All AI articles
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JournalUsing data to drive regulatory performance
Life sciences companies, whether they are pharma, biotech, MedTech or diagnostic, all aim to get products to patients as quickly and efficiently as possible. To do so, they rely on knowledge of their regulatory ecosystem (henceforth referred to as regulatory intelligence).
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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Industry newsFDA releases new draft guidance on assessing artificial intelligence data
The US Food and Drug Administration (FDA) has released new draft guidance which provides a risk-based credibility framework that can be used for assessing artificial intelligence (AI) data in the drug product lifecycle.
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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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PodcastsRegRapPod − February 2024
Vol.21 #2: In February 2024’s RegRapPod, host Alan Booth talks to Issue Editors Dejan Brkic and Esteban Herrero-Martinez about medtech.
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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
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Podcasts
RegRapPod − January 2024
Vol.21 #1: In January 2024’s RegRapPod, host Alan Booth talks to Issue Editors Julie Warner and Ash Ramzan about biologics.
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JournalArtificial intelligence in drug discovery
Regulatory Rapporteur January 2024 | Volume 21 | No.1 Introduction The recent publication of papers by the European Medicines Agency (EMA)[1] and the Food and Drug Administration (FDA)[2][3] has spurred the debate on ...
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FocusTranslating digitalisation trends into tangible solutions
Pharmaceutical companies are seeking to take advantage of digital innovations to become data-driven organisations, but rstly, they must overcome various data challenges to move from concept to execution. Timm Pauli, Head of R&D Informatics at PharmaLex, and Dr. Torsten Osthus, Advisory Consultant to PharmaLex and Managing Director of Osthus Group, (whose service division, Osthus Services, recently merged with PharmaLex), explore the path to successful R&D digitalisation.