GCP-courses recognition by swissethics: Adaptation to the Principles and Annex I of the revised ICH E6(R3), to the Declaration of Helsinki and to ISO/DIS 14155
25.02.2025
swissethics reminds GCP course providers to update their courses to the Principles and Annex 1 of the revised ICH E6(R3), to the updated Declaration of Helsinki of October 2024, and to ISO/DIS 14155 «Clinical investigation of medical devices for human subjects – Good clinical practice». The latter is still in the consultation phase with ISO members. While the exact timeline for the release and enforcement of the revised ISO/DIS 14155 has not been officially announced, it is expected to be published within the coming months. swissethics will require confirmation of the updates after Annex 2 ICH E6(R3) enters into force in the first half of 2026.