Asia-Pac Trial Master File Summit 2016

The Asia-Pac Trial Master File Summit 2016 is dedicated to Efficiently manage, develop and create a compliant TMF structure for PMDA and global inspections.

Key Topics

• Documents vital to a successful TMF
• TMF requirements and filing processes
• How an eTMF system can increase quality
• The implementation and utilization of TMF metrics
• Inspection preparation strategies for paper and electronic document systems
• ETMF vendor selection
• What to do when regulatory authorities are asking for eTMF access
• TMF milestones and SOPs to ensure timely document submission

Who should Attend

• Clinical Document/Data Management
• TMF and eTMF Management
• Clinical Operations
• Clinical Trial Administration
• Trial, Document and Record Management
• Regulatory Affairs/Operations
• Clinical Development/Study Management
• Clinical Document Coordination
• Competency Development
• Quality Assurance/Control/Operations
• Quality Management
• Strategic Operations and Planning
• Clinical IT
• Informatics