ICH GCP training – what are the expectations?

The International Council for Harmonisation (ICH) guideline on Good Clinical Practice (GCP) E6 revision 3 has now been published. The Danish Medicines Agency anticipate questions regarding the need for training and retraining and therefore publish this Q&A.

Appropriate and adequate training on ICH GCP E6 R3 is essential because it helps maintain compliance with regulatory requirements, enhances the quality and reliability of clinical trial data, and ensures the protection of trial participants.

You can find the Q&A on our webpage.

Don't miss our information meeting on the revised ICH GCP guideline

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. It is still possible to sign up for participation and the event will also be open for livestreaming. You can find more information on our newspage.