Information meeting on the revised ICH GCP guideline (ICH E6 R3)
The Danish Medicines Agency will hold after-work meetings on the revised ICH GCP guideline (ICH E6 R3) on February 27 and 28, 2025, from 14:30 to 18:00. The meetings will be conducted by ICH E6 R3 EWG member and GCP inspector Lisbeth Bregnhøj in the Danish Medicines Agency’s canteen, Axel Heides Gade 1, 2300 Copenhagen S.
The principles and Annex 1 of the guideline are expected to be approved and published by the end of 2024 and will come into effect 6 months thereafter. Sponsors of clinical trials should prepare for the implementation of ICH E6 R3 principles and Annex 1 during the interim period.
Annex 1 addresses general requirements for clinical trials. Annex 2 of the guideline, which covers additional considerations regarding decentralised elements in clinical trials and pragmatic trials, is currently under public consultation and will be approved and implemented at a later date. Therefore, Annex 2 will not be the focus of the meetings.
R3 is a complete rewrite of the existing R2 to provide the necessary flexibility regarding new trial types and data sources. Additionally, the rewrite will close gaps with existing ICH guidelines such as ICH E9 on statistical principles in clinical trials. The structure of the guideline has been changed and includes, among other things, expanded principles, a new section on data integrity and management, and a major revision of sections on essential records. Furthermore, there have been significant changes in the sections on the responsibilities of investigators and sponsors respectively.
The after-work meetings will cover the background of the changes, the structure of the revised guideline, and a review of the principles and individual sections in Annex 1 with a focus on changes from R2 to R3. There will be time allocated for questions.
The meetings should be seen as a supplement to the official ICH training material, which will be published later in 2025, as well as the EU stakeholder meeting to be held on February 19 and 20, 2025 ACT EU workshop on ICH E6 R3 (principles and Annex 1) | European Medicines Agency (EMA)
The presentations are written in English, as it is the language of the guideline.
The meeting on February 27, 2025, will primarily be held in Danish, while the meeting on February 28, 2025, primarily will be held in English.
Participation in the meeting requires registration at Send an email on a first-come, first-served basis, with some consideration given to the number of participants per organisation and with the latest registration date being February 7, 2025. Please remember to specify which day the registration concerns.