The use of Artificial Intelligence technologies across medicines lifecycle has significantly increased in recent years and holds great promise as a tool to accelerate the path from innovation to safe and efficacious medicines. In this context, the European Medicine...
Two new reports highlight how Artificial Intelligence (AI) is reshaping healthcare and medicine development across Europe, offering major opportunities but also raising key challenges. The Study on the Deployment of AI in Healthcare (Final Report) finds that European...
A new Standard Operating Procedure (SOP) titled “Validation, Publication, and Maintenance of Real-World Data Sources and Studies in the HMA-EMA RWD Catalogues” (SOP/TDA/3543) has been published by the European Medicines Agency (EMA). This SOP outlines the systematic...
The European Commission has opened a public consultation to gather feedback on the implementation of the AI Act's rules concerning high-risk AI systems. The aim is to collect practical examples, clarify open questions, and inform upcoming Commission guidelines on the...
The European Medicines Agency (EMA) has issued its first Qualification Opinion (QO) on an AI-based tool for clinical research. The tool, AIM-NASH, assists pathologists in analysing liver biopsies to assess the severity of MASH (Metabolic dysfunction-associated...
Fondazione Gianni Benzi is pleased to share the participation of our Head of Research and Innovation Department, Viviana Giannuzzi, at the World Orphan Drug Congress 2024, held in Barcelona from October 22-25. Viviana gave a lecture on the work done by Fondazione...
On 13 March the European Parliament adopted the world’s first binding law on artificial intelligence (AI). This legislation sets out clear guidelines for the use of AI technologies, aiming to ensure their responsible and ethical deployment. More specifically, the law...
On 18 January, the World Health Organization (WHO) has released a new guidance document aimed at governing the ethical utilisation of Large Multi-modal Models (LMMs) in healthcare. Unlike conventional AI models, LMMs can process various forms of data inputs and...
EMA published a draft reflection paper on the use of artificial intelligence to support the safe and effective development, regulation and use of human and veterinary medicines.
The workshop “L’intelligenza artificiale a tutela della salute in età pediatrica. Implementazione di una piattaforma digitale per il design di farmaci pediatrici sicuri” will be held on Thursday 30 March 2023 at 9:00 in Bari, Italy.
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