This two-day training course will be of great benefit to clinical research professionals conducting clinical studies in the European Union either as stand-alone trials or as part of a multi-national clinical study program. Upon completion of this course, participants will have a working knowledge of the EU Clinical Trial Directive requirements including: The latest information regarding the interpretation and enforcement of these regulations; an understanding of how to implement and be compliant with the Directive; and a grasp of how the EU Clinical Trial Directive differs from the US FDA Regulations and ICH Guidelines.