Knowledge sharing to facilitate regulatory decision-making in regard to alternatives to animal testing: Report of an EPAA workshop.

Autor: Ramirez T; BASF SE, Ludwigshafen, Germany. Electronic address: tzutzuy.ramirez-hernandez@basf.com., Beken S; Federal Agency for Medicines and Health Products, Brussels, Belgium., Chlebus M; European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium., Ellis G; Givaudan International SA, Vernier, Switzerland., Griesinger C; European Commission, Joint Research Centre, Institute for Health and Consumer Protection, Ispra, Italy., De Jonghe S; Preclinical Development and Safety, Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium., Manou I; European Partnership for Alternative Approaches to Animal Testing (EPAA), Brussels, Belgium., Mehling A; BASF Personal Care and Nutrition GmbH, Düsseldorf, Germany., Reisinger K; Henkel AG & Co KGaA, Düsseldorf, Germany., Rossi LH; European Chemicals Agency, Helsinki, Finland., van Benthem J; National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands., van der Laan JW; Medicines Evaluation Board, Utrecht, The Netherlands., Weissenhorn R; European Commission, Directorate General Enterprise and Industry, Brussels, Belgium., Sauer UG; Scientific Consultancy - Animal Welfare, Neubiberg, Germany.
Jazyk: angličtina
Zdroj: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2015 Oct; Vol. 73 (1), pp. 210-26. Date of Electronic Publication: 2015 Jul 15.
DOI: 10.1016/j.yrtph.2015.07.007
Abstrakt: The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a workshop Knowledge sharing to facilitate regulatory decision-making. Fifty invited participants from the European Commission, national and European agencies and bodies, different industry sectors (chemicals, cosmetics, fragrances, pharmaceuticals, vaccines), and animal protection organizations attended the workshop. Four case studies exemplarily revealed which procedures are in place to obtain regulatory acceptance of new test methods in different sectors. Breakout groups discussed the status quo identifying the following facilitators for regulatory acceptance of alternatives to animal testing: Networking and communication (including cross-sector collaboration, international cooperation and harmonization); involvement of regulatory agencies from the initial stages of test method development on; certainty on prerequisites for test method acceptance including the establishment of specific criteria for regulatory acceptance. Data sharing and intellectual property issues affect many aspects of test method development, validation and regulatory acceptance. In principle, all activities should address replacement, reduction and refinement methods (albeit animal testing is generally prohibited in the cosmetics sector). Provision of financial resources and education support all activities aiming at facilitating the acceptance and use of alternatives to animal testing. Overall, workshop participants recommended building confidence in new methodologies by applying and gaining experience with them.
(Copyright © 2015 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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