Clinical Trial Regulatory & Guideline Requirements 2013

Topics

• Decipher the Framework of Clinical Trial Regulations and Guidelines in Europe
• Update on the proposed changes to the Clinical Trial Directive
• Gain an Overview of the EU Clinical Trial Directive and GCP Directive and some of the Key issues
• Discuss the Clinical Trial Directive Process for Overcoming the Problems of the Directive (2011 consultation)
• What are the Implications of Running Clinical Trials in Children: The Paediatric Plan and Ethical Considerations
• Understand Clinical Trials Authorisations: Regulatory Approval and Ethical Approval
• Understand the Legal Aspects of Clinical Trials