ICH E6(R3) final principles & Annex 1 published
We are pleased to announce that the ICH E6(R3) principles and Annex 1 have been finalised and published on the ICH website. This is a rewrite and reorganisation of the R2 version of the guideline on Good Clinical Practice (GCP), which sets international standards for...
Launch of MSP AG consultation on clinical trials training needs for academia and SMEs | Deadline 11 February 2025 (close of business)
We are pleased to announce the launch of the ACT EU consultation on clinical trials training needs for academia and SMEs. As a reminder, the consultation stems from ACT EU initiative’s Priority Action on clinical trials training aiming to deliver a clinical trials...
ICH M15 Guideline on general principles for model-informed drug development
The European Medicines Agency has published for public consultation the ICH M15 Guideline on general principles for model-informed drug development. This guideline provides general recommendations for planning, model evaluation, and documentation of evidence derived...
ICH Guideline for Good Clinical Practice E6(R3) Annex 2
The European Medicines Agency has published for public consultation the ICH Guideline for Good Clinical Practice E6(R3) Annex 2 Good Clinical Practice (GCP), as described in ICH E6(R3) Principles and Annex 1, is applicable across clinical trial types, designs and...