Clinical Research and GCP Update

DR COLIN WILSHER Colin Wilsher is a well-known GCP expert and is a mainstay of Brookwood’s training courses and regulatory intelligence for the ‘Advisor’ newsletter. Colin also manages the @GCPadvisor Twitter account. Prior to becoming freelance and setting up a GCP consultancy, he worked for ten years in 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 a Clinical 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 3 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 and becoming a Director of Regulatory Intelligence. Colin has served on the UK Regulatory Authority MHRA GCP Consultative Committees from their 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 "Research Quality Association Award for 2013" and in 2019 was awarded an Honorary Life Fellowship of RQA. He was 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 ‘Advisor’ newsletter. Colin held an honorary faculty position in the School of Psychology at the University of Wales 1998 to 2018.