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Session 9 Track 3: NextGEN TMF Management Panel– Data is the Key
Session Chair(s)
Karen McCarthy Schau
Director, Risk-based Study Management
Vertex Pharmaceuticals, United States
Our panel of TMF experts share their vision of successfully managing your TMF in the age of data and what it takes to survive and thrive in an inspection. From hearing about how using a Risk-Based approach to efficiently manage your key content and minimize the inspection scramble, to using Machine Learning for document identification and filing, your TMF process will benefit from the hard-won knowledge and experience of the panel.
Learning Objective : At the conclusion of this session, participants should be able to:
- Learn the best practices for preparing for an upcoming inspection
- Discuss the key components of effective risk-based QC and QR: identification of critical process and critical data; identification and assessment of risks; risk control; and risk communication, review and reporting
- Identify TMF management problems that machine learning (ML) can help solve today
Speaker(s)
How Risk-based Quality Control in a Trial Master File Improves Quality While Reducing Effort
Marion Mays
Jerion Consulting, United States
CEO / Consultant
Machine Learning and TMF Management: Evolving to Data-Driven Processes
Ken Keefer, MBA, PMP
Keefer Consulting Inc Visa, United States
Principle Consultant
Leveraging Technology for Preparing for and Surviving Remote TMF Inspections
Paul Fenton, MBA
Montrium, Canada
CEO