Consultant, Pharmaceutical Services

Phone: +44 (0) 1751 432 999
Country: United Kingdom

Louise Mawer has over 20 years’ experience in the pharma biotech industry, including Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP). She has seven years’ experience as an Inspector for GCP and GLP at the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Ms. Mawer was proactively engaged in the development of systems and procedures for the inspection of bioequivalence studies, advanced therapies and GCP laboratories. She has extensive experience in audits in both commercial and non-commercial settings. With a particular interest in training, Ms. Mawer has trained, mentored and coached auditors in the GLP, GCP and GVP setting.

Ms. Mawer chairs the Auditors’ Working Party for the European Forum for Good Clinical Practice (EFGCP) She has formerly served as a member of the EMA Inspectors Working Group for GCP, a MHRA GCP inspectorate representative at the Quality Risk Management Sub-group (a joint meeting at the European level between licensing assessors, clinical trials units and inspectors) and a MHRA representative at Clinical Trial Transformation Initiative meetings in Washington, DC.