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Top benzifoundation.org News

EMA strategy to optimise use of data and artificial intelligence (AI) - Fondazione Gianni Benzi Onlus
Artificial Intelligence · Italy

EMA strategy to optimise use of data and artificial intelligence (AI) - Fondazione Gianni Benzi Onlus

The European Medicines Agency (EMA), together with the Heads of Medicines Agencies (HMA), has published a joint workplan "Data and AI in medicines regulation to 2028" to harness data and tools to drive research, support regulatory decisions, and accelerate access to better medicines. The workplan aims to improve data sharing, quality, and interoperability across the EU regulatory network, while upholding high security and ethical standards. It s…Read Article
Calls for inclusion of pregnant and breastfeeding participants in clinical trials - Fondazione Gianni Benzi Onlus
Bari, Apulia · Bari

Calls for inclusion of pregnant and breastfeeding participants in clinical trials - Fondazione Gianni Benzi Onlus

The European Medicines Agency (EMA) has published a new draft guideline offering key recommendations for the inclusion and retention of pregnant and breastfeeding individuals in clinical trials. This initiative aims to support the generation of robust clinical data in these populations, enabling more informed, evidence-based treatment decisions. Developed through the International Council for Harmonisation (ICH), this guideline underscores that …Read Article

A Causal Discovery Workflow for Rare Diseases: Experts-in-the-Loop Analysis of Sparse Longitudinal Data

Causal networks provide a mechanistic understanding of clinical phenomena, allowing for personalized and explainable decision-making. Causal discovery, namely the task of constructing such models, is challenging, particularly for rare diseases, where observational data are sparse, medical knowled...Artificial IntelligenceSee the Story

Have your say: EMA-EU plans for electronic product info for medicines - Fondazione Gianni Benzi Onlus

The European Medicines Agency (EMA) has launched a public consultation to collect input for a reflection paper on patient access to electronic product information (ePI). The ePI is the future electronic product information for medicines, and it is the outcome of a joint EMA-Heads of Medicines Agencies (HMA)-EC collaboration to facilitate informed decision-making by patients and healthcare professionals and improve overall patient safety. The ePI…MedicalRead Article

Italy promotes animal research transparency initiative - Fondazione Gianni Benzi Onlus

Animal research remains essential for medical progress, despite ongoing efforts to develop alternative methods. Following an initiative by the National Committee for the Protection of Animals Used for Scientific Purposes, the Italian Ministry of Health  is promoting the Transparency Agreement on Animal Research. The agreement invites institutions that conduct animal-based scientific research to publicly commit to greater openness about when, how…Italy · ItalyRead Article

Promoting gender equality in research: FGB at COST Connect - Fondazione Gianni Benzi Onlus

Fondazione Gianni Benzi participated in the COST Connect – Gender Equality Plans in COST Actions event, held in Brussels on 13 May 2025. The initiative, organised by COST (European Cooperation in Science and Technology), represented an important opportunity for dialogue among COST Actions members committed to promoting gender equality in research and innovation. The Foundation was invited to participate in the event due to its responsibility for…Brussels · BrusselsRead Article

New EU rules on Health Technology Assessment - Fondazione Gianni Benzi Onlus

Following a public consultation period, the Regulation on Health Technology Assessment (HTA) has been officially published and entered into force. The new rules establish a permanent EU framework for the joint clinical assessment of health technologies, such as medicines and medical devices. By encouraging collaboration between Member States, the Regulation will support quicker and more consistent decision-making on pricing and reimbursement at …MedicalRead Article

EMA boosts 3Rs in drug testing - Fondazione Gianni Benzi Onlus

The EMA (European Medicines Agency) “Reflection paper on the current regulatory testing requirements for human medicinal products and opportunities for implementation of the 3Rs” has been developed as a follow-up to the 2016 “Guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches”. Its aim is to incorporate newly developed 3Rs (replacement, reduction, refinement) approaches that are no…Bari, Apulia · BariRead Article

New EDPB guidance on age assurance and data protection - Fondazione Gianni Benzi Onlus

On 11 February 2025, the European Data Protection Board (EDPB) has released a new statement outlining key principles and concerns regarding age assurance measures on online platforms. The document provides guidance for organisations implementing age verification and estimation technologies while ensuring compliance with EU data protection laws, including the General Data Protection Regulation (GDPR). The EDPB highlights the need for a privacy-pr…Bari, Apulia · BariSee the Story

World Thalassaemia Day 2025 - Fondazione Gianni Benzi Onlus

8 May is the World Thalassaemia Day, a major opportunity to raise public awareness about this blood disorder that affects millions of people worldwide. Thalassaemia is a type of haemoglobinopathy, a genetic condition that impairs the production of haemoglobin – the protein in red blood cells responsible for transporting oxygen. This condition can lead to chronic anaemia and complications that often require medical care, including regular blood t…Italy · ItalyRead Article

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