All Regulatory Rapporteur articles in September 2025
View all stories from this issue.
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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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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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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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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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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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ContentsSeptember 2025 – Contents
The September issue of Regulatory Rapporteur focuses on product information.
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EditorialReimagining product information
This issue delves into the fundamental role of product information and the processes for its management, and explores how technological advancements are shaping its evolution, with patients’ needs at its core.
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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.