Dr. Owen Lewellen (PhD, BSc, C.Chem, FRSC, FTOPRA) graduated from St Andrews University, Fife, Scotland, with a degree in Biochemistry, and obtained his doctorate through research in the field of drug metabolism and pharmacokinetics. He is CEO of EU Vigilance Ltd and heads our office in UK. He is experienced in a wide range of healthcare products´ regulatory affairs and vigilance. His further affiliation is Charisbert Consultancy Ltd.
He has more than 22 years experience as a Regulatory Affairs Professional, gained at the Paris-based European Headquarters of a major multinational pharmaceutical company and then as an independent consultant.
His regulatory experience covers early drug development through to post marketing (regulatory maintenance, life-cycle management, advertising and promotion), and prior to this, his experiences included project management, Pharmaceutical Technology Development / Industrial Operations, as well as Biochemical Research, and Drug Metabolism and Pharmacokinetics.
He served for many years as Board member and Director of TOPRA (The Organization for Professionals in Regulatory Affairs) and is also a member of PIPA (Pharmaceutical Information and Pharmacovigilance Association).
Dr. Lewellen has published numerous scientific articles and publications since 1970. You can find a selection of them in our Reading section.