All Journal articles – Page 3
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JournalThe evolving role of the regulatory professional in the age of Artificial Intelligence
This article explores how artificial intelligence can be used across dossier preparation, CMC, clinical development and more.
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JournalEmpowering digital innovation in CMC: A framework for regulatory readiness and confidence
This article looks at the evolution of CMC and technologies, such as AI, to help with applications, regulatory assessments and more.
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JournalRegulatory challenges and key considerations in the development of radiopharmaceuticals
This article looks at CMC, clinical and non-clinical considerations in the development of radiopharmaceuticals.
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JournalOverview of the regulatory and development landscape for brain-computer interfaces in neurodegenerative disease treatment
This article explores brain-computer interfaces (BCIs) for neurodegenerative disease treatments.
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JournalMedical device standards update: December 2025
This article is a continuation of previous updates that share medical device standards up to November 2025.
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JournalBringing innovation to market: Regulatory strategy for MedTech companies
This article explores the ever-changing MedTech landscape and the regulatory strategies to help companies navigate this.
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JournalA year of change for the US FDA: An update on notable pilots and programmes
This article updates on the FDA’s pilots and programmes that have been launched and also ongoing projects in 2025.
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JournalCross-functional strategies in clinical data disclosure for EMA Policy 0070 and Health Canada PRCI
This article discusses the requirements of clinical data transparency particularly in relation to the EMA Policy 0070 and HC PRCI.
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JournalFrom laboratory to patient: The role of New Substance Notifications in delivering innovative therapies in Canada
This article explores the new substance notification (NSN) processes and provides guidance on navigating this.
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JournalBridging the digital divide: A toolkit for equity-centred regulation of digital mental health
This article offers an overview of a proposed toolkit to support regulators and developers in embedding equity into digital mental health technology workflows.
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Journal2025 Regulatory Intelligence Conference Europe: Meeting report
This article summarises sessions from the TOPRA/RAPS 2025 Regulatory Intelligence Conference Europe.
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JournalVM6: Transitioning to animal-free chemical safety testing for veterinary medicines
This is a report of the VM6 session that took place at this year’s Symposium.
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JournalVM5: Regulatory considerations for novel veterinary therapies – Antimicrobials, immunologicals and biologicals
This is a report of the VM5 session that took place at this year’s Symposium.
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JournalVM4: The latest EU and international developments in Good Manufacturing Practice
This is a report of the VM4 session that took place at this year’s Symposium.
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JournalVM1: Meeting the objectives of the Veterinary Regulation
This is a report of the WM1 session that took place at this year’s Symposium.
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JournalVM2: Regulatory updates
This is a report of the VM2 session that took place at this year’s Symposium.
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JournalVM3: Regulatory updates in veterinary pharmacovigilance – Navigating evolving challenges
This is a report of the VM3 session that took place at this year’s Symposium.
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JournalIVD8: The hunt for evidence – An IVD perspective
This is a report of the IVD8 session that took place at this year’s Symposium.
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JournalIVD7: EU reference laboratories under the IVDR – One year on
This is a report of the IVD7 session that took place at this year’s Symposium.
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JournalIVD5: Navigating conformity assessment for IVDs – Challenges and opportunities
This is a report of the HM5/MD1/IVD1 session that took place at this year’s Symposium.