Sudheendra K
Syngene Clinical Development, India
Biography
Sudheendra K has his expertise in managing the GCP Quality Management Systems at Syngene Clinical Development in the conduct of Phase I, Bioequivalence, Bioavailability studies. He has hosted many international regulatory inspections such as US FDA, EMA, ANVISA, Thailand GLP at Syngene Clinical Development. He is a trained biochemist and has been associated with GCP QMS management for the last 14+ years. He has also audited many vendors and service providers who provide support for the contract research organizations for the conduct of early phase studies. He has also audited many complex clinical trials Phase II and Phase III trials have been conducted at different hospital sites.
Abstract
Abstract : Strategy for successful regulatory inspections in a Phase I human pharmacology unit