Louise is a quality assurance auditor and trainer with extensive experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and, more recently, Good Pharmacovigilance Practice (GVP). She studied at Leicester Polytechnic (Science of Medicinal & Cosmetic products) and The Open University (BSc Honours).
Working initially in inhalation formulations research and development, Louise moved into Quality Assurance in 1995, where she was employed by a UK Phase I unit with responsibility for overseeing Study GCP compliance. She left Leicester to move to Harrogate, North Yorkshire, and a large Contract Research Organisation, working in the field of GLP.
Following 10 years as an auditor, Louise joined the UK Medicines and Healthcare Products Regulatory Agency (MHRA), as a GCP Inspector where she cross-trained as a GLP Monitoring Authority (GLPMA) Inspector.
An active participant at the European Medicines Agency (EMA) GCP Inspectors Working Group, Louise supported the development of guidance on risk-adapted clinical trial methodologies, bioequivalence and clinical laboratory inspections, and GCP for Advanced Therapy Medicinal Products. Louise also participated in joint working with US FDA Investigators for GCP and contributed to Clinical Trial Transformation Initiative meetings.
She currently provides Quality Assurance and training support to those involved in pharmaceutical development, including pharmaceutical companies, biotech companies and those in the non-commercial sector. She is the Chair of the Auditors’ Working Party for the European Forum for GCP and is a member of The Research Quality Association, supporting both the Northern Regional Forum and the Research Practice Group.
Events/Masterclasses Louise Mawer is currently speaking at
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