Clinical Trial Regulatory Guideline Requirements 2016

Key Topics

• The New EU Clinical Trial Regulation and How this will Replace the EU Clinical Trials Directive in 2016
• Understand the Current Framework of Clinical Trial Regulations in Europe
• Ethics Committee (EC) Submissions and Approval
• Clinical Trials Authorisation: Regulatory Approval and Ethical Approval
• Brief Overview of Legal Aspects of Clinical Trials
• Running Clinical Trials in Children: The Paediatric Plan and Ethical Considerations
• Pharmacovigilance and Adverse Event Reporting
• Investigational Medicinal Product
• Brief Considerations for Preparing for Regulatory Inspection
• Brief Overview of other Recent EU and FDA Developments in Clinical Trial Requirements including:

Who should Attend

• Clinical research
• Working in regulatory
• Project management
• Clinical operations
• Vendor/CRO professionals
• Quality assurance (GCP auditors)