All Artificial intelligence articles
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JournalEmergency use authorisation of in vitro diagnostic devices by the US FDA: The regulatory framework, lessons from COVID-19 and future directions
This article explores the FDA’s Emergency Use Authorisation framework and its aim to speed up the deployment of IVDs during public health emergencies, focusing on its evolution, operational mechanisms and significance in public health preparedness.
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JournalThe strategic role of Regulatory Operations in digital transformation success
This article discusses how Regulatory Operations is evolving from document-centric gatekeeper to data-driven strategic partner, and uses a case study from Syneos Health to show how its RegOps team led an initiative to deploy GenAI tools for patient narratives, CMC extraction and plain language summaries
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JournalTOPRA Annual Lecture 2026: The Global Imperative for Responsible AI in Healthcare
This article summarises the discussions at TOPRA’s Annual Lecture 2026, which focused on the responsible global govenance of AI in healthcare
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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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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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JournalPrescribing efficiency: Using generative artificial intelligence for pharmacovigilance
Pharmacovigilance stands as a cornerstone of patient safety but the processes can be arduous. This article explores how generative AI can optimise workflows, reduce reporting burdens and improve timeliness.
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CommentaryDeveloping a digital people strategy to harness the power of generative AI
Artificial intelligence is a science and applied technology that involves deductive processing and machine learning subsequently performing human-like tasks