As ICH E6(R3) reshapes the clinical trial landscape, sponsors and CROs alike are navigating heightened expectations around Trial Master File oversight, quality, and inspection readiness.
In this webinar, Trial Interactive's Senior Director of e-Clinical Strategy and CDISC TMF Reference Model Steering Committee member, Gillian Gittens, will walk attendees through the latest regulatory developments, including guidance from the FDA, MHRA, PMDA, and TGA, and what E6R3 means in practice for TMF management and compliance.
Joining the discussion is Guoqing Yang, Sr. Clinical QA Director at Henlius Biotech, who will offer a firsthand look at how Henlius has built and refined its TMF oversight framework to meet evolving global regulatory standards. Together, the speakers will share actionable best practices for maintaining a complete, audit-ready eTMF, and explore why the right technology foundation is critical to sustainable compliance.
The session will close with a moderated panel discussion led by Trial Interactive's Wei Du, giving attendees the opportunity to dive deeper into real-world challenges and solutions.
Whether you're refining your existing TMF strategy or building one from the ground up, this webinar delivers practical insight from both regulatory and sponsor perspectives.