The MHRA has updated its published “Guidance on Borderline Products: How to Tell if your Product is a Medical Device and which Risk Class Applies”.…
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 ‘Questions and Answers Document’ provides answers to commonly asked questions about the proof-of-concept pilot on the submission and analysis…
An updated version of the DPC’s Preservation Toolkit has been shared, which improves the previous version by building on the work and feedback of their…
Artificial Intelligence writers and chatbots have seen huge success following a boom started by ChatGPT since its launch in November 2022. As ChatGPT grows so…
It’s unlikely that Bob Dylan was writing about the trial master file in his 1964 hit song, “The Times They Are a-Changin”. And yet, 59…
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two new Good Distribution Practice (GDP) guidance documents that came into force in Feb 2023 The documents…
The FDA has released its BIMO inspection metrics for year 2022. These metrics give you useful information on inspections performed throughout 2022 and observations raised…
GMP and GCP Inspectors work closely with MHRA Clinical Trials and regularly provide support to help answer a wide range of stakeholder queries which relate…
The EU is introducing more time to certify certain medical devices under EU Medical Device Regulation (“EU MDR”). The proposal recognises the challenges in capacity…