Sheila Macrae

Sheila Macrae has been an independent consultant for more than ten years, specialising in toxicology and risk assessment for product safety and environmental pollution, assisting contract research organisations, chemical, pharmaceutical and agrochemical companies. She founded Macrae Consultancy following 20 years in the pharmaceutical and contract research industry specialising in the planning, management and conduct of toxicology studies, project management and five years of consultancy work while based in Italy. Sheila is also an experienced GLP and Quality Assurance consultant and auditor/inspector with more than ten years experience of design of facilities for compliance with GLP since 1987, when she founded CMC International with a colleague to assist a number of Italian pharmaceutical companies to gain GLP accreditation and operate in GLP. Since then she has assisted contract research organisations, chemical, pharmaceutical agrochemical companies, independent analytical laboratories and specialist independent researchers (pathologists and genetic toxicologists) to maintain GLP accreditation under the GLP monitoring scheme and acts as a GLP co-ordinator, independent auditor and/or inspector providing a complete GLP QA service.

Sheila trained at the Universities of Glasgow, Strathclyde and East London (M.Sc. in Pharmacology and Toxicology) and is a member of the Institute of Biology (Thesis on Gastric Secretion in the Rat). She is a Chartered Biologist and Registered Toxicologist and is a member of the Institute of Biology, the British Toxicology Society and Eurotox. She is the principal author of many unpublished reports on Toxicology studies submitted to International Regulatory Authorities including, the MHRA, FDA, EPA, JMAFF and the JMHW and has been responsible for or involved in the preparation of Common Technical Documents in support of Marketing Applications for chemicals, pharmaceuticals and agrochemicals in Europe. She is a member of the British Association of Research Quality Assurance.