Day 2 Session 4 - 4ward Thinking Experts Take on V4 of the TMF Reference Model скачать в хорошем качестве

Day 2 Session 4 - 4ward Thinking Experts Take on V4 of the TMF Reference Model

Big changes are coming to the TMF Reference Model—and this panel will give you a front-row seat. Join leading experts as they discuss the ongoing work to evolve the model into a formal digital TMF standard and what this transformation means for the future of clinical trial documentation. With Version 4 scheduled for release in Q1 2027, the panelists will explore the key updates, strategic goals, and anticipated benefits for TMF professionals. From greater interoperability to improved digital alignment, this conversation will highlight how V4 aims to reshape TMF management for the better. What you'll learn: What to expect from Version 4 of the TMF Reference Model How the model is evolving into a formal digital standard Advantages V4 will bring to TMF professionals and clinical operations Key changes in development and why they matter How to prepare your organization for this upcoming transformation CHAPTERS 00:00 Introduction 01:43 Speakers introduction 03:02 What can we expect to be part of V4 09:44 Alignment with the broader digital transformation and big impacts 15:15 How is it going to impact processes and TMF Oversight? 19:04 Is v4 designed to be more adaptable to regulatory shifts? 26:48 What does it mean to be a standard? 27:04 From subartifacts to record types in V4, will companies still have the ability to customize based on business needs? 30:15 How can organizations start to prepare for V4? 35:40 What to consider before to transition from TMF RM V3 to V4 with ongoing trials 37:15 What role should change management and training play for a succesfull transition 42:40 Making the TMF TM a standard and talking to the regulators 44:45 What will V4 improve for the future? 45:41 Closing words and next session introduction