Regulatory Affairs as a Cornerstone for NAMs Implementation: Building Collaborative Pathways with EU Health Authorities

Description: New Approach Methodologies (NAMs) represent not only additional preclinical models but also a fundamental paradigm shift in pharmaceutical R&D. This evolution addresses two critical needs: enhancing predictivity of human safety and efficacy outcomes while aligning with ethical imperatives to reduce animal testing.

Despite their potential, NAMs face implementation hurdles requiring key coordinated engagement between industry and regulatory bodies. EMA has pioneered the release of guidance on the process to submit NAMs models for evaluation.
Nevertheless, there’s still a need for a clear guide on how NAMs should be scientifically qualified and regulatorily validated, to foster their timely adoption in critical development pathways.

This session brings together regulatory experts from EMA and industry to explore how collaborative frameworks can accelerate NAMs integration into regulatory decision-making. It will examine the strategic involvement of regulatory affairs in early NAMs development, with one EMA speaker sharing the qualification pathways and validation approaches in Europe and the industry presenting case studies demonstrating successful regulatory engagement in NAMs implementation, and as well the practical roadmap for building necessary expertise within both industry and EMA.

Participants will gain insights into establishing effective regulatory strategies for NAMs deployment, understanding agency perspectives on validation requirements, and identifying steps toward concrete approaches that benefit patients through more predictive, ethical research methodologies.