New Approach Methodologies (NAM)-supported read-across (RAX): from case studies to regulatory guidance in safety assessment
Think tank meeting organised by EU-ToxRisk, in close collaboration with representatives from several European regulatory agencies (ECHA, EFSA, SCCS), US agencies (NTP, EPA), and other organisations (OECD, Health Canada, NIHS Japan.
Time: May 21-22, 2019
Venue: Hotel Korpilampi, Espoo, Finland
A group of more than 60 international experts from industry, academia, and regulatory authorities came to Espoo to discuss different case studies developed within EU-ToxRisk, but also at the OECD/IATA, and NIHS Japan programs.
This unique occasion allowed the collection of the scientific and regulatory expert feedback on various RAx scenarios, serving as input to an EU-ToxRisk advisory report for NAM-supported RAx. This advisory document will target the broader toxicology community. It will contain practical instructions on RAx applications in different regulatory contexts, to improve the quality of submissions by registrants and to increase the acceptance/success rate of non-animal approaches (press release).