Regulatory Rapporteur Interviews
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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 and go that extra mile.
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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.
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InterviewBengt Mattson reflects on sustainability
Bengt Mattson is Policy Manager at LiF, the trade association for the research-based pharmaceutical industry in Sweden. He is also the Co-chair of the three European pharmaceutical trade associations’ (AESGP, EFPIA and MfE) Task Force on pharmaceutical and environmental impacts. In this interview with Alan Booth, he reflects on sustainability in the regulatory environment.
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InterviewDr Peter Marks on reflecting innovation through FDA regulation
Harriet Edwards and Dr Katherine Bowen spoke to Dr Peter Marks, Director of Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA), about his career and the continued evolvement of regulation to support innovative medicines development
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JournalA harmonised approach to clinical data standards
David Evans, President and CEO of Clinical Data Interchange Standards Consortium (CDISC), speaks to the journal’s November Issue Editor Leah Kleylein to discuss his role at the helm of the standards development organisation and the ways it is advancing global data standards in the clinical research realm.
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InterviewPatients are at the centre of everything
Yaneth Giha, Executive President, FIFARMA, finds and implements solutions to enhance patient outcomes.
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InterviewEvery patient has a story to tell us
Dr Francesco Pignatti, Head of Oncology and Haematology at the EMA, discusses his career, his inspirations, and why it is important to involve patients in regulatory decisions.
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JournalDigital and data-driven: information management at the EMA
Dr Hilmar Hamann, Head of Information Management Division at the EMA, discusses key milestones in his career, the challenges faced and his long-term visions for information management legislation
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JournalUpdates to quality legislation from the EMA
Brian Dooley, Quality Specialist in the Pharmaceutical Quality Office of the EMA, discusses his role, new marketing applications and updates to quality legislation.
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JournalEvolutions in patient healthcare at MHRA
Chief Safety Officer, Alison Cave discusses her role at the MHRA, key objectives and ambitions for the regulator.
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JournalA review of paediatric development challenges, FDA collaboration and future trends
Susan McCune M.D. Susan McCune M.D., is a paediatrician and neonatologist, with 18 years’ academic clinical and research experience. This was followed by 18 years at the US FDA where, from 2017 to 2021, she was the director of the Office of Pediatric Therapeutics in the Office ...
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JournalThe national competent authorities of Belgium and Luxembourg share their views about the e-PIL Pilot
Q: Why do the authorities support the e-PIL Pilot and why do you think it is important? A: Iris Geussens: Digitalisation is the future, and the pharmaceutical sector cannot stay behind. The advantage of an electronic package leaflet is that you always have access ...
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FocusRegulating medicines in a surge of change
RegRap speaks to Steve Hoare, Quality Regulatory Science and Safety Policy Director at the ABPI
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InterviewA strong advocate for global harmonisation in animal health
Gavin Hall, Interim Director of Authorisations at the Veterinary Medicines Directorate, discusses the agency’s drive to harmonise scientific guidelines and its readiness to be flexible with regulatory frameworks following Brexit.
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InterviewBuilding best regulatory practices in Brazil
Gustavo Mendes Lima Santos, General Manager of Medicines and Biological Products at ANVISA, explains how the agency has aligned with best practices of others across the world, and discusses important updates to legislation in Brazil.
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