- Theme #1 - R3, Risk, and the Road Ahead for TMF Management
ICH E6(R3) is reshaping TMF oversight and sponsor accountability. Risk-based approaches are now expected, and execution is under scrutiny. Sponsors, CROs, and inspectors are redefining what effective oversight looks like.
This theme will help attendees understand how to structure oversight models, apply risk-proportionate approaches, and prepare for inspections under R3.
Topics to consider (but not limited to):
• The new rules of TMF oversight under R3
• Real-world applications of risk-proportionate approaches
• Risk-based quality management and its intersection with TMF oversight
• The evolving sponsor oversight model in a risk-based, remote world
• Lessons from recent inspections in a post-R3 environment
Theme #2 - Keeping Pace with Digital Transformation and Standardization
Trials are becoming more complex and decentralized. Standardization, system alignment, and data governance are now inspection priorities. Inconsistent records, weak metadata, and unclear data ownership are common findings.
This theme will help attendees define data and records standards, align IT, clinical operations, and quality, and prepare for the shift to the TMF Standard.
Topics to consider (but not limited to):
• What “digital TMF” means in practice versus perception
• The shift to structured data models, including ICH M11 and Digital Data Flow
• The standardization of records data
• Data integrity challenges in decentralized trials
• Cross-functional alignment across IT, clinical ops, and quality
• The shift from the TMF Reference Model to the TMF Standard
• The role of metadata and taxonomy in driving standardization
Theme #3 - The AI Era and the Governance Imperative
AI adoption is accelerating faster than regulatory guidance. Governance gaps create operational and compliance risk. Organizations are testing AI, but oversight models are still forming.
This theme will help attendees understand how to govern AI use in TMF operations, validate tools, and build oversight frameworks. Panelists may share their AI experiments, governance frameworks, what has been working, and what has not.
Topics to consider (but not limited to):
• AI applications in TMF management (risks, challenges, successes)
• Upskilling the TMF professional for AI-augmented future (new skills and mindsets)
• Validation of AI tools in regulated environments
• Human-in-the-loop models for AI oversight
• Scaling AI responsibility in TMF operations
• Governance frameworks and AI guardrails in practice
• Navigating today's AI guidances and regulations (EMA, FDA)
• Understanding how inspectors assess current AI use in TMF
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