ProtoQSAR presents the regulatory implications of applying computational methods
Our colleague Dr. Josefa Tolosa has presented the seminar “Computational alternatives to animal experimentation: regulatory considerations” in the Conference “Chemical risks and their evaluation by the European Committees”.
This event, which has reached its ninth edition, has been jointly organized by the General Sub-Directorate for Health and Environment (Ministry of Health, Consumption and Welfare), the Business Federation of the Spanish Chemical Industry (FEIQUE) and the Spanish Network on Alternative Methods to Animal Experimentation (REMA) in collaboration with EURL-ECVAM, the European Reference Laboratory on Alternatives to Animal Experimentation. Its objective was to spread the activity of different European committees with functions related to chemical risk assessment, the protection of experimental animals and the promotion of alternatives.
In the first two sessions of the day, the European Chemicals Agency (ECHA) and its Committees were presented, as well as the Committees related to Chemical Risks in other agencies such as the European Medicines Agency (EMA) and the European Food Safety Authority (EFSA).
In the last session, dedicated to the validations and strategies of alternative methods, Dra. Tolosa made an exhaustive review of the different regulations in which the QSAR models have a regulatory impact, such as Regulation 1907/2006 for the registration, evaluation and authorization of chemical compounds (REACH), the ICH guide for the evaluation of mutagenesis/carcinogenesis of impurities in pharmaceutical products, the 528/2012 regulation of biocidal products (BPR), the regulation 1107/2009 concerning the commercialization of phytosanitary products (PPP), or the regulation 1223/2009 on cosmetic products. All these norms share to a large extent the acceptance of QSAR computational methods as an alternative to traditional tests when they are developed following standardized and recognized guidelines such as those used in ProtoQSAR, and several examples of their application were presented during the seminar.
