EU Clinical Trial Regulation: New Requirements 2015

Key Topics

• Marketing Authorization Options in the EU and Linkage to Conducting Clinical Studies
• Overview of the EU and the EU Regulatory Structure
• Pertinent, Critical Articles of Regulation 536/2014
• Overview of the European Union Clinical Trial Regulation 536/2014
• The Ethics Committee
• Processes and Timelines
• Trial Protocol and Project Management
• Phases of a Clinical Trial
• Standard Operating Procedures
• Investigational Medicinal Product Dossier
• Good Clinical Practice (GCP)
• Clinical Trial Authorization Application
• Pharmacovigilance – New EU Requirements Overview
• Good Manufacturing Practice (GMP)
• Databases
• End of a Clinical Trial
• Regulatory Process
• European Union vs. The United States

Who should Attend

Clinical research professionals, project team members and associated disciplines conducting clinical studies across the European Union.