Ramnarayan Randad
Food and Drug Administration, USA
Biography
R. S. Randad, Ph.D. (Ram) is Quality Assurance Leader and Master Review Chemist in the office of Life Cycle API, ONDP. In addition to the CMC reviews, he has served on number of working group such as Risk-Based Review, Complex Drug Substance, Question based Review (QbR), Quality by Design based QbR revision, the Office of Generic drugs Education and Training committee, DMF Completeness assessment team, Center for Science and advancement, and US Pharmacopeia monograph development committees. He has frequently represented Agency on CMC issues and regulatory science in public speaking engagements. He is an author of “FDA Drug Review and Regulation” to the “Burger's Medicinal Chemistry, Drug Discovery and Development”.
Prior to joining FDA, Ram worked in the private sector for 15 years as a Research Chemist, Principal Investigator, Group Leader, and Director of Chemistry. Randad has authored more than 25 scientific papers in the peer reviewed journals and has > 10 US patents to his credit. His work has led to the design and development of a drug lead. He received Ph.D. from National Chemical laboatory, Poona University, India in 1985. Soon after, he came to US as a Postdoctoral Associate of Prof. Herbert C Brown, Nobel Laureate, Purdue University.
Abstract
Abstract : Regulatory requirements and filling considerations for type II master files