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Course 2: New Approach Methodologies (NAMS) in Toxicology

Topics covered

Opportunities and challenges to implement and develop alternative and NAMs methods in Brazil
Advances in this field were accompanied by important regulatory frameworks, such as the toxicology report for the 21st century in 2007; The promulgation of the Arouca Law and the establishment of the National Council for Animal Experimentation Control (Concea) in Brazil in 2008, which regulates the use of animals in research and education; the ban on animal tests for cosmetics by the European Union in 2013; the 2023 US FDA modernization law, which removed the requirement of animal testing; and the 2023 Brazilian Law that requires the adoption of alternative methods for cosmetics evaluation. More recently, in November 2024 this year, Brazil enacted Law 15.022, which establishes the National Inventory of Chemicals and defines regulations for the risk assessment and control of chemicals produced or imported to the country. This presentation will highlight the example of the Laboratory of Education and Research in in vitro toxicology of the Federal University of Goiás, Brazil, in the implementation and development of alternative methods and NAM in Brazil. We have focused on intersectoral collaboration with gym, industry, CROS and regulators to use non -animal -based chemical evaluations throughout Brazil and Latin America, implementing and developing alternative and NAMS methods, as well as assisting researchers and communicating new methodologies advanced to accelerate regulatory adoption and acceptance.

 

9h00 – 10h15 Dr. Leila Bastos Leal (UFPE/Brazil)
Background on New Methodological Approaches (NAMs)
Alternative methods recognized in Brazil
Use of OECD TG 428 in the evaluation of cosmetics, medicines and pesticides

10h30 – 12h Dr. Marize C. Valadares (UFG/Brazil)
Advances in the development of alternative methods and NAMs (New Assessment Methodologies) have been accompanied by important regulatory frameworks in Brazil and around the world. This presentation highlights the work of the Laboratory of Education and Research in In Vitro Toxicology at the Federal University of Goiás, focused on the development of Alternative Methods and NAMs in Brazil. Our aim is to promote collaboration between academia, industry, CROs and regulators to implement non-animal chemical assessments throughout Brazil and Latin America, as well as supporting researchers and facilitating the adoption and regulatory acceptance of these new methodologies.


14h00-17h Dr. Vanja Dakic (Episkin/Brazil)
Ocular Irritation Test with Reconstructed Human Cornea Model (OECD TG 492B): The Reconstructed Human Cornea (HCE) represents a significant advance in ocular enhancement testing. This innovative method, self-sufficient in determining protection category, uses a 3D model that accurately replicates the structure and function of the human cornea, offering a reliable alternative to animal testing. The analysis of the effects of chemical substances on the HCE allows for a precise classification of risks, according to

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