Understanding the transformative impact of ICH E6(R3) guidelines on clinical trial oversight and quality management. Introduction In the ever-evolving landscape of clinical trials, the recent update to the ICH E6(R3) Good Clinical Practice (GCP) guidelines...
The implementation of the Windsor Framework on January 1, 2025, marked a significant regulatory milestone for the UK pharmaceutical industry, particularly in pharmacovigilance (PV). For the first time, the Medicines and Healthcare Products Regulatory Agency (MHRA)...