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Modernizing Preclinical Testing: FDA and EMA Roadmaps for New Approach Methodologies
Session Chair(s)
Imein Bousnina, PHARMD, MSC
Director, US Regulatory Policy, Product Development Regulatory
Genentech, A Member of the Roche Group, United States
The session will give the audience an overview of FDA and EMA’s strategy to modernize their preclinical regulatory frameworks, as well as a clear understanding of industry’s current use of New Approach Methodologies (NAMs) in submissions.
Learning Objective : Understand FDA's objectives under their NAMs roadmap; Understand EMA's objectives under their NAMs workplan; Learn industry's experience so far submitting NAMs in regulatory applications.
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