Speakers
BOA Session
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.
Speaker/ Course Lead:
Irrum Afzal
Irrum Afzal is an Imperial College London graduate and a recipient of the National Orthopaedic Alliance (NOA) Director’s Award. In addition to her academic qualifications, she holds both PRINCE2 Practitioner and Foundation certifications, demonstrating strong project management expertise.
With experience spanning both the NHS and private healthcare sectors, she brings a unique blend of research and operational insight, effectively delivering and managing numerous healthcare and research projects. Irrum has supported and overseen the delivery of multiple studies in compliance with regulatory frameworks and governance requirements. Her work is underpinned by a strong commitment to Good Clinical Practice (GCP). As a Professional Member of the Research Ethics Committee for the Health Research Authority (HRA), she holds a nationally significant role in safeguarding the ethical and scientific integrity of clinical research in the UK. Drawing on her extensive experience in the practical application of Good Clinical Practice (GCP) principles, she provides reviews clinical and non-clinical research ethical applications involving human participants, tissues, or data ensuring that all studies are ethically and methodologically robust, and that the rights, safety, and dignity of participants are fully protected. Irrum has published in various peer-reviewed journals, frequently presents at national and international conferences, and serves as a reviewer for The Bone & Joint Journal.
Irrum holds multiple positions of responsibility, including Vice Chair of Research and Innovation for the NOA, Board Member for OrthoAI (ORAIA), Research Committee Representative for the British Orthopaedic Sports Trauma and Arthroscopy Association (BOSTAA), and Equality, Diversity, and Inclusivity Lead for BOSTAA. She is also a Non-Executive Board Member of the Orthopaedic Research and Education Foundation (OREF), and plays an active role in the Imperial College Alumni Service.