Louise Mawer, Director, Mirabilitas Ltd, is a GxP quality assurance auditor and trainer, with over 20 years’ experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and, more recently, Good Pharmacovigilance Practice (GVP).
Travelling extensively worldwide, Louise provides coaching, mentoring, training and audit/quality system support to both pharmaceutical companies and academic researchers.
A former Medicines and Healthcare products Regulatory Agency (MHRA) Inspector for GCP and GLP, she returned to the pharmaceutical industry in 2011 before establishing her own consultancy in December 2013.
With wide and varied interests, Louise has advised on data integrity issues, worked in academia developing data management quality systems, performed For Cause reviews in a variety of settings (clinical laboratories, GLP laboratories, Investigator Sites and Contract Research/Academic Research Organisations), and supported process development/gap analyses with or without ‘the imminent Inspection’ driver.
A proponent of pragmatism, the risk-based approach and simplification, Louise thrives on the challenges facing start-up biotech and academic researchers, and global organisations, seeking innovative compliant solutions to today’s drug research environment.
Renowned for her personable presentation style, and informative, accessible content, Louise has presented at national and international events, and developed training for GCP, GLP and more recently GVP stakeholders and audit groups.
Lively, outgoing, enthusiastic and colourful, she is Board member for Strategy of The Research Quality Association and confirmed member of Pottermore.