M. Anne Openshaw, BSc, DPhil, FTOPRA

M. Anne Openshaw, BSc, DPhil, FTOPRA, Associate Consultant, Phoenix^SM representative in Europe, has gained extensive regulatory experience during many years of independent consultancy. Her clients have included large numbers of multinational, generic and specialist companies, and projects undertaken have ranged from preparation of clinical trials and marketing authorization applications to briefing documents for regulatory agencies, and wide-ranging regulatory advice and strategy. Approximately half the projects have involved new active substances, including synthetic chemicals, biologicals, biotechnology and other specialized products plus new formulations and generic products. Therapeutic areas include GI, cardiovascular, CNS, inflammatory diseases, oral contraception, HRT, bone conditions, skin conditions, anti-infective, anticancer, HIV/AIDS. Formerly, she was employed by Smith, Kline and French in regulatory positions with responsibilities for UK, R&D and international regulatory projects. Dr. Openshaw has a BSc in Applied Biology and a DPhil in Bacterial Mutagenesis and is a Fellow of TOPRA (The Organisation for Professionals in Regulatory Affairs). She is an active member of the Postgraduate Faculty of TOPRA, and has contributed extensively to developing, managing and examining the established TOPRA/University of Wales MSc course in Regulatory Affairs.