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Join Gillian Gittens and Guoqing Yang for a practical session on TMF oversight in the era of ICH E6(R3). Learn how to meet rising regulatory expectations while maintaining quality, consistency, and inspection readiness across your TMF.
They break down how global guidance from FDA, MHRA, PMDA, and TGA translates into day-to-day TMF practices, and share proven approaches to building and refining oversight frameworks that hold up under inspection. From sponsor–CRO alignment to the role of technology in sustaining compliance, this session focuses on what actually works in practice. Smarter oversight leads to stronger quality and audit-ready TMFs.
You will learn:
- How ICH E6(R3) reshapes expectations for TMF oversight and compliance
- How to design and implement a scalable TMF oversight framework
- What regulators expect to see in an inspection-ready eTMF
- How sponsors and CROs can align roles, responsibilities, and accountability
- How technology supports sustainable TMF quality and control
- How to identify and close gaps before they become inspection findings