9th Trial Master File Summit - US

Topics

• Implement and utilize TMF metrics
• Increase quality by implementing QC
• Select when and where to use a CRO’s eTMF instead of an internal system
• Develop TMF milestones and SOPs to ensure timely document submission
• Meet training and staffing needs for a TMF
• Establish an eTMF system to increase quality
• Prepare for when regulatory authorities ask for eTMF access
• Improve clinical operations in TMF management

Who should Attend

• Document Management
• Clinical Operations
• TMF and eTMF
• Regulatory Affairs
• Clinical Document Coordination
• Data Management
• Clinical Development
• Document and Record Specializations
• Essential Document Management
• Regulatory Operations
• Knowledge Management
• Quality Assurance and Operations
• Strategic Clinical Operations and Planning
• Global Planning and Standards
• Quality Management
• Clinical Trial Management
• Clinical Information Technology
• Informatics