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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
US Head, Modeling and Simulation, Sanofi, United States
Regulatory Perspective
Division Director, Division of Pharmacometrics, OCP, OTS, CDER, FDA, United States
Industry Perspective
Senior Director, Modeling and Simulation, Vertex Pharmaceuticals, United States
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