Regulatory Submissions, Information, and Document Management Forum

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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

Kivo, Inc, United States

Senior Vice President of Clinical

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

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