Speakers
Sue Fitzpatrick
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 and Irrum Afzal
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.
Irrum Afzal is a graduate of Imperial College London and a recipient of the National Orthopaedic Alliance (NOA) Director’s Award. In addition to her academic qualifications, Irrum holds both PRINCE2 Practitioner and Foundation certifications, demonstrating strong project management expertise. With experience in both the NHS and the private healthcare sector, Irrum has contributed to a range of digital health transformation initiatives. She brings a unique blend of research and operational insight, enabling her to effectively manage multidisciplinary teams and deliver high-impact healthcare, research, and quality improvement projects.
Irrum holds multiple positions of national responsibility, reflecting her commitment to healthcare leadership, innovation, and advancing high-quality, patient-centred care. Her positions of responsibility include Vice Chair of Research and Innovation for the NOA, Professional Member of the Research Ethics Committee for the Health Research Authority (HRA), Research Committee Representative for the British Orthopaedic Sports Trauma and Arthroscopy Association (BOSTAA), and BOSTAA Equality, Diversity, and Inclusivity Lead, Orthopaedic Data Evaluation Panel Member. Irrum is a Non-Executive Board Member of the Orthopaedic Research and Education Foundation (OREF). She also plays an active role in the Imperial College Alumni Service.
Her interests include Patient Reported Outcome Measures (PROMs), Evidence-Based Medicine, and Artificial Intelligence. Irrum has published in various peer-reviewed journals, frequently presents at national and international meetings, and is a reviewer for The Bone & Joint Journal.