Speakers
BOA Session
Hall 1 - Main Auditorium
The first part of the session (08:30 - 10.00) 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 changes on investigator sites and sponsors. The current legislation relating to clinical trials and medical devices will also be discussed.
Sue Fitzpatrick is the former Director and Head of Education and Training of the Institute of Clinical Research and has more than 30 years’ experience within clinical research. She was responsible for the management, audit and training of CRAs and has developed many training and academic courses. She currently is module leader for the research methods module QMUL. Sue continues her work on enhancing competencies and standards architecting the gold and training standards for CRAs. Currently Sue is a consultant to Health Education England, the end point assessor for the new clinical research degrees.
She was a member of the GCP committee of the Faculty of Pharmaceutical Medicine and helped develop a certification examination for physicians and other research personnel. She has authored many articles and books on clinical research, career development and risk based monitoring topics. Sue co-authored The Oxford Handbook on Clinical and Healthcare Research published by the Oxford University Press