All Regulatory Rapporteur articles in October 2025
View all stories from this issue.
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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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JournalProbiotics as nutraceuticals: Bridging science, health and regulation
This article explores the growth of probiotics globally and the various regulations and challenges to consider.
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JournalThe use of prior knowledge and platform approaches in early vaccine development
This article explores how platform approaches and prior knowledge can be used in the early development of vaccines.
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JournalICH Q1 guideline revisions to promote innovation and enable global patient access to high-quality medicines
This article looks at the new ICH Q1 stability guidance and its various approaches to help promote innovation.
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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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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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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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EditorialFrom trials to approval: Regulatory strategies in early drug development
This issue focuses on the acceleration of early drug development, the opportunities and challenges that this brings and strategic guidance for regulatory professionals.
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ContentsRegulatory Rapporteur October 2025 – Contents
The October issue of Regulatory Rapporteur focuses on early drug development.