New Approach Methodologies (NAMs) present alternatives to traditional animal-based methods and allow for rapid and effective prioritization and safety assessment of pharmaceuticals and chemicals. In order to achieve international adoption and regulatory acceptance of NAMs, they need to be sufficiently validated and in a way that is fit for the purpose of chemical risk and safety assessment.

In this webinar, we will:

• Introduce the journey of a NAM from the start of development, optimization and standardization to uptake in globally harmonized regulatory frameworks
• Share our experience with validation of NAMs, their intra- and inter-laboratory reproducibility
• Discuss the adoption of NAMs internationally for decision making on the safety of medicinal products.

We will also share our experience with the interlaboratory validation of our ToxTracker assay whose draft OECD guideline is currently under review as well as development of the ReproTracker assay.

Presentations by:

Giel Hendriks

CEO at Toxys

Jose Manuel Horcas Nieto

Director Developmental Toxicology at Toxys

Webinar on NAMs validation

When: 26 February 2025, 4:00-5:00 pm CET