Professor Dr DAVID HUTCHINSON, BSc, PhD, CBiol, FRQA, FICR
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.
David is founder and Academic Dean (responsible for maintaining training quality and certification standards) of Brookwood International Academy.
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.
He has developed and maintained numerous clinical research and GCP training programmes for commercial clients. He undertakes quality assurance of training material.
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:
- Essential Good Clinical Practice
- 12 Golden GCP Rules for Investigators (available in English, French, German, Polish, Bulgarian, Russian, Spanish, Japanese, Czech, Turkish and Chinese versions)
- 10 Golden GCP Rules for Pharmacists
- 15 Golden IND/GCP Rules for Investigators
- How Drugs are Developed, a practical guide to clinical research
- Dictionary of Clinical Research
- Interpreting Medical Records" (with Graham Hornett)
- 12 Golden GCP Rules for Veterinary Studies (with Kathy Garden)
- 12 Golden ISO14155 Rules for Studies on Medical Devices (with Joris Bannenberg).
He has recently written, narrated and developed an online GCP training programme (three modules) with online examination and certification, accredited by the Faculty of Pharmaceutical Physicians (Royal Colleges of Physicians of the United Kingdom).
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 was President of the Association of Clinical Research Professionals (Europe) in 2000 and delivered the keynote presentation to their Annual Conference in Brussels, September 2004. David is a Fellow of the Institute of Clinical Research and a Fellow of Research Quality Assurance.
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 Basle) 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), has RYA Yachtmaster powerboat qualifications, is a Football Association Referee Instructor and assessor, watches Nottingham Forest, loves curry's and likes a game of golf.
Dr Colin R. Wilsher, BA (Hons), PGCE, PhD, AFBPS, FRQA
Senior Training Associate
Colin Wilsher is a freelance GCP expert and frequently presents at the Brookwood International Academy training courses. He has spent the last ten years working for the clinical auditing group of Pfizer Medical as a GCP auditor and then as Director and Regulatory Intelligence Lead in the Inspection Management group of Medical Quality Assurance at Pfizer.
He qualified as a Chartered Psychologist in the late 1970's and went on to do a PhD in Neuropsychopharmacology at Aston University, UK. Whilst at Aston University he was an investigator leading two randomised placebo controlled clinical trials of a Nootropic drug treatment of developmental dyslexia. He also has a teaching degree (PGCE) and completed Post Doctoral studies at the Department of Psychiatry, Rutgers Medical School, New Jersey, USA. For four years he worked for a US subsidiary of the Belgium pharmaceutical company (UCB Pharma Inc) in the USA, as a Clinical Development Coordinator running Phase III studies across the USA. Following this he went on to work, in the UK, for 16 years for UCB Pharma Ltd. His roles included working in; Regulatory Affairs (a member of BIRA /TOPRA) from 1990 to 2002); CNS Therapeutic Group; and Local Clinical Quality. In 2002 he joined Pfizer clinical quality assurance group as a clinical auditor and GCP Technical Specialist.
Colin has served on the Regulatory Authority MHRA GCP Consultative Committees from its inception until 2010. He has also served on the MHRA Risk Based Inspection Stakeholder group and the MHRA Risk Adaptation Consultative Group.
He joined RQA (Research Quality Association, formally the British Association for Research Quality Assurance, BARQA) as a member in 1994; has been an active member of the GCP Committee for many years; was twice elected Chairman of the GCP Committee; and is a Fellow of Research Quality Assurance (FRQA). In 2013 he was honoured with the prestigious "RQA Award for 2013".
He is an active member of the Audit Working Party of EFGCP (European Forum for Good Clinical Practice) and for 5 years was a member of the EFGCP Ethics Working Party.
He was on the editorial board of the Quality Assurance Journal (QAJ) and is a senior correspondent of the CQAdvisor.
Also he holds an honorary faculty position in the School of Psychology at the University of Wales.