Integrating the Risk Based Principles of ICH E6 R3 to Drive TMF Inspection Steadiness

About this session

Part of Session 6, Track D: Risk Based Approaches (Chair: Donna Dorozinsky, Just in Time GCP).

ICH E6(R3) guideline introduces a modernized, risk-based framework for quality management that aligns nicely with the forthcoming TMF SM V1. Together, these both create unique opportunities to transform TMF management into a more data-driven, risk-informed discipline.
This session examines how risk-based principles from ICH E6 can be systematically integrated with TMF standardization efforts to support inspection steadiness. The presentation will explore how standardized TMF metadata, taxonomy, and controlled terminology can be leveraged to identify critical-to-quality record types, quantify risk, and enable proactive quality oversight.
Attendees will gain practical perspectives on aligning Quality Risk Management (QRM) methodologies with standardized TMF structures, including the use of metrics that matter within a harmonized data framework. The session will also address how structured TMF data can enhance transparency, facilitate analytics, and support regulatory expectations for traceability and inspection readiness in a risk-proportionate environment.

Speakers

• DN

  Dawn Niccum

  inSeption Group

  Speaker

• DD

  Donna Dorozinsky

  Just in Time GCP

  Chair