RegRapPod, June's Issue Editor, Sarah Roberts, discusses the main focus topic of Clinical Trials with the journal's Managing Editor, Alan Booth.SHOW NOTES:This podcast was presented by Alan Booth and the Producer was Daisy Edwards at TOPRA in London. If you would like to advertise on the RegRapPod, please contact Erik Smit at Erik@topra.orgFor any other queries, please contact Daisy at daisy@topra.org, or write to the ...
2023-06-1534 minRegRapPodMay 2023 - ATMPsMay 2023In this episode of the RegRapPod, May's Issue Editor, Harriet Edwards, discusses the main focus topic of AMTPs with the journal's Managing Editor, Alan Booth.SHOW NOTES:This podcast's Presenter was Alan Booth and the Producer was Daisy Edwards at TOPRA in London. If you would like to advertise on the RegRapPod, please contact Erik Smit at Erik@topra.orgFor any other queries, please contact Daisy at daisy@topra.org, or write to the Editor ...
2023-05-1520 minRegRapPodApril 2023 - Latin AmericaApril 2023In this episode of the RegRapPod, April's Issue Editor, Vickie Goff, discusses the main focus topic of Latin America with the journal's Managing Editor, Alan Booth.SHOW NOTES:This podcast's Presenter was Alan Booth and the Producer was Daisy Edwards at TOPRA in London. If you would like to advertise on the RegRapPod, please contact Erik Smit at Erik@topra.orgFor any other queries, please contact Daisy at daisy@topra.org, or write to the Editor
2023-04-1519 min