by adminBenzi | Aug 22, 2024 | News
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 is transforming the regulatory environment, emphasising the importance of RWE in decision-making processes. A new consensus report by the Council for International Organizations of Medical Sciences... 
by adminBenzi | Aug 19, 2024 | News
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 guideline focuses on the planning, design, and analysis of pharmacoepidemiological studies using real-world data (RWD) for the safety assessment of medicines, thus aligning global practices and... 
by adminBenzi | Jul 16, 2024 | News
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 advocacy groups to discuss the latest advances in paediatric research and how EPTRI can provide support through its specialised services. The European Paediatric Translational Research Infrastructure... 
by adminBenzi | Jul 4, 2024 | News
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 to provide an update on progress to date and to discuss plans for the future of c4c, particularly now that the conect4children Stichting (c4c-S) has been established to support the c4c network and... 
by adminBenzi | Jun 19, 2024 | News
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 fight against this disease. Sickle cell anemia is an inherited condition that alters the shape of red blood cells, making them rigid and sickle-shaped. This deformation impedes blood flow, causing... 
by adminBenzi | Jun 12, 2024 | News
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 deserve careful consideration. Article 110 provides a set of stringent requirements for retrospective studies, those using data collected in the past, for which it is considered difficult to obtain... 
