The crea(on and implementa(on of the Brazilian Network on Alterna(ve Test Methods

Tamanho: px

Começar a partir da página:

Download "The crea(on and implementa(on of the Brazilian Network on Alterna(ve Test Methods"

Emanuel Flores Domingues
8 Há anos
Visualizações:

1 The crea(on and implementa(on of the Brazilian Network on Alterna(ve Test Methods Workshop Toxicogenomics Universidade Federal do Paraná September 2014

2 Outline First Steps Vision and mo(va(on to create RENAMA Ins(tu(onal structure Governance Interlab ini(a(ve Recent Ini(a(ves Calls for proposals First valida(on (HET- CAM) Next Steps

3 Vision and mo2va2on to create RENAMA Lack of exis2ng ini2a2ves related to alterna2ve methods un2l 2010; To adopt and develop alterna2ve methods for replacement or reduc2on of animal use in research and regulatory (non- clinical trials); To promote synergy between research groups; To create a na2onal infrastructure (labs and human resources); To promote economic efficiency of public funds

4 The Network targets the adoption, development and validation of alternative methods; including technologies catchin-up and supplying services for both public and private sectors RENAMA was designed in late 2010 and its initial actions took place in mid 2011 as a project contracted by MCTI, via CNPq

5 Ministerial Act number 491/2012 Creates the Rede Nacional de Métodos Alterna(vos - RENAMA and its structure is under the Ministério da Ciência, Tecnologia e Inovação - MCTI, which will be supervised by a Steering CommiQee RENAMA s objejves: Rede Nacional de Métodos Alterna2vos RENAMA I. S(mulate the adop(on of alterna(ve methods via support and training; II. Monitor the performance of RENAMA s Labs via interlab assays; III. Promote the quality of assays; IV. S(mulate the implementa(on of quality systems and GLP principles; and V. Promote the development, valida(on and cer(fica(on of new alterna(ve methods.

6 RENAMA is composed by two categories of laboratories: 1. Central Labs Rede Nacional de Métodos Alterna2vos RENAMA 2. Associated Labs - public or private ins(tu(ons, with some level of exper(se on alterna(ve methods; - it should contribute to the dissemina(on / development of alterna(ve methods and offer its laboratorial infrastructure to RENAMA - an agreement for technical coopera(on between the Central Labs and the Associated Lab is necessary for joining RENAMA All RENAMA laboratories should have R&D acjvijes

7 Steering CommiTee: I. Ministério da Ciência Tecnologia e Inovação MCTI (coordinates); II. III. IV. Ins2tuto Nacional de Metrologia Qualidade e Tecnologia - INMETRO; Ins2tuto Nacional de Controle de Qualidade em Saúde - INCQS; Laboratório Nacional de Biociências - LNBio; V. Representa2ve from Associated Labs; VI. Agência Nacional de Vigilância Sanitária ANVISA; VII. Centro Brasileiro de Validação de Métodos Alterna2vos - BraCVAM; VIII. Conselho Nacional de Desenvolvimento Cien[fico e Tecnológico - CNPq; IX. Agência Brasileira de Desenvolvimento e Inovação - ABDI; X. Conselho Nacional de Controle de Experimentação Animal - CONCEA.

8 RENAMA s Steering CommiTee mandate: to oversee RENAMA s ac(vi(es; to define RENAMA s strategic ac(ons; to deliberate associated labs proposals for joining RENAMA; to evaluate the projects under development within RENAMA; and to deliberate RENAMA s projects con(nuity or interrup(on.

9 2011 OrganizaJon and management In 2011 first funding to Central Labs for se_ng up an infrastructure to run the following tests (suplemented in 2013) Citotoxicity in vitro (Guideline 129); Bovine Corneal Opacity and Permeability Test - BCOP (Guideline 437); Photo- cytotoxicity (Guideline 432); In Vitro Skin Irrita(on: Reconstructed Human Epidermis Test Method (Guideline 439); Monocyte Ac(va(on Test (MAT); Interlab assays First round ( ) to evaluate RENAMAFlux System and also a pilot for RENAMA Labs Citotoxicity in vitro (Guideline 129); To stablish the viability of RENAMAFlux System; Iden(fy gaps and issues that could compromised results quality; Five labs enrolled

10 RENAMAFlux System RENAMAFlux System was adopted by all RENAMA s labs One- stop- shop for interlab assays Assure that raw data is automajcally uploaded IniJate GLP principles culture

11 ii) Call for Proposals MCTI/CNPq - Nº 25/ Apoio a projetos para estruturação da Rede Nacional de Métodos AlternaJvos RENAMA 10 projects were selected; Theme 1 Fund projects for the implementa(on of validated alterna(ve methods; Theme 2 Fund project(s) for the development and valida(on of Reconstructed Human Epidermis Test Method (Guideline 439).

12 iii) Call for proposals: in silico trials ( LNBio) The call was designed to offer computa(onal tools for screening of small molecules candidates for new products, drugs or cosme(cs; Projects from the following insjtujons were selected Cristália Produtos Químicos e Farmacêu7cos LTDA. Eurofarma Laboratórios S/A Fundação Oswaldo Cruz Grupo Bo7cário Ins7tuto de Tecnologia de Fármacos em Manguinhos (Farmanguinhos) Natura Inovação e Tecnologia de Produtos LTDA. Única Educacional

13 iv) 2014 Fund a validajon study - HET- CAM assay under RENAMA v) Fund a project to establish transgenic cell lines for in vitro assays using HTS and HCS

14 InteracJon with the regulatory bodies and private sector MCTI is holding mee(ngs with ANVISA and CONCEA in order to promote the acceptance of alterna(ve methods by regulatory. As result, the Board of ANVISA has accepted 15 validated alterna(ve methods as non- clinical trials to be included in the dossier for registra(on MCTI is holding meetings, through ABDI, with representatives from the private sector in order to map their toxicological studies needs.

16 Thank you!

Documentos relacionados

RENAMA The Brazilian Network for Alternative Methods

RENAMA The Brazilian Network for Alternative Methods Luiz Henrique Mourão do Canto Pereira National Coordinator for Biotechnology and Health Ministry of Science, Technology and Innovation Progress on alternative