All Artificial intelligence (AI) articles
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JournalSandbox of trust: Regulated AI for health promotion and disease prevention
This article explores the capacity and potential for AI tools in analysing health data and helping with disease prevention.
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ContentsJune 2025 – Contents
The June issue of Regulatory Rapporteur focuses on veterinary medicines.
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EditorialVeterinary medicines: Translating regulation into practice
This issue looks at the impact of the Veterinary Regulation 2019/6, the effect of the new EMA fees on marketing authorisation holders, and the regulatory challenges associated with the practical use of bacteriophages in veterinary medicine.
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JournalArtificial intelligence and post-market surveillance
Artificial intelligence (AI) is a force that is both feared and revered for promising revolutionary improvements in many fields. While tools like ChatGPT may create an impression of AI being easy to use, such wide AI applications are prone to hallucinations, or misleading information, and therefore can be dangerous in the context of post-market surveillance (PMS). The more accurate narrow AI tools for PMS do not yet exist, but hold a lot of promise for the future. The solution for effective PMS by AI will require restructuring data into appropriate formats for machine learning (ML).
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JournalAI adoption readiness: Current status and trends in regulatory organisations
There is no doubt that artificial intelligence (AI) and other advanced technologies (AT) will add significant value to global regulatory practices over time. However, it is still unclear how and when integration to a trusted level with attractive business benefits will be achieved for most organisations.
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JournalImplications of the EU’s AI Act for medical devices and in vitro diagnostic medical devices
The integration of artificial intelligence within healthcare has heralded a new era of innovation for medical devices and in vitro diagnostics. This article explores some implications of the EU’s AI Act for the existing regulatory frameworks governing MDs, specifically the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
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Industry newsFDA releases new draft guidance on assessing artificial intelligence data
The US Food and Drug Administration (FDA) has released new draft guidance which provides a risk-based credibility framework that can be used for assessing artificial intelligence (AI) data in the drug product lifecycle.
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JournalThe role of artificial intelligence in regulatory affairs
This article explores the enormous potential of artificial intelligence (AI) technologies in regulatory affairs, highlighting how AI can streamline regulatory compliance, expedite submissions, enhance predictive analytics for decision-making, improve pharmacovigilance and elevate regulatory intelligence when properly applied. The discussion covers not only the advantages of AI but also the complexities of integrating AI into regulatory affairs, such as the challenges of algorithm interpretability, data quality, regulatory compliance, fairness, security, privacy and model accuracy. Additionally, it emphasises the collaborative efforts of the global regulatory community in developing guidelines and frameworks for the safe and effective use of AI.
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Industry newsRegulators publish new guidelines for use of AI
The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) publish new guiding principles for the use of large language models (LLMs) in regulatory affairs.
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Industry newsAI used to predict candidate antibiotics in radical study
AI machine learning algorithms have been used in a study to identify candidate compounds for investigation as potential new antibiotics.
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PodcastsRegRapPod − April 2024
Vol.21 #4: In April 2024’s RegRapPod, host Alan Booth talks to Issue Editor James McCormick about all things data.
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