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Global Engagement Team Biographies

Tim Stiles (Chair)

Tim is a Director of Qualogy Ltd, a global consultancy support organisation which provides consultancy on implementation, training, advice, audit and contract regulatory archive services to those working in the GLP, GCP, GCLP and GMP industries.
He has worked within the regulatory arena for over thirty years. Prior to establishing Qualogy Ltd he was the Director of Quality Assurance within a large Contract Research Organisation (CRO) where he had total responsibility for the Regulatory Compliance Programme and regulatory archive worldwide.
Tim was a member of the International Expert Group within The Organisation for Economic Co-operation and Development (OECD), which worked on the 1997 revision of their principles of Good Laboratory Practice.
He is past Chairman of The British Association of Research Quality Assurance (BARQA) and has been pro-active with Governments and Industry to develop and enhance the Quality Assurance Profession.
He is a fellow of the Research Quality Association and has been a member of numerous RQA (BARQA) committees, working parties and most recently a member of their Clinical Committee.
Tim was involved in the inception of RQA QA professional development course programme within the UK and has lectured widely throughout the world on numerous regulatory compliance issues.
As a recognised training professional he has organised and presented training courses around the world on various GCLP, GLP and GCP topics.
He was also been the principle author of the recently published Scientific Archivists Group (SAG) guidance for the archiving of electronic regulatory records.
GCLP

Tim chaired the independent group that produced the global Good Clinical Laboratory Practice (GCLP) guidance for laboratories on the regulatory expectation for laboratories that analyse samples from clinical trials.
Subsequent to publishing GCLP through RQA (BARQA) he has established the GCLP Accreditation scheme. This global GCLP Accreditation scheme, which is growing rapidly, has accredited over 40 laboratories around the world to the GCLP standard.

 

Kerry Bunyan (Secretary)

Kerry is the QA Manager at TMQA and has experience performing pre-clinical and clinical audits in most European countries and provides support to companies developing a quality management system. Kerry has an academic background including post-doctoral research before joining the QA unit at Charles River Laboratories in 2004.

 

Shirley Hallam

Shirley has worked in clinical research and development within the pharmaceutical industry since 1990, for pharmaceutical companies, CROs and non-commercial sponsors. She has conducted various GCP audits in most European countries and the USA. Shirley advises on clinical quality management systems, is an experienced trainer and undertakes medical writting assignments. Shirley holds the Institute of Clinical Research post-graduate diploma in Clinical Research and the RQA certificate of Quality Management.

Patricia Henley

Patricia is the Clinical Trials Manager at the London School of Hygiene & Tropical Medicine. Patricia is a biology graduate and holds an MSc in Environmental Services. Previous appointments include a Clinical Dta Manager at the Institute of Child Health, based at the Great Ormond Street Hospital, London, Clinical Trials Coordinator for Cancer Research UK and the UCL Trials Centre and Research Facilitator for the Clinical Research Governance Office at Imperial College.

Gail Holland