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Regulatory Submissions, Information, and Document Management Forum
Session 9 Track 3: NextGEN TMF Management Panel– Data is the Key
Karen McCarthy Schau
- Director, Global Clinical Operations
- 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 : After attending the presentation, participants will be able to: 1. Identify TMF management problems that machine learning (ML) can help solve today. 2. State how the TMF Exchange Mechanism Standard could extend current ML capabilities. 3. Recognize how greater metadata standardization and ML could benefit TMF management industry-wide.
How Risk-based Quality Control in a Trial Master File Improves Quality While Reducing Effort
- VP, BD Expert Solutions and Consulting
- Phlexglobal Inc, United States
Machine Learning and TMF Management: Evolving to Data-Driven Processes
Ken Keefer, MBA, PMP
- Principle Consultant
- Keefer Consulting Inc, United States
Leveraging Technology for Preparing for and Surviving Remote TMF Inspections
Paul Fenton, MBA
- Montrium, Canada