Clinical Trial Applications in Canada, and Comparison to US and EU 2014

Key Topics

• Inspections and Q & A
• Clinical Trial Groups
• Research Ethics Boards
• Overview of Health Canada
• Special Considerations for Biologics
• Regulatory Basis for Oversight of Clinical Trials
• Special Considerations for Use of Devices in Clinical Trials
• Amendments to Protocols and Supplies
• Special Considerations for Gene Therapy
• Good Clinical Practice
• Phase IV Clinical Trials
• Filing a CTA in Canada
• Pharmacovigilance in Clinical Trials

Who should Attend

• Regulatory Affairs Managers
• Director of Regulatory Affairs
• Regulatory Affairs Associate
• Coordinator of Regulatory Affairs
• Clinical Manager
• Clinical Research Associate
• Pharmacovigilance Manager for Clinical Trials
• Director of Product Development
• R&D Managers and Directors