Michael Edwards

Michael has over seventeen years’ experience in pharmaceutical regulatory affairs, with employment in both regulatory authority [United Kingdom (UK) Medicines Control Agency (MCA)] and industry sectors.

Michael’s previous experience with regulatory and peri-registration activities includes work primarily on human medicinal products, using national – both within and outside the European Union – and European procedures, including orphan drug designations, paediatric investigation plans, clinical trial authorisation and maintenance, pre-submission activities for marketing authorisation, and marketing authorisation application and maintenance; and some experience with veterinary medicinal products.

Michael initially joined the UK national medicines regulatory authority but has since worked as part of regulatory consultancies and pharmaceutical companies, and also as an independent consultant.

Michael holds a degree in Pharmacology with Toxicology; and has completed a doctoral thesis investigating the vascular bioactivity in vitro of the phenolic phytochemicals anthocyanins, and their in vivo degradation products or metabolites.