Dr. Moheb M. Nasr
Director, Office of New Drug Quality Assessment, Center for Drug Evaluation and Research, FDA, USA

website:
www.fda.gov/cder/Offices/ONDQA/default.htm

Dr. Moheb Nasr is the Director of the Office of New Drug Quality Assessment (ONDQA), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). ONDQA is responsible for quality assessments (pre and post marketing) of new drugs regulated by CDER. Dr. Nasr obtained his Ph.D. degree in Chemistry at the University of Minnesota in Minneapolis. Dr. Nasr holds a B.S. degree in Pharmacy and a Master’s degree in Pharmaceutical Analysis, both from Cairo University, Egypt. After a distinguished academic career, Dr. Nasr joined the FDA in 1990, and assumed his current position in June, 2003. Dr. Nasr is leading the restructuring of the pharmaceutical quality assessment program at the FDA. Several new concepts, initiatives, and programs were developed under his leadership; including the establishment of the new Pharmaceutical Quality Assessment System (PQAS), CMC Pilot Program, CMC Regulatory Agreement, and many others. Dr. Nasr serves as the FDA lead at the International Conference on Harmonization (ICH) Q8 Expert Working Group. Dr. Nasr is a member of FDA’s Council on Pharmaceutical Quality

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