Qualified Person under EU Directives

Malcolm E. Brown is an award-winning writer with over 180 publications who writes columns and blogs (with ISSNs) in journals and magazines. He writes across diverse fields, including scientific papers, fiction, art, astronomy, philosophy, AI and the sociological interpretation of worlds. He holds a BA (Open University), a master's degree (University of Bradford), and a doctorate (University of East Anglia) in natural and social science research. He was elected (2021) a Fellow of the Royal Pharmaceutical Society (FRPharmS) for distinction in the pharmacy profession. He has worked in senior positions as a production manager (big Pharma) and in the British NHS, including at director level and as a community pharmacist. He has tutored many future pharmacists and trained a major international company's “entire” sales force on selling medicines to the NHS. He has certified batches of medicine as a Qualified Person (QP) in accordance with EU regulations. One speciality was the micronisation of active pharmaceutical ingredients (APIs). Several licences for human, veterinary, and investigational medicinal products (clinical trials) named him. Pharmaceutical forms included lyophilised injections, tablets, solutions, and medical gases. He has audited and advised in several countries. He was the keynote speaker at an international multidisciplinary conference at The Hague. He is an honorary careers mentor at the University of East Anglia (UEA).