by adminBenzi | Mar 10, 2025 | News
On 5 March 2025, the European Union officially published the European Health Data Space (EHDS) Regulation (Regulation (EU) 2025/327), marking a significant step towards a unified framework for electronic health data across member states. The Regulation establishes a harmonised legal and technical framework for Electronic Health Records (EHR) systems, fostering data interoperability. Specifically, an EU dataset catalogue connecting the national dataset catalogues... 
by adminBenzi | Mar 3, 2025 | News
The Committee on Public Health (SANT) has launched a public consultation to gain a deeper understanding of the challenges faced by people living with rare diseases and to gather insights from those working in or involved with this field. Taking part is crucial as experiences, ideas, and suggestions provided will help shape the Committee’s future work on rare diseases and contribute to better policies and support. This survey is voluntary and anonymous and is open... 
by adminBenzi | Feb 24, 2025 | News
After two rounds of public consultations, the EMA adopted the Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials, which will enter into force on 1 July 2025. The guideline explains how to organise and submit information for a clinical trial application involving advanced therapy medicinal products (ATMPs). It covers both early-stage (exploratory) and later-stage (confirmatory)... 
by adminBenzi | Feb 19, 2025 | News
We are excited to announce a new publication on paediatric post-authorization studies (PASs). The study, authored by Annalisa Landi, Antonella Didio, Annunziata D’Ercole, Adriana Ceci, and Fedele Bonifazi is now available in MDPI Pediatric Reports. PASs play a crucial role in the post-authorization phase of a drug. They help confirming the benefit–risk profile of drugs in real-world settings and detecting long-term or rare adverse events that may not have been... 
by adminBenzi | Feb 18, 2025 | News
The GDPR introduces the concept of ‘pseudonymisation,’ highlighting it as a potential safeguard for ensuring compliance with data protection requirements. The EDPB guidelines clarify its definition, applicability, and benefits, explaining how it supports key GDPR obligations, including data protection principles (Article 5), data protection by design and default (Article 25), and security measures (Article 32). Additionally, the guidelines outline technical... 
by adminBenzi | Feb 5, 2025 | News
We are pleased to announce a new publication in Frontiers in Medicine. It is titled “Effects of the Paediatric Regulation funding on the development of off-patent medicines in children”. The authors Lucia Ruggieri, Silvia Torretta, Viviana Giannuzzi, Adriana Ceci, and Fedele Bonifazi explored key issues in paediatric drug development. The study discusses challenges in developing and authorizing paediatric medicines. It emphasises the importance of the regulatory... 
