Newsroom
RSNN Expert Meeting Report: New Approach Methodologies (NAMS)
On 23 May 2023, the Regulatory Science Network Netherlands (RSNN) organized an expert meeting on the topic of: 'Facilitating human relevant safety assessment of medicinal products: towards implementation of new approach methodologies (NAMs)’. The report of the meeting is available now.
For decades, efforts have been undertaken to accelerate the development of NAMs such as complex in vitro methods like Organ-on-Chip, 3D tissue engineering, organoid cultures and stem cell technologies, and artificial Intelligence-based analyses. NAMs are considered to improve risk assessment decisions, and to be able help to reduce and/or replace the use of animals in safety testing.
Regardless of the potential of NAMs to improve risk assessment decisions, the uptake of NAMs in regulatory safety assessment of medicinal products is limited due to several reasons.
The goal of the RSNN expert meeting was to provide a current overview of what steps need to be taken towards implementation of NAMs and which organisations are involved. Gaining insight in this ‘implementation curve’ is an essential first step to accelerate the implementation of NAMs.
The results of the meeting, including the first steps towards the development of the implementation curve, are available in the meeting report, which can be found here.