ICH E6(R3): a new era for Good Clinical Practice in industrial pharmacy
The latest revision of the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice (GCP), ICH E6(R3), represents a significant advancement in the regulation of clinical trials. This update introduces a modernized, risk-based, and flexible approach to trial conduct, aiming to enhance data integrity, patient safety, and operational efficiency. This article examines the key changes in ICH E6(R3), focusing on its impact on industrial pharmacists involved in clinical research and drug development.