This symposium aims to guide a broad scientific and regulatory audience through the validation journey of New Approach Methodologies (NAMs). Using concrete case-study examples from established and emerging models, the event will clarify what “validation” means in practice, highlight the scientific and regulatory criteria required for acceptance, and illustrate how NAMs progress from academic innovation to applied decision-making tools. The symposium will showcase Swiss and international progress in the field, while fostering exchange between NAMs developers, end-users, and regulatory authorities.

Validation remains a key hurdle for the successful implementation of NAMs in human and environmental health risk assessment. This workshop will demonstrate validation process by outlining essential steps, from conceptual foundations such as Adverse Outcome Pathways (AOPs), through method development and performance benchmarking, to regulatory evaluation and integration into frameworks such as IATA and Defined Approaches. Through case studies spanning both mature, validated models and models still undergoing development and validation, participants will gain insight into success factors, common challenges and enabling mechanisms including quality assurance and fit-for-purpose principles. Bringing together researchers, industry practitioners, CROs, regulators, and policymakers, the symposium will not only show the validation journey with its hurdles and requirements but also promote dialogue on how Switzerland and Europe can promote the adoption of NAMs.

Confirmed speakers:

Session 1 – Validated and regulatory-accepted NAMs in practice: lessons from skin sensitisation

• Andreas Natsch, Givaudan Suisse SA


• Markus Hoffmann, Federal Office for Public Health (FOPH)

Session 2 – NAMs in the validation pipeline: progress in inhalation toxicity

• Barbara Rothen, Adolphe Merkle Institute, University of Fribourg

Session 3 – NAMs in the validation pipeline: frontiers in developmental neurotoxicity

• Kristina Heck, DNTOX GmbH


• Marie-Gabrielle Zurich Fontanellaz, University of Lausanne, & Nancy Hopf, Unisanté