International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective

Dr. Pierre-Louis Lezotre specializes in global regulatory strategy, and is recognized for his passion and expertise on international cooperation, convergence, and harmonization of regulations for pharmaceutical and biotechnology products. He has worked in different cultural environments and lived in both Europe and the United States. Dr. Lezotre studied biology (University of Sciences, Saint-Etienne, France) and drug development (University of Pharmacy, Montpellier, France) from 1992 to 1998. He then received his Master in Regulatory Sciences in 1999 (University of Pharmacy, Lille, France). He also recently completed his PhD in Law with honors (Doctoral School of "Law, Politics and Management, University of Law, Lille, France). Since 1998, Dr. Lezotre has worked for several international pharmaceutical and biotechnology companies, with increasing levels of responsibility. He has served as a regional and then global regulatory leader for small molecule and biologic/biotech programs in various stages of research and development (from early discovery to life cycle management). He successfully led many global regulatory teams in supporting global registrations of major products and numerous development projects in several therapeutic areas, including dermatology, urology, neurology, and pain. He has been responsible for communications with worldwide Drug Regulatory Authorities and has also worked with external partners/ companies through co-development agreements and business development programs. Dr. Lezotre has recently been invited to teach courses on international regulation in the Regulatory Sciences programs of the University of Southern California (USC).