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.
The Asia-Pac Trial Master File Summit 2016 covers topics such as:
- 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
The Asia-Pac Trial Master File Summit 2016 brings together:
- 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
