All Machine learning (ML) articles
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JournalHM6: How Artificial Intelligence is transforming regulatory approaches towards chemistry, manufacturing and controls (CMC)
This is a report of the HM6 session that took place at this year’s Symposium.
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Industry newsICH releases M15 guideline on model-informed drug development
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M15 Expert Working Group has developed a draft guideline on model-informed drug development (MIDD) and is now under public consultation.
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JournalAI meets medtech:
big opportunities
require a
measured approachRegulatory Rapporteur February 2024 | Volume 21 | No.2 Abstract Artificial intelligence (AI) and machine learning (ML)-enabled digital health technologies have great potential to improve patient care, strengthen diagnostic capabilities and enhance treatment options. Governments and healthcare professionals understand ...
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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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Industry newsSafe use of AI is subject of EMA reflection paper
The EMA has published a draft paper on how artificial intelligence can support the development and use of human and veterinary medicines.