Michael Edwards

Michael has over eighteen years of experience in pharmaceutical regulatory affairs, with a career spanning both the regulatory authority sector – specifically the United Kingdom (UK) Medicines Control Agency – and the pharmaceutical industry.

His regulatory and peri-registration experience has focused primarily on human medicinal products. He has worked across national procedures (both within and outside the European Union) and European regulatory frameworks. His areas of expertise include orphan drug designations, paediatric investigation plans, clinical trial authorisations and their maintenance, pre-submission activities, marketing authorisation applications, and lifecycle maintenance of approved products. Additionally, Michael has some experience with regulatory activities related to veterinary medicinal products.

Michael began his career at the UK national medicines regulatory authority before moving into roles within regulatory consultancies and pharmaceutical companies. He has also worked as an independent regulatory consultant, contributing to a wide range of regulatory projects.

He holds a degree in Pharmacology with Toxicology and completed a doctoral thesis focused on the vascular bioactivity of phenolic phytochemicals – specifically anthocyanins and their in vivo degradation products or metabolites – studied in vitro.