Clinical Trial Guidelines & the New Clinical Trial Regulation 2015

Clinical Trial Guidelines & the New Clinical Trial Regulation 2015 is a conference dedicated to the Current EU Clinical Trial Requirements.

Key Topics

• New Clinical Trial Transparency Requirements in the EU
• New Clinical Trial Regulation in the EU
• The Current EU Clinical Trial Requirements
• The Framework of Clinical Trial Regulations and Guidelines in Europe
• Running Clinical Trials in Children: The Paediatric Plan and Ethical Considerations
• Clinical Trial Authorisations: Regulatory Approval and Ethical Approval
• Ensure you Comply with Pharmacovigilance & Adverse Event Reporting
• The most Important Legal Aspects of Clinical Trials
• FDA requirements including Recent Development
• Clinical Trial Data Management
• What you need to know about Regulatory Inspections