Speakers
External Organisation
This session will describe the purpose of Good Clinical Practice (GCP) and outline the significant milestones in the history of GCP development. It will look at the impact of ICH GCP E6 R3 changes on investigator sites and sponsors. The current legislation relating to clinical trials and medical devices will be discussed. The practical application of GCP will be reviewed.
Course Lead: Sue Fitzpatrick
Sue Fitzpatrick is the former Director and Head of Education and Training at the Institute of Clinical Research and brings more than 40 years of experience in clinical research. She has led the management, audit, and training of Clinical Research Associates (CRAs) and has developed numerous academic and professional training programmes. Sue currently serves as Module Leader for Research Methods at Queen Mary University of London (QMUL) and continues to advance competency and training standards within clinical research.
She is a consultant for NHS England, an end-point assessor for clinical research degrees, and Lead Governor for North Cheshire and Merseyside NHS Foundation Trust. Sue has contributed extensively to Good Clinical Practice (GCP) standards through her work with the Faculty of Pharmaceutical Medicine and has authored numerous articles and books, including co-authoring The Oxford Handbook of Clinical and Healthcare Research published by Oxford University Press.