All articles by Claire McDermott
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PodcastsRegRapPod − InConversation with Aman Khera
InConversation talks about opportunities and disruptors within the regulatory affairs industry with Aman Khera
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PodcastsRegRapPod − InConversation with Magda Papadaki
InConversation talks portfolio careers with Magda Papadaki and Ming Ewe
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Industry newsMHRA seeks views on indefinite acceptance of CE-marked medical devices
This industry news update summarises the MHRA proposals for indefinite recognition of CE-marked medical devices in Great Britain and the potential impact for health systems and patients.
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Industry newsNew ICH M15 Guideline sets harmonised framework for MIDD
This industry news update gives details of the ICH M15 adoption and its aim to establish standardised good practice for the use of evidence derived from model-informed drug development.
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Industry newsFDA approves non-invasive device for pancreatic cancer treatment
This industry news update shares details of the FDA’s approval of Optune Pax, a medical device enabling treatment in a home setting.
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PodcastsRegRapPod − InConversation with Parexel
InConversation talks Joint Clinical Assessment with Sangeeta Budhia and Sinan Sarac
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Journal2025 UK MDR Regulatory Conference: Meeting report
This article is a report of the 2025 UK MDR Regulatory Conference that was hosted by TOPRA and RAPS.
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Journal2025 Regulatory Intelligence Conference Europe: Meeting report
This article summarises sessions from the TOPRA/RAPS 2025 Regulatory Intelligence Conference Europe.
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InterviewLeveraging regulatory science expertise for next-generation technologies
The Orchard Therapeutics’ OTL-200 Regulatory Team, UK, was the winner of the ‘Futures’ award at the 2024 TOPRA Awards for Regulatory Excellence. In this interview, David Uguen, Senior Vice President and Head of Regulatory, shares learnings from the team’s journey from development to registration of the OTL-200 gene therapy.
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Industry newsRegulatory Rapporteur is back in PDF format
News of an exciting new development for Regulatory Rapporteur starting in October 2025.
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InterviewHow to advance your career and grow with the industry
This interview is with Monica Pianella who was a finalist at the 2024 TOPRA Awards for Regulatory Excellence. In this interview, Monica discusses what has inspired her and the skills needed when starting out in a regulatory affairs career.
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Industry newsSurvey shapes Regulatory Rapporteur’s future plans
An update on how readers’ feedback is informing future developments for Regulatory Rapporteur.
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PodcastsRegRapPod − InConversation with Zohra Nasir and Aksa Rahman
InConversation talks careers with Zohra Nasir and Aksa Rahman
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InterviewGlobal health equity: Inspiring collaboration and harmonisation
Rui Santos Ivo was awarded the prestigious ‘Lifetime Achievement’ Award at the 2024 TOPRA Awards for Regulatory Excellence. In this interview, he discusses his career journey and his thoughts on agencies’ challenges in ensuring global health equity.
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InterviewThe importance and evolving role of regulatory affairs education
Thuy Mason, MPharm Course Director and Senior Lecturer on the BSc Pharmaceutical Science with Regulatory Affairs and the MSc Pharmaceutical Science courses at Kingston University, was a finalist for the ‘Education’ award at the 2024 TOPRA Awards for Regulatory Excellence. In this interview, she discusses the evolution of the courses ...
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InterviewFAMHP: The role of the Belgian Agency in advancing public health
This interview with Professor Hugues Malonne, Chief Executive Officer of the Belgian Federal Agency for Medicines and Health Products (FAMHP) discusses the Agency’s role in helping shape regulatory affairs and improving health.
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InterviewCommunicating with regulatory affairs professionals: The power of the podcast
Harriet Edwards, finalist in the ‘Communication’ award category at the 2024 TOPRA Awards for Regulatory Excellence, talks about Boyds’ podcasts and their benefits as a way of consuming key regulatory information.
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InterviewHow to develop your skills and stand out from the crowd
Michelle Blake, Associate Director and Senior Regulatory Consultant at DLRC Ltd, and winner of the ‘Contribution’ award at the 2024 TOPRA Awards for Regulatory Excellence, discusses her career path in regulatory affairs and gives advice on how to develop your skills.
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InterviewHow to inspire a new generation of regulatory professionals
Kate Betteridge, Global Regulatory Portfolio Lead at Pfizer, and winner of the ‘Inspiration’ award at the 2024 TOPRA Awards for Regulatory Excellence, discusses strategies for harnessing innovation and creativity and her role in developing the regulatory professionals of the future.