In recent years, numerous medicines regulatory agencies have shown an increasing willingness to consider real-world evidence (RWE) to support claims of efficacy, effectiveness, and safety. RWE derived from the review and analysis of real-world data (RWD). This shift...

In May 2024, the International Council for Harmonisation (ICH) released the M14 guideline “ICH M14 Guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines. This...

The European Paediatric Translational Research Infrastructure (EPTRI) will hold its General Assembly and Scientific Meeting on 18 and 19 July in Bari, Italy. This key event will bring together researchers, industry representatives, healthcare professionals and patient...

Between 4 and 6 June 2024, 140 people from c4c beneficiaries met in Bergen, Norway, for the c4c General Assembly. This meeting was a great opportunity for colleagues to meet again and collaborate further for the benefit of the c4c network. The aim of this meeting was...

Today, June 19th, marks World Sickle Cell Day, an opportunity to raise awareness about a rare blood disorder that affects millions of people worldwide. Fondazione Gianni Benzi, committed to research and improving the lives of patients, reaffirms its dedication to the...

Privacy protection in scientific research is a crucial issue that is constantly evolving due to technological advances and new ethical challenges. In Italy, Article 110 of Legislative Decree 101/2018, which transposes the GDPR, has undergone recent amendments that...

On May 27, 2024, the results of the Early Anti-Retroviral Treatment in Children (EARTH) study on HIV-related events was published in eClinical Medicine, part of THE LANCET Discovery Science. The EARTH paediatric clinical study was carried out in the context of the...

The final conference of the EJP RD (European Joint Programme on Rare Diseases) project was held in Bari, Italy, on 27 and 28 May, 2024. More than 150 researchers, clinicians, patients, research funders and industry representatives joined the event sharing the most...

Two new papers featuring our researcher Annalisa Landi as one of the authors and released in the framework of the European Joint Programme on Rare Diseases (EJP RD), have been published in the journal Nature. These papers propose a new way to responsibly share...

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...