New clinical trial map launched in the EU
[📢New clinical trial map launched in the EU ] EMA has just announced that a new clinical trial map is accessible from the public website of the Clinical Trials Information System (CTIS). The map is designed to provide patients and health care professionals with easy...
ACT EU workshop on ICH E6 R3 – broadcast details and Slido
Dear participants, Thank you for your interest in participating in upcoming ACT EU workshop on ICH E6 R3. Due to the high level of interest, the programme committee has decided that participants joining remotely should access the broadcast the event, accessible via...
Forwarding Information – public consultation on the 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 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...