Clinical Research and GCP Update

PROFESSOR DR DAVID HUTCHINSON Professor Dr David Hutchinson is a well- known and respected teacher of clinical research and GCP with considerable experience of clinical trial management and regulations. He has made a significant contribution to the field of training and the professional development of clinical research and quality assurance professionals and has delivered presentations worldwide. He is Visiting Professor in Clinical Research & GCP in the Faculty of Health & Medical Sciences, University of Surrey and provides clinical research training for undergraduate and postgraduate students. Since 1985 he has designed and delivered training programmes, some with certification, to thousands of clinical researchers (sponsors, investigators) worldwide. He has taught GCP responsibilities to investigator sites, and regulatory authority personnel, throughout Europe and extensively in Eastern Europe. He has trained members of the Saudi FDA and MHRA as well as other EU regulators. He has provided GCP training to hundreds of medical professionals in conjunction with the Dubai Ministry of Health and Al Jalila Foundation, Dubai, UAE. He has developed and delivered numerous clinical research and GCP training programs for both commercial and academic clients. As well as being principal author and editor of Clinical Research and Quality Assurance ‘Advisor’ newsletter, David is author of numerous books and articles on clinical research and QA topics including: • 12 Golden GCP Rules for Investigators (available in English, French, German, Polish, Bulgarian, Russian, Spanish, Japanese, Czech, Turkish and Chinese) • 10 Golden GCP Rules forPharmacists • 12 Golden ISO14155 Rules for Studies on Medical Devices (withJoris Bannenberg) • PV for ALL: a guide to recognizing and reporting product safety information (with Lisbeth Tofte Hemmingsen) He has written, narrated and developed numerous online GCP training programmes with testing and certification, accredited by the Faculty of Pharmaceutical Physicians (Royal Colleges of Physicians of the United Kingdom) – now available in 14 languages. David was founding editor of the British and European Journal of Clinical Research, the British Journal of Medical Economics and Good Clinical Practice Journal. He is a former President and life member of the Association of Clinical Research Professionals. David is a Fellow of Research Quality Assurance (RQA). In the past, David has taught GCP to members of the UK’s national and local ethics committees as well as on the European course in Pharmaceutical Medicine (ECPM, University of Basel) and the Kings College London course on Ethical Principles. David has completed an ISO9000 training course with continuous assessment and examination in Quality Assurance Auditing (Auditor/Lead Auditor). Outside clinical research David is a Certified NLP Master Sports Practitioner (mental performance coaching) and coaches numerous professional golfers. He has RYA Yachtmaster powerboat qualifications, is a Football Association Referee Coach and professional game referee observer. He supports Nottingham Forest, loves curry’s and enjoys a game of golf (but only in the sun!) when time permits! David is founder and owner of Brookwood International Academy. • • Essential Good Clinical Practice Essential Pharmacovigilance (with Lisbeth TofteHemmingsen)