by adminBenzi | Dec 19, 2024 | News
The update of the ICH E6 (R3) guideline on Good Clinical Practice (GCP) is currently in its final stages and is expected to come into force during 2025. Its final release will depend on the regulatory authorities of each country involved in the ICH. Since the first development of the guideline in 1996, there has been one major revision: ICH E6 (R2), published in 2016. This update addressed significant changes in the clinical research landscape, including the... 
by adminBenzi | Dec 13, 2024 | News
Gaps exist in regulatory science that need to be addressed to improve medicine development and evaluation, ultimately to enable access to innovative medicines that address patients’ needs. The European Medicines Agency (EMA) has outlined approximately one hundred topics in its published "Regulatory Science Research Needs" list. By sharing this list, the EMA aims to encourage researchers and funding bodies to integrate these priorities into their projects and... 
by adminBenzi | Dec 11, 2024 | News
The European Rare Diseases Research Alliance (ERDERA) has officially launched the 2025 Joint Transnational Call for Proposals focused on “Pre-clinical therapy studies for rare diseases using small molecules and biologicals – development and validation”. This initiative aims to foster international collaboration and innovation to address critical unmet needs in rare disease research. Researchers are invited to submit project proposals that align with the call’s... 
by adminBenzi | Dec 9, 2024 | News
We are happy to announce the publication of a new scientific article titled “shaSharing Data and Transferring Samples Within Pediatric Clinical Studies: How to Overcome Challenges and Make Them a Science Opportunity” in the MDPI Helathcare journal. This work, conducted within the framework of the EPIICAL consortium, features contributions from our researchers Annalisa Landi, Viviana Giannuzzi, and Adriana Ceci, highlighting our collaborative dedication to... 
by adminBenzi | Dec 6, 2024 | News
The European Medicines Agency (EMA) has launched a public consultation on the draft chapter dedicated to real-world data (RWD) within the Data Quality Framework for EU medicines regulation. This is essential for advancing the use of real-world evidence in regulatory decisions. The draft RWD chapter aims to provide guidance on evaluating the quality of real-world data in medicines assessment. Moreover, it offers recommendations on employing metrics to assess data... 
by adminBenzi | Dec 3, 2024 | News
Fondazione Gianni Benzi is delighted to announce that applications are now open for the Second-Level Master’s Programme in Regulatory Sciences - G. Benzi, organised by the Department of Biology and Biotechnology "Lazzaro Spallanzani" of the University of Pavia. This internationally renowned programme offers a unique opportunity to gain advanced expertise in regulatory sciences and prepare for a career in the regulatory, pharmaceutical, and biotechnological... 
