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.

Sameera T., Senior Specialist, is a GxP quality assurance auditor and trainer at Janssen Research & Development of Johnson & Johnson companies. She has over 13 years’ experience within the pharmaceutical industry working in Clinical Operations, Quality Assurance and Training. She has experience in Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP). Sameera is currently leading the Research Quality Association (RQA) Volunteer Program and was a core member of the RQA Education & Training Committee.