Speakers

Dr. Niles Ron is currently a Supervisory Pharmaceutical Scientist in the Division of Product Quality Assessment X (DPQA-X) within the Office of Product Quality Assessment II (OPQA-II)/Office of Pharmaceutical Quality (OPQ). Dr. Ron has been with the FDA since January 2011, where he oversees the assessment and regulation of pharmaceutical quality in drug products. Prior to joining the FDA, he held several positions of increasing responsibility in scientific management in the biopharmaceutical industry over a 13-year period, focusing on chemistry, manufacturing, and controls (CMC) activities, including formulation, product and process development, and manufacturing. He received his PhD in Chemical Engineering from Washington University in Saint Louis (St. Louis, Missouri) and his MBA from Clark University (Worcester, Massachusetts).