Introduction to Clinical Trials and GCP EU and US Clinical Trials Regulations Compared QA and GMP for Clinical Trials Manufacture The Application of QA and GMP to the Manufacture and Supply of Investigational Medicinal Products EU Directive 2001/20/EC and its impact on the Manufacture of Clinical Trial Supplies GMP for API’s for Clinical Trial Use GMP for the Manufacture of Investigational Medicinal Products GMP for the Packaging of Investigational Medicinal Products Investigational Medicinal Products : The Role of the Qualified Person