Day 4 Session 4 - Leaders Share Their Practical Applications of Risk Based Approaches скачать в хорошем качестве

Day 4 Session 4 - Leaders Share Their Practical Applications of Risk Based Approaches

When it comes to applying a risk-based approach to TMF management, there’s no one-size-fits-all formula. In this panel discussion, industry experts will explore the key ingredients of a proportional and effective strategy—sharing lessons learned from real-world implementations and the pitfalls to avoid. From frameworks that hit the mark to those that missed the mark, panelists will offer a candid look at what works, what doesn’t, and how to tailor your risk-based oversight model to your organization's needs. If you're looking to refine or reimagine your own approach, this session will offer both inspiration and practical guidance. What you'll learn: Core elements of an effective risk-based TMF oversight strategy Examples of successful and unsuccessful implementation frameworks How to tailor a risk-based approach to your organization's size, scope, and risk profile Insights from panelists with firsthand experience across various TMF environments CHAPTERS: 00:00 – Welcome and Housekeeping 02:43 – Panel Introductions 05:15 – What Is a Calculated Risk? 08:58 – Industry Perspectives: Risk and Burden 14:14 – TMF Risk Within Broader Trial Risk 16:05 – TMF Risk-Based Monitoring in Practice 17:18 – Risk-Based Thinking Challenges in Smaller Companies 19:34 – Why Embrace a Risk-Based Strategy? 23:06 – Do We Really Need That File? 29:43 – Where Risk-Based TMF Has Been Applied 33:42 – The Power of Stakeholder Accountability 35:17 – Addressing Blind Spots in TMF Oversight 36:28 – Building a Structured Oversight Model 39:22 – Risk Scores Must Evolve Over Time 40:14 – Future of Risk-Based TMF: Process-Level Scoring 42:07 – Where to Document Risk-Based Approaches 44:42 – TMF Plans vs. SOPs: One Size or Custom? 46:44 – Are Your Systems Helping You Apply Risk? 50:01 – The Need for Better TMF Tools 51:18 – The Case for Living Documents 53:58 – Interoperability and the Future of TMF 57:16 – Looking Ahead: What’s Next for TMF Risk 59:19 – TMF for Value, Not Just Compliance 01:01:13 – Final Words and What’s Next