Tailwinds for MIDD: EMA, FDA, and a Converging Regulatory Landscape

Regulators on both sides of the Atlantic are converging on the same conclusion: model-informed drug development (MIDD) should be central to how evidence is built and evaluated across drug development. ICH M15 has established the first harmonized global framework for MIDD, giving EMA and FDA a shared reference point for how modeling evidence is planned, submitted, and assessed.

At the same time, evolving initiatives and guidance from both agencies are creating new opportunities for sponsors to use modeling more strategically throughout drug development. In Europe, EMA’s Methodology Working Party and its qualification pathway continue to expand the routes through which modeling approaches gain formal regulatory standing. In parallel, FDA’s Operation TrialBlazer guidances, including new recommendations for Quantitative Systems Pharmacology (QSP)-based dose selection in first-in-human (FIH) trials, signal similar momentum toward formalizing modeling’s role in regulatory decision-making.

Together, these developments point to growing confidence in MIDD approaches as trusted contributors to the evidence package, not just supporting analyses. For sponsors running global programs, the question is no longer whether to use MIDD, but how to build a modeling strategy that can stand up to regulatory scrutiny from both agencies.

This exclusive, in-person session brings together three of Certara’s scientific leaders across Pharmacometrics, and Model-Based Meta-Analysis (MBMA), Physiologically based pharmacokinetics (PBPK), and Quantitative Systems Pharmacology (QSP) for a candid, cross-disciplinary discussion on this momentum and how sponsors can capitalize on it by building modeling strategies that give them the best chance of success with regulators in Europe and the U.S.