Auditing

Navigating ICH E6(R3): A New Era for Clinical Trials

Navigating ICH E6(R3): A New Era for Clinical Trials

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...

Insights and Compliance Strategies for Pharmacovigilance Under the Windsor Framework

Insights and Compliance Strategies for Pharmacovigilance Under the Windsor Framework

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)...

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