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April 28 marked an important shift in the UK regulatory landscape, and TMF teams are being asked to do more than maintain organized records. They are being expected to demonstrate oversight, support quality by design, and maintain documentation that reflects how the trial was actually managed. With changes of this scale, teams need to understand not only what is changing, but also how those changes may affect day to day TMF practices and where unforeseen challenges could begin to surface.
In this session, Gill Gittens and Laurel-Ann Schrader will break down what ICH E6(R3) and recent MHRA guidance mean in practice for TMF teams, sponsors, and CRO partners. This discussion will focus on the real impact of these expectations, where teams often get stuck, and how to apply the guidance in a way that supports inspection readiness without creating unnecessary complexity.
Attendees will gain practical insight into how risk proportionate thinking, oversight, documentation practices, and TMF quality expectations are evolving and what teams should be doing now to stay ahead rather than fall behind. It is a valuable opportunity to hear directly from experts and better prepare for both expected changes and the issues teams may not see coming.