Mark Poulton
ex MHRA Inspector
BSc (Hons)
Mark started his career in Pharmaceutical Discovery Research where he spent 17 years in a number of anti-infective programmes. Mark then moved into Clinical Research where he worked as a global Programme Manager working for a number of different pharmaceutical companies (British, French, American and Japanese) and has managed different trials in many therapeutic areas on a global basis. In this time Mark was involved in all aspects of research from drug development planning, management and reporting of trials and submitting trial data to authorities.
After 13 years in clinical research Mark moved to the MHRA, where he was a GCP Inspector and was involved in all aspects of GCP inspection in the UK and overseas. He was involved in the non-Commercial inspection process and also the bioequivalence inspection process. After 5 years as an inspector, Mark joined ADAMAS Consulting in October 2011 where he was involved in a number of different audit types in different areas of the world, having performed most aspects of GCP, laboratory aspects of GLP and IMP manufacturing aspects of GMP audits. In 2017, Mark moved back into the pharma industry by taking on the Senior Manager QA role at Clovis Oncology and in 2019 set up his own quality consultancy company Poulton Quality Solutions Ltd to provide global quality expertise and advice to clients to ensure compliance and understanding of clinical requirements.
He has vast experience, not only in clinical trial management but also in clinical quality compliance and training. He has conducted in excess of 350 audits / inspections of clinical trials and systems and has performed in excess of 20 training courses covering most aspects of clinical trial quality and compliance.
Qualifications
Mark has a degree in Applied Biology, specialising in Microbiology and is a member of Research Quality Assurance (RQA).
Mark Poulton
ex MHRA Inspector