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ICH E6 rewritten to reflect recent GCP inspection findings

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Author

Dr Colin Wilsher, RQA GCP Committee

Colin 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 Inteligence 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 subsidary of the Belgium pharmaceutical company (UCB Pharma Inc) in the USA, as a Clinical Development Coordinator running Phase 111 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 BIRTA/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 Speciaist.
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 Adaption Consultative Group.
He joined RQA (formally BARQA) as a member in 1994; has been an active memver 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 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.
Colin also holds an honorary faculty position in the School of Psychology at the University of Wales.