Quality by design and quality risk management
(Chinese Version)

Workshop 2

Dr. Moheb Nasr is the Director of the Offi ce of New Drug Quality Assessment, Center for Drug Evaluation and Research , Food and Drug Administration. Dr. Nasr obtained his Ph.D. degree in Chemistry at the University of Minnesota in Minneapolis. Several new concepts, initiatives, and programs were developed under his leadership; including the establishment of the new Pharmaceutical Quality Assessment System, CMC Pilot Program, CMC Regulatory Agreement, and many others. Dr. Nasr serves as the FDA lead at the International Conference on Harmonization Expert Working Group. Dr. Nasr is a member of FDA’s Council on Pharmaceutical Quality.

Dr. Paul W. Stott is Associate Director Product Development at AstraZeneca (USA) since 2006. Before this position he was Associate Director Research & Technology and Manager of the Formulation Team, Product Development (Macclesfi eld, Cheshire, UK). He held positions as Senior Scientist, Solid Formulation Development (Bristol-Myers Squibb) and Product Development (Roche Products), and as Pre-registration Pharmacist, Product Development at Wellcome. Dr Stott holds a PhD in Pharmaceutical Technology from the University of Bradford, UK.

Dr. Chi-wan Chen is Deputy Director for the Offi ce of New Drug Quality Assessment, FDA. She received her PhD degree in Organic Chemistry from the University of Wisconsin. Dr. Chen has been a technical leader in the development of FDA guidances on stability testing and botanical drug products. She represented FDA at the International Conference on Harmonization and served on the Expert Working Groups that revised the Q1A Stability Guidelines. She has been providing technical and management leadership in developing the new pharmaceutical quality assessment system in ONDQA, and is currently in charge of the FDA CMC Pilot Program.

Dr. Stephan Rönninger holds a PhD engineering degree in organic chemistry from the Technical University of Darmstadt, Germany (1990) and performed a post doctoral studies at the University of Zurich, Switzerland. He has been with Roche since 1992 leading a preparative and analytical laboratory, in project management, as production manager, in Quality Assurance and in Quality management. In April 2003 he joined the Global Quality Department in Pharma Global Technical Operations. In this function his main focus is on external relations and maintains the global Pharmaceutical Manufacturing Standards (PMS) of Roche.

Mr. Jacques Morénas is a civil servant as « pharmacien général de santé publique » and belonging to the pharmacist-inspector profession. He is graduate as a pharmacist from the faculty of pharmacy, University of Clermont-Ferrand. He received his pharmacist inspector degree from the National School for Public Health. He is assistant director of the Inspection and Companies department in the French Health Products Safety Agency, in Saint Denis (France). He is in charge of international affairs (in the fi eld of good manufacturing practice), quality assurance (for the Inspection and Companies department) and training (for the inspectors of the French Agency).