New Approach Methodologies for Toxicology

Aim of the course

This module will provide participants with knowledge on what New Approach Methodologies (NAMs) can tell us about the toxicity of chemicals and how the outcome of NAMS can be integrated into a next generation risk assessment (NGRA), which is an exposure-driven, mechanistic risk assessment approach to assess safe levels of chemical exposures in humans and relies on non-animal test methods.

At present, the assessment of the safety of chemicals and pharmaceuticals for human health is still predominantly based on toxicity data derived from animal studies. Yet, there are important species differences between laboratory animals and humans. In addition, there is an increasing push from society to use a non-laboratory animal derived data in risk assessment. Therefore, risk assessors need to have a thorough state-of-the-art understanding of the strengths and weaknesses of (individual) NAMs and where they fit in the (next generation) risk assessment (i.e., exposure assessment, hazard identification, hazard characterisation and risk characterisation).

This course consists of lectures and tutorials providing participants with a concise overview of individual NAMs (including AOPs, read across, QSARs, in vitro toxicity and ADME assays, PBPK, QIVIVE and omics) and training in how they can be applied in chemical risk assessment. Participants will also discuss the societal, ethical and legal background to and consequences of this paradigm shift in toxicity testing away from animal testing.

After following this course, the participant will be able to

  • choose relevant methodologies to assess the risk of chemicals including drugs, cosmetics, industrial chemicals and contaminants;
  • understand the opportunities and hurdles of integrating NAMs in regulatory toxicology;
  • appreciate the ethical and sociological drivers behind a paradigm shift in risk assessment;
  • apply NAMs in their own field of work.

Coordinator(s): Dr. Hans Bouwmeester , Dr Nynke Kramer, Dr Anne Kienhuis, Dr. Marianne Bol-Schoenmakers

During the week students will work on an individual case study and integrate information from lectures and tutorials. On Friday, their NAMs-based risk assessment approach will be assessed.


Please note that the course can be cancelled up to one month before its starting date, when the number of applications is below the minimum required. For general inquiries please contact the PET Office.

Mutagenesis and Carcinogenesis