Robert E. Zoubek
GRC&S, Germany
Biography
Dr. Robert E. Zoubek is an expert in biosimilar development, manufacturing, and analytics as well as regulatory affairs. Until he joined European′s leading Consultancy Company GRC&S, he worked in several positions at Formycon (Germany) and GlycoForm (UK). As Director Scientific Affairs Robert led Formycon′s drug product development and analytical services. A focus of Formycon was its Biosimilar portfolio. In other roles he was responsible on the CMC activities of the Novel Biologics programs and led the GMP-certified Quality Control laboratories. Robert earned a PhD from the University of Erlangen-Nuremberg for his research on wound-healing peptides and he was awarded MBA from the University of Manchester. He also holds a MSc from the University of Munich. Today Robert is involved in a number of projects throughout different development stages, from early development up to marketing authorization and post-approval activities. His profound CMC knowledge and development experience make him a valuable partner for the success of projects.
Abstract
Abstract : Analytical strategies for the Marketing Approval in highly regulated markets