INTRODUCTION This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with GCP as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP. The meeting will address a typical case study where a practical approach will be made to setting up, running and monitoring clinical trials followed by an audit of these studies to satisfy the stringent requirements seen in Europe. Standard documentation utilised for recording data, performing audits and a typical protocol will be supplied for use in the delegates’ company own laboratories.