This webinar explores how Model-Informed Drug Development (MIDD) supports drug development and patient care by informing dosing strategies beyond clinical trial data. Through real-world case examples—such as guiding dosing after treatment interruptions and optimizing dosing for an ocular implant—we’ll highlight how MIDD aids decision-making, streamlines development, and reduces patient burden without additional trials.

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.

The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.