Speakers

Dr. Rapti Madurawe is a Division Director in the Office of Pharmaceutical Quality Assessment III at FDA. She has broad regulatory experience in the CMC review of drug and biologics applications in CDER. Dr. Madurawe is the co-chair of the CDER Emerging Technology Program, a member of the FDA Advanced Manufacturing Technologies Working Group, and the FDA topic lead for the ICH Q13 guidance on continuous manufacturing. She holds a Ph.D. and a bachelor’s degree in chemical engineering, as well as a Master of Science degree in biochemistry. Prior to joining the FDA, Dr. Madurawe worked in the biotech and biopharmaceutical industries as a process development engineer.