Trial Master File (TMF) Summit

The Trial Master File (TMF) Summit is dedicated to best practices of developing and maintaining a compliant Trial Master File (TMF) both in electronic and paper format, as a proof that good clinical practices (GCP) is being held during the trial.

Key Topics

• How to develop and enhance your TMF process and structure to meet technology, business and regulatory needs
• An inspector’s expectation of TMF accessibility and availability
• Enhancing the collection of eISF and managing internal and external email correspondence
• Case study presentations

Who should Attend

Attendees from pharmaceutical, biotech, medical device and clinical research companies with responsibilities in:

• 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

and also:

• Data/Records Management Vendors
• ETMF Service Providers
• Paper and Electronic Archiving Solution Providers
• Clinical Research Organizations