This symposium co-organised with the Swiss Centre for Applied Human Toxicology

(SCAHT) 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 the 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 (Integrated Approaches to Testing and Assessment) 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 (Contract Research Organisations),

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.

Check out the full symposium programme

here.

Confirmed speakers

KEYNOTE

• João Barroso, European Commission, Joint Research Centre (JRC)

Session 1 – Regulatory-accepted NAMs in practice: Lessons learned from skin sensitisation

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


• Andreas Natsch, Givaudan Suisse SA

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

• Sabine Frey, Federal Office for Public Health (FOPH)


• Samuel Constant, Epithelix Sàrl


• Barbara Rothen-Rutishauser, Adolphe Merkle Institute, University of Fribourg

Session 3 – Expanding the NAM landscape: Frontiers in developmental neurotoxicity

• Iris Mangas, European Food Safety Authority (EFSA)


• Kristina Heck, DNTOX GmbH


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

Session 4 – The future of NAMs: Roadmaps for regulatory uptake

• Ellen Fritsche, Swiss Centre for Applied Human Toxicology (SCAHT)


• Fiona Sewell, National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs)