The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics. Read in full HERE
The vision on Big Data is a strengthened regulatory system that can efficiently integrate data analysis into its assessment processes to improve decision making. Knowing…
ICH has published a new Reflection Paper: International Harmonisation of Real-World Evidence Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using…
The OECD has published its Advisory Document on GLP & Cloud Computing – Supplement 1 to Document Number 17 on Application of GLP Principles to…
ICH recently released a new draft of the ICH E6 (R3) guidelines. While the finalised version is set for release at the end of 2023, we can…
As FDA considers the application of its risk-based regulatory framework to the use of AI technologies in drug manufacturing, it has identified in this discussion paper areas…
The MHRA has updated its published âGuidance on Borderline Products: How to Tell if your Product is a Medical Device and which Risk Class Appliesâ.…
Andrew Fisher, Lead Senior GCP Inspector, has written a blog about the changes to the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP)…
This newly published European Medicines Agency âQuestions and Answers Documentâ provides answers to commonly asked questions about the proof-of-concept pilot on the submission and analysis…
An updated version of the DPCâs Preservation Toolkit has been shared, which improves the previous version by building on the work and feedback of their…