This webinar explores strategies for implementing risk-based quality control (QC), emphasizing the use of peer-review QC to optimize robust validation. By tailoring the QC level to project-specific risk factors such as analysis purpose and data complexity, the delivery process for high-quality pharmacometric analysis datasets can be streamlined. The session will discuss differentiating between QC levels, such as self-QC, peer review, and double programming. Participants will discover practical methods for fostering collaboration, establishing clear data derivation rules, and utilizing comprehensive QC checklists, particularly for peer-review processes. Additionally, the webinar will highlight tools to support peer-review QC, enhancing QC efficiency and effectiveness.

This webinar discusses the ADaM sub-team's efforts in creating a CDISC ADaM standard for Population PK analysis. It addresses challenges in software compatibility and limited adoption of ADaM standards. The presentation emphasizes a BDS-like implementation for PopPK, managing differences between CDISC standards and analysis needs. The benefits of ADPPK standards are highlighted for enhancing quality, efficiency, and industry collaboration, with insights from the FDA on adoption.

In this presentation the speakers highlight the updates in the latest FDA Guidance for Population PK that impact the PMx Datasets, Report and eSub aspects. They provide some discussion and recommendations on how to incorporate the changes into the submission package.