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.
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
