Louise Mawer, Director, Mirabilitas Ltd, is a GxP quality assurance auditor and trainer, with over twenty years’ experience in GCP, GLP and, more recently, GVP. A former UK Inspector for GCP and GLP, Louise spent seven years with the MHRA, before returning to the pharmaceutical industry in 2011 and establishing her own consultancy in 2013. Louise is Chair of the Quality Working Party of the European Forum for GCP (EFGCP) and a member of the Research Quality Association Research Practice Group. Louise has presented at national and international events, and developed training for GCP, GLP and GVP stakeholders and audit groups.

Marion Mays in an industry leader in Information Management with over 25 years of experience in the Pharmaceutical industry. An advocate for essential information management practices; competent training for all contributors and consumers of the documentation which supports the advancement of clinical outcomes. Highly skilled in developing and implementing enterprise-wide programs and systems in regulated environments with proven record of success in technical problem solving. In-depth experience with quality and compliance processes in the pharmaceutical industry including supporting organizations through major regulatory inspections with FDA, MHRA, EMA, and PMDA.