53 – ICH Guidelines and Global Harmonization (S21E4)

This is a dive into ICH guidelines, specifically E6(R2), which is a corner stone of current Good Clinical Practices, that shapes cGCP worldwide. We discuss the reasoning behind harmonization efforts and the way these standards are influencing national regulations.This also discusses that ICH Guidelines, particularly the E6 R2 guideline, is about ensuring that clinical trials are conducted ethically. There is a focus on patient safety throughout every step. Practical implications for multinational trials and compliance strategies will be covered throughout this podcast episode.