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Navigating EMA’s Voluntary Data Submission Pilot for NAMs
Welcome to the DDReg Knowledge Capsule! In this episode, we unpack the EMA’s Voluntary Data Submission pilot for New Approach Methodologies (NAMs). Learn how drug sponsors and researchers can submit non-animal testing evidence for informal regulatory feedback, understand essential briefing package requirements, and explore how this initiative compares with FDA and MHRA frameworks.
For more info read our blog: https://resource.ddregpharma.com/blogs/ema-voluntary-data-submission-pilot-nams/
The skinny
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