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ICH M15 Model Informed Drug Development: Steps Toward Harmonized Guidance
Session Chair(s)
Erin Greene, JD
US Lead, Global Regulatory Policy and Innovation
Takeda, United States
Model Informed Drug Development (MIDD) can enhance the efficiency of drug development and regulatory decision-making. The ICH M15 guideline aims to enable the further integration and consistent use of MIDD. This session will cover the draft guideline in greater detail.
Learning Objective : Discuss the draft guideline and what may be new to drug developers and the regulatory community, including the concept of a risk-based assessment, the value of multidisciplinary team alignment on MIDD strategy, and early alignment with regulators; Identify current approaches, best practices, and future opportunities to enhance development and decision-making.
Speaker(s)
Industry Perspective
Malidi Ahamadi
Sanofi, United States
US Head, Modeling and Simulation
Regulatory Perspective
Hao Zhu, PhD
FDA, United States
Division Director, Division of Pharmacometrics, OCP, OTS, CDER
Industry Perspective
Mark C. Peterson, PhD
Vertex Pharmaceuticals, United States
Senior Director, Modeling and Simulation
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