Next Generation Risk Assessment (NGRA): Emerging Best Practice & Opportunities for Regulatory Use

This will be the seventh webinar in the Risk Assessment Syllabus series, which began in 2021. This webinar will bring together many of the concepts covered in prior topics to show how new approach methodologies (NAMs) can transform the Human Health Risk Assessment (covered on June 9, 2021) to advance more predictive, efficient, and human-relevant risk evaluations. 

Paradigm Shift in Progress: Witnessing the Global Adoption of Next Generation Risk Assessment (NGRA) 

Gavin Maxwell, PhD, Head of Regulatory Science Strategy and Advocacy, Unilever 

Safety science has advanced a great deal since the 1950s when the only tools for assessing safety were animal tests. Decades of investment in New Approach Methodologies (NAMs) and Next Generation Risk Assessment (NGRA) approaches are enabling a global paradigm shift in regulatory science.    

Since the concept was defined in the US National Academies of Science “Toxicity Testing in the 21st Century: A Vision and a Strategy” in 2007 we have created a vast toolbox of NAM and NGRA approaches and built confidence in how to apply them using tiered frameworks and defined workflows to address a plethora of regulatory needs.  We have learnt that combining NAM data with exposure information using computational/AI approaches enables us to set, and assess against, more meaningful protection goals.  As a result, it is becoming increasingly clear that transitioning to NAMs and NGRA approaches can help us better protect people and enable the phase out of regulatory animal testing.    

So where are we today? After two decades of rapid progress, we find ourselves at a tipping point as we collectively transition from early adoption to widespread regulatory use of NAMs and NGRA approaches.  So, what have we learned and where do we go from here? This talk seeks to offer a global perspective on how far we’ve come in implementing the Toxicity Testing in the 21st Century vision and reflect upon how we can overcome remaining challenges together. A variety of published case studies, some of which are also regulatory submissions, will be presented to track/evidence scientific progress.