title: Knowledge sharing to facilitate regulatory decision-making in regard to alternatives to animal testing: Report of an EPAA workshop.
abstract: 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.
authors.affiliation: BASF SE, Ludwigshafen, Germany. Electronic address: tzutzuy.ramirez-hernandez@basf.com.
authors.forename: Tzutzuy
authors.initials: T
authors.lastname: Ramirez
authors.affiliation: Federal Agency for Medicines and Health Products, Brussels, Belgium.
authors.forename: Sonja
authors.initials: S
authors.lastname: Beken
authors.affiliation: European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium.
authors.forename: Magda
authors.initials: M
authors.lastname: Chlebus
authors.affiliation: Givaudan International SA, Vernier, Switzerland.
authors.forename: Graham
authors.initials: G
authors.lastname: Ellis
authors.affiliation: European Commission, Joint Research Centre, Institute for Health and Consumer Protection, Ispra, Italy.
authors.forename: Claudius
authors.initials: C
authors.lastname: Griesinger
authors.affiliation: Preclinical Development and Safety, Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.
authors.forename: Sandra
authors.initials: S
authors.lastname: De Jonghe
authors.affiliation: European Partnership for Alternative Approaches to Animal Testing (EPAA), Brussels, Belgium.
authors.forename: Irene
authors.initials: I
authors.lastname: Manou
authors.affiliation: BASF Personal Care and Nutrition GmbH, Düsseldorf, Germany.
authors.forename: Annette
authors.initials: A
authors.lastname: Mehling
authors.affiliation: Henkel AG & Co KGaA, Düsseldorf, Germany.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Reisinger
authors.affiliation: European Chemicals Agency, Helsinki, Finland.
authors.forename: Laura H
authors.initials: LH
authors.lastname: Rossi
authors.affiliation: National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
authors.forename: Jan
authors.initials: J
authors.lastname: van Benthem
authors.affiliation: Medicines Evaluation Board, Utrecht, The Netherlands.
authors.forename: Jan Willem
authors.initials: JW
authors.lastname: van der Laan
authors.affiliation: European Commission, Directorate General Enterprise and Industry, Brussels, Belgium.
authors.forename: Renate
authors.initials: R
authors.lastname: Weissenhorn
authors.affiliation: Scientific Consultancy - Animal Welfare, Neubiberg, Germany.
authors.forename: Ursula G
authors.initials: UG
authors.lastname: Sauer
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods*; D000818:Animals; D003358:Cosmetics / Q000737:chemistry; D003657:Decision Making; D007221:Industry / Q000379:methods; D007391:International Cooperation; D018675:Toxicity Tests / Q000379:methods*
chemical_list: D003358:Cosmetics
keywords: 3Rs principle (replace, reduce, refine animal testing); Alternatives to animal testing; Cross-sector collaboration; Data sharing; International harmonization; Regulatory acceptance; Regulatory toxicology; Research framework programmes; Test method validation