All Regulatory Rapporteur articles in October 2026
View all stories from this issue.
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JournalLean writing and disclosure-ready principles for clinical trial design and documents
A disclosure-ready principle is most effective within clinical trial design from the start. This article offers a three-step lifecycle structure to embed disclosure readiness into an embedded authoring and review discipline and avoid downstream challenges.
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JournalThe evolving regulatory framework for clinical data management in the era of decentralised trials
This article examines the development of global regulatory expectations for clinical data management within decentralised clinical trials. It reviews strategies that CDM professionals are using and assesses current regulatory barriers and harmonisation gaps.
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JournalClinical trial diversity and regulatory decision-making: Implications for dosing, safety and global alignment
Through selected case studies, this article explores how evidence gaps related to sex, ethnicity and representative trial populations have shaped regulatory outcomes across different therapeutic areas and discusses strategies for more robust evidence generation.
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JournalMultistakeholder collaboration to translate the ICH GCP E6(R3) guideline into Finnish: Supporting clinical trial conduct in Finland
This article summarises the process and outcomes of the ICH GCP E6(R3) translation and terminology project, an example of multistakeholder collaboration to advance a shared understanding of a well-established international guideline in a national context
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JournalCOMBINE EU pilots: Roche’s experience as first pilot participants
Drawing on two successfully approved COMBINE pilot combined studies, this article shares practical experience of coordinated submissions and assessments, highlighting the benefits, operational challenges and potential solutions for making cross-regulation studies more efficient.
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JournalMoving towards one global paediatric development plan
This article reviews paediatric development requirements within a changing legislative landscape and proposes a model based on a single core scientific data package, supported by coordinated regional implementation.
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JournalThe compounding pharmaceutical data gap: The impact of structural under-representation on AI-augmented pharmacovigilance systems
This article traces the mechanism by which structural bias enters the product lifecycle and provides recommendations for marketing authorisation holders seeking to address inherited bias in deployed pharmacovigilance AI
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JournalICH Q6(R1): Harmonising specifications for chemical and biological products
This article provides an overview of the key concepts and anticipated impacts of the upcoming revision of ICH Q6(R1), highlighting how the integrated approach may reshape expectations for both traditional and innovative pharmaceutical products.
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EditorialClinical trial design and real-world evidence: What happens to the evidence next?
When does a clinical trial really end? This October issue of Regulatory Rapporteur explores the evidence continuum from clinical trial design to real-world use, examining diversity, decentralised trials, AI-enabled pharmacovigilance, regulatory convergence, disclosure and the global implementation of Good Clinical Practice. Together, these contributions consider how data are generated, managed and interpreted across the product lifecycle and what this means for evidence-based decision-making.
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ContentsRegulatory Rapporteur October 2026 – Contents
The October issue of Regulatory Rapporteur focuses on clinical trial design and real-world evidence.