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...
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...
