Journal article
Workshop on the validation and regulatory acceptance of innovative 3R approaches in regulatory toxicology - Evolution versus revolution
Federal Institute for Risk Assessment1
Department of Health Technology, Technical University of Denmark2
Evonik Performance Materials GmbH3
Research Group for Molecular and Reproductive Toxicology, National Food Institute, Technical University of Denmark4
Copenhagen Center for Health Technology, Centers, Technical University of Denmark5
National Food Institute, Technical University of Denmark6
Swiss 3R Competence Centre7
Utrecht University8
BASF9
21st Century Tox Consulting10
National Institute of Environmental Health Sciences Research11
Cosmetics Europe – The Personal Care Association12
National Institute of Public Health and the Environment13
Johns Hopkins Bloomberg School of Public Health14
Humane Society International15
...and 5 moreAt a joint workshop organized by RIVM and BfR, international experts from governmental institutes, regulatory agencies, industry, academia and animal welfare organizations discussed and provided recommendations for the development, validation and implementation of innovative 3R approaches in regulatory toxicology.
In particular, an evolutionary improvement of our current approach of test method validation in the context of defined approaches or integrated testing strategies was discussed together with a revolutionary approach based on a comprehensive description of the physiological responses of the human body to chemical exposure and the subsequent definition of relevant and predictive in vitro, in chemico or in silico methods.
A more comprehensive evaluation of biological relevance, scientific validity and regulatory purpose of new test methods and assessment strategies together with case studies that provide practical experience with new approaches were discussed as essential steps to build up the necessary confidence to facilitate regulatory acceptance.
Language: | English |
---|---|
Year: | 2019 |
Pages: | 1-11 |
ISSN: | 18793177 and 08872333 |
Types: | Journal article |
DOI: | 10.1016/j.tiv.2019.03.039 |
ORCIDs: | Vinggaard, Anne Marie |