USA and EU regulatory submissions for veterinary medicines

3^rd International Conference on Pharmaceutical Regulatory Affairs

October 21-23, 2013 DoubleTree by Hilton Hotel San Francisco Airport, CA, USA

Karolina Bate

Scientific Tracks Abstracts: Pharmaceut Reg Affairs

Abstract :

The USA and the EU are the 2 major animal health markets in the world. A combined USA/EU drug development approach allows pharmaceutical companies to co-ordinate resources, shorten development times, promote financial efficiency and ultimately expand revenue. However, a combined approach faces many challenges, as both the USA and EU have significantly different regulatory frameworks, timeframes and requirements. In such a highly regulated industry, knowledge of both USA and EU regulatory requirements, procedure, policy and standards is crucial in order to conduct joint USA/EU programs of development, prepare dossiers for submission and obtain marketing authorizations in both territories. This presentation will describe the similarities and differences between the USA and EU requirements for obtaining a marketing authorization for a veterinary medicinal Product.

Biography :

Karolina Bate has a Bachelor?s Degree in Pharmacology and a Ph.D. in Immunology from the University of Wales, Cardiff. She jointed Cyton Biosciences Ltd in 2007 and currently holds the position of Projects Director. Cyton Biosciences Ltd is a regulatory consultancy based in the UK, which is part of the global Knoell Group.