Conducting EU Studies from a US Virtual Biotech Company 2012

Key Topics

• European regulations for submitting expedited and periodic safety reports
• Applicable European Regulations for Initiating and conducting clinical studies in the EU
• Regulations (and necessary infrastructure) for importing the test and comparison articles and other clinical supplies in the EU
• Clinical material requirements
• Filing requirements in individual states
• Insurance requirements
• Transport and testing of tissue samples
• Monitoring of clinical trials in the EU
• The role of Institutional and regional Ethics Committees in the EU

Who should Attend

• QA Directors/Managers/Associates
• Senior Management in Operations
• Clinical Research Associates and Coordinators
• Clinical Project Directors and/or Managers
• Regulatory Affairs Managers and Associates