CO 062: THE ROLE OF THE BRAZILIAN CENTER FOR VALIDATION OF ALTERNATIVE METHODS (BraCVAM) IN THE PROCESS OF VALIDATION IN BRAZIL

J Pharm Pharmacogn Res 2(Suppl. 1): S38, 2014

Special supplement with the abstract book of LATINFARMA 2013

Oral Communication

CO 062: THE ROLE OF THE BRAZILIAN CENTER FOR VALIDATION OF ALTERNATIVE METHODS (BraCVAM) IN THE PROCESS OF VALIDATION IN BRAZIL: LOOKING TO THE FUTURE

Presgrave O, Moura W, Caldeira C, Delgado I.

Instituto Nacional de Controle de Qualidade em Saúde (INCQS)/Fundação Oswaldo Cruz (FIOCRUZ), Brasil. E-mail: octavio.presgrave@incqs.fiocruz.br
Abstract

Introduction: Brazilian Law 11,794/2008 rules the animal use and created the Council for the Control of Animal Experimentation (CONCEA) which is responsible, among many other activities, for making alternative methods official in Brazil. The Brazilian Center for Validation of Alternative Methods (BraCVAM) was created in order to identify laboratories and the need of validation, as well as organize and make feasible the execution of validation process.

Objectives: Show how BraCVAM expects to work in Brazil and its relation with similar organizations.

Results: BraCVAM will organize studies to be executed by the National Network on Alternative Methods (RENAMA) following OECD Guideline 34 and it will count on two Committees. The first will peer review the results during the validation and the second will evaluate and recommend finished result to CONCEA. RENAMA received a financial support from National Council of Technological and Scientific Development (CNPq) to help starting two lines: 1) introduction of already validated methods and 2) development of a skin model. It will also be used for starting the process of laboratories accreditation in GLP. BraCVAM was already invited for participating as an observer at the International Cooperation on Alternative Test Methods (ICATM) and to join the OECD Guideline Programme.

Conclusions: Creation of BraCVAM and RENAMA will lead Brazil to join countries that search for alternative methods either for experimental and educational purposes. It makes possible to participate on international studies for validation of methods as well as keep mutual evaluation and acceptance with international 3Rs Centers. BraCVAM and RENAMA will contribute to join institutions that work on alternative methods and it will be possible to develop its own validation strategy of new ingredients or products, especially those ones derived from nature. In a similar way, BraCVAM hope to help the development of networks in Latin America and Caribbean.