All Journal articles – Page 3
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JournalNavigating the landscape of paediatric clinical trials under US FDA guidelines
This article explores paediatric clinical trials under the guidelines of US Food and Drug Administration (FDA) legislation, focusing on research development and ethics.
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JournalMaximising regulatory success through early EMA engagement in drug development
This article explores the importance of early regulatory engagement with the EMA and some tools, guidance and procedures on offer.
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JournalCentral sourcing of authorised comparators and concomitant medications for multiregional clinical trials in accordance with ICH E17: CMC documentation requirements
This article uses the ICH E17 document to explore chemistry, manufacturing and controls requirements for inclusion in a clinical trial application.
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JournalDigital transformation of global regulatory affairs: Then, now and next
This article explores GenAI and Health Level 7’s (HL7) next generation standard for Fast Healthcare Interoperability Resources (FHIR).
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JournalTarget product profile and product profile characteristics for labelling during drug development
This article analyses the role of the TPP and PPC in labelling development and uses case studies as examples.
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JournalElectronic patient information: Results of the e-PIL pilot from Belgium and Luxembourg hospitals
This article discusses the 2018 e-PIL pilot in Belgium and Luxembourg including the paper and electronic versions of the patient information leaflet.
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Journal What could the future of labelling look like? The Gravitate-Health story
This article introduces the Gravitate-Health digital lens concept and talks about the value of ePI to help understand patient needs.
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JournalThe EMA/NCA electronic product information initiative: Engagement, implementation and vision for the future
This interview with Juan García Burgos discusses the upcoming EMA/National Competent Authority electronic product information (ePI) initiative.
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JournalProduct information: An overview
This article gives an introduction to product information, how it is created and managed, and the benefits of transitioning to electronic product information labelling.
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JournalTranslating real-world needs into digital medication tools: Good practices for co-creation with patients
This article discusses the importance of patient engagement in digital health tool development, using the case study of the Gravitate-Health project.
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JournalWhat is regulatory affairs, how does it fit into the bigger healthcare picture and the role of industry in the regulatory process
An overview of a session at Regulatory Careers Live 2025 for students, graduates and those hoping to enter the profession on the role of regulatory affairs in the healthcare industry
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JournalFDA comparability guidance: The impact of cell and gene therapy products
This article analyses FDA draft guidance and other guidance documents and aims to address concerns about CGT products.
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JournalDiversity in clinical research: Regulatory considerations and updates
This article explores how to improve diversity and patient representation in clinical trials and looks at guidance from the EMA.
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JournalThe importance of patient advocacy in the EMA ODD process
This article discusses the role of patient advocacy groups in the orphan drug designation process to incoporate more patient-centred approaches.
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JournalPatient involvement in the regulatory area: Insights into national level dialogues
This article explores the different areas of patient involvement in European NCA regulatory processes.
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JournalRealising opportunities to generate RWE for regulatory decisions through randomised pragmatic trials
This article summarises key features of the EFPIA paper and discusses how randomised pragmatic trials can be used to aid regulatory decision-making.
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JournalThe evolving landscape of public and patient involvement
This article explores public and patient involvement (PPI) and its impact in shaping national policies.
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JournalMedical device standards update: May 2025
This article updates the progress of applicable medical device standards to May 2025.
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JournalDivergence on the definition of regulatory reliance in international regions: Is there room for convergence?
The article explores how reliance pathways can be used for MAAs and incorporates AstraZeneca’s research findings on this topic.
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JournalVeterinary Regulation 2019/6: Impact, challenges and the future: Interview with Ivo Claassen
In this interview, Claire McDermott talks with Ivo Classen, Head of the Veterinary Medicines Division and Deputy Executive Director of the European Medicines Agency on the impact of Veterinary Regulation 2019/6.