The Story of ICH-GCP: An introduction for investigators and site staff Clinical Trials in Resource-Limited Settings

Dr Roma Chilengi, Head of Clinical Trials at the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya gives an introduction to ICH-GCP. This overview covers the historical background, context and evolution to ICH-GCP, summarises its key principles and describes the role of regulatory authorities. The talk highlights some of the accomplishments of ICH-GCP but also critiques some aspects of GCP application in non-pharmaceutical settings.