Navigating the Transition from ISO 14155:2020 to ISO 14155:2025 – Changes and Challenges

Providing an overview of implementation timelines and focus the ISO 14155:2025 update
Highlighting changes to risk management processes for clinical investigations, including their impact on AE reporting
Discussing new requirements for suspension and termination of clinical investigations
Addressing the impact of changes to statistical requirements
Giving context to the estimand framework (ICH E9 (R1)) that is now referenced in Annex K
Providing considerations towards preparation for transition to ISO 14155:2025