Dr Louise Bisset is an Expert Quality assessor at the MHRA, the competent authority for medicines regulation in the UK (2008-present). Aside from wide experience in the regulation of all types of biological medicinal products, Dr Bisset has specialist expertise in the regulation of ATMP’s.
During her 15 + years as a regulator of ATMPs, Louise has acted as Rapporteur for several new products and provided input to many other EU-licensed ATMPs, in addition to providing scientific and classification advice nationally and on behalf of the European Medicines Agency (EMA).
Dr Bisset was a member of EMA’s Cell-Products Working Party and Biologics Working Party and a member of EDQM’s Working Party for the development of the European Pharmacopoeia monograph on raw materials for the production of cell-based and gene therapy medicinal products and has contributing to many other official regulatory guidance documents and publications.
Prior to joining the MHRA, Dr Bisset held several group leader positions in cell-based and bio-analytical assay development for early-stage drug-discovery within the biotech sector.
Louise has a PhD in Biochemistry.
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