Live streaming of the Danish Medicines Agency's after-work meetings 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 registration for on-site participation in the meetings have closed but the meetings will be live streamed without a requirement for prior registration. They will be recorded for internal use only. The microphones and cameras of the participants will be turned off by default.

The meeting on February 27, 2025, will primarily be held in Danish, while this meeting on February 28, 2025, primarily will be held in English.

Link for streaming the Danish meeting on 27 February 2025:
https://teams.microsoft.com/l/meetup-join/19%3ameeting_YWVlYmE3ZWQtZmYxMi00NzIzLTk4MTktNjQwNTZiMTg2N2I4%40thread.v2/0?context=%7b%22Tid%22%3a%22ce697522-be9a-4330-a186-65a5d9a7ad5d%22%2c%22Oid%22%3a%22e483451a-8104-4f74-9c86-e4a7fed8646c%22%7d  

Link for streaming the English meeting on 28 February 2025:
https://teams.microsoft.com/l/meetup-join/19%3ameeting_NjY0ODZkYTgtMjU0NS00OGI5LWJlMTUtMTc0YzgzYjdiOTJk%40thread.v2/0?context=%7b%22Tid%22%3a%22ce697522-be9a-4330-a186-65a5d9a7ad5d%22%2c%22Oid%22%3a%22e483451a-8104-4f74-9c86-e4a7fed8646c%22%7d

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. A special focus will be given to the area of data governance i.e. sections 2.12, 3.16 and 4. 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.