As a Lead Senior GCP Inspector at the UK Medicines and Healthcare products Regulatory Agency (MHRA), I thought it would be useful to write about the changes to the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline …
The International Council for Harmonisation (ICH) Expert Working Group for ICH E6(R3) (EWG) has been updating the ICH E6(R2) Good Clinical Practice (GCP) guideline. The E6(R3) overarching principles, Annex 1, Glossary and 3 Appendices will replace the current E6(R2). These …
I write this blog post just after returning from the 2023 MHRA GMP Symposium in London. It has been more than two years since we held our last event virtually, and over three years since we were face-to-face for the …
The first hybrid GMDP Symposium was held on 21-22 February 2023. For the first time, we offered delegates the opportunity to either watch the event online from the comfort of their homes or to join us in person in West …
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