Objetivo
Specific Objectives:
Development of advanced test methods and testing strategies that could be used to replace, or reduce and refine, the use of animals for the testing of chemical substances, chemical products and biomaterials. Such methods include in vitro systems based on stem cells. Prevalidation and validation of alternative test methods and testing strategies for chemical substances and products, leading to reports on the outcome of (pre)validation studies and weight-of-evidence reviews. Coordination of the independent peer review of validated methods, leading to statements on the scientific validity of alternative methods. Provision of a publicly-available Scientific Information System on alternative methods and their development/validation studies Support to Commission services and other Customers, including: support to DG ENV, the future Chemicals Bureau, and the OECD in relation to alternative methods for chemicals testing support to DG ENV in relation to the Directive on the Protection of Laboratory Animals (Directive 86/609/EEC) support to DG ENTR and DG SANCO in relation to alternative methods for the testing of cosmetic products (Directive 76/768/EEC) support to DG ENTR, the Council of Europe and the EMEA in relation to methods for assessing the safety and efficacy of biologicals and medicines.
Anticipated milestones and schedule:
Most of the listed milestones/activities should be considered as a continuous process, which will require the whole year 2003. General Establish project management groups for all areas of chemical and cosmetic safety testing. Develop strategies and partnerships to set ECVAM's recent comprehensive review on the use of alternative test methods and testing strategies in relation to the Future EU Chemicals Policy into practice Establish a fund of chemical industry to further development and validation of alternatives Increase collaboration with ICCVAM, USA and harmonisation of activities Increase collaboration with OECD and host an OECD workshop on the validation of QSAR Continuation of the ECVAM PECO projects on the Three Rs and advanced testing methods and their validation Further development of the ECVAM Scientific Information Service (SIS) Coach FP6 research projects on the development of alternative methods Initiation/continuation/finalisation of several prevalidation/validation studies Organisation of ECVAM workshops Establishment of ECVAM Task Forces Start and expand the Marie Curie Training Site Specific Acute and Systemic Toxicity Continuation of a validation study with ICCVAM on the use of cytotoxicity tests to predict lethal toxic doses/concentrations in rodents and humans Starting of the collaborative study on the ability of cytotoxicity tests to predict maximum tolerated doses of anti-cancer drugs in rodents and humans Barriers Organisation of a workshop on the blood-brain barrier (May 2003) Establishment of a blood-brain barrier model using primary cells and astroglioma cell lines (part of a PhD project) Completion and evaluation of the adaptation and characterisation of epithelial cells to grow on culture medium supplemented with vegetal sera to replace animal sera Biocompatibility Establishment of an ECVAM Task Force on biomaterials in cooperation with the Biomaterials Unit In vitro models of human cells for the toxicity of metal-based alloys (metal ions and nanoparticles) Biologicals Comments on new/revised Ph. Eur.
Monographs Establishment of ECVAM Task Force on biologicals (1st quarter) Participation in the validation study of serological methods for the batch potency testing of C. perfringens vaccines (1st quarter) ECVAM Workshop on future (Three R) aspects in the quality control of biologicals (2nd quarter) Follow-up of the prevalidation study of physicochemical methods for potency testing of recFSH Sponsoring and participation in the validation of ELISA and ToBI for batch potency testing of tetanus immunoglobulins and antisera Continuation of the prevalidation study of PCRs for the batch safety testing of live avian vaccines Cardiotoxicity Establishment at ECVAM of commercially-available human embryonic stem cell lines as platform technology for the establishment of e.g. cardiotoxicity tests in vitro Carcinogenicity Evaluation of mouse fibroblasts Balb/3T3 as possible in vitro cell transformation model to be prevalidated Evaluation of carcinogenicity hazard assessment of arsenic, chromium and platinum compounds Development of in vitro human cell transformation assays (use of human haematopoietic stem cell differentiation from umbilical cord blood) Critical review on in vitro carcinogenic potential of metal compounds in comparison to in vivo animal and human carcinogenesis data Chronic Testing Establishment of a long-term cell culture system to study polyethylene wear debris cytotoxicity ECVAM Scientific Information Service (SIS) Updating of the SIS database contents - Organisation of regular working meetings and/or maintaining individual contacts with external experts, partly under contract, for the definition of new data sheets for the various sectors of the SIS databases Provision of an integrated SIS Internet version - Organisation of regular working meetings with external experts under contract (defined in 2002) for the implementation of a new SIS Internet version with additional data sectors and navigation facilities (the work is subdivided into modules to be delivered regularly and each requires confirmation by the responsible of SIS, the whole activity will require the whole 2003 and started already in December 02) - Definition of the contract for the development of the local management system (data entry/modify/cancel) for the SIS Internet version (3rd quarter 2003) Provision of an Internet version of the ECVAM Thesaurus - Development based on step-by-step deliveries within a contract which requires formal approval by the responsible for SIS (4th quarter 2003) followed by a subsequent update to be carried out by the SIS staff before presenting it to the public Monthly update of the content of the ECVAM web site Good Laboratory Practice and Good Cell Culture Practice Organisation of a workshop on Good Cell Culture Practice (2nd quarter 2003) Joint activity with OECD: Compilation of a guidance document on Good Laboratory Practice in vitro studies
Haematotoxicity and Anti-cancer Drugs Study of gene expression in cord blood-derived haematopoetic stem cells P53 mutational spectra as a marker of exposure to chemical compounds Standardisation of stem cells culture protocols Coordination of the interlaboratory prevalidation study on the response of primary cultured human hepatocytes to model inducers Metal Toxicity Exploitation of the new bioradioanalytical laboratories at the cyclotron to study correlations between cellular uptake, metabolism and toxicological effects of selected metal compounds (and other chemicals) in vitro; the type of effects under consideration will be carcinogenicity, neurotoxicity, nephrotoxicity and chronic toxicity, skin irritation, reproductive toxicity, immunotoxicity, biocompatibility; the metals studied will be relevant to environmental and occupational human exposure, drug therapy, and use of food and cosmetics Evaluation of an integrated testing strategy for toxicity hazard assessment of arsenic, chromium, mercury and platinum compounds Evaluation of an in vitro rabbit sperm model of infertility and metal- induced spermiotoxicity Critical reviews on: a) in vitro effects of metal compounds on immune system in comparison to in vivo animal and human data b) metals in cosmetology Molecular Biology Further establishment and integration of expertise in molecular biology Initiation of activities in toxicogenomics Organisation of a workshop on the validation of toxicogenomics
Neurotoxicity Evaluation of the applied use of neuronal cell lines for neurotoxicity hazard assessment Evaluation of the applied use of freshly isolated and cryopreserved 3- dimensional reaggregating brain cell cultures for neurotoxicity hazard assessment Evaluation of the applied use of freshly isolated neurons and glias for the establishment of an in vitro neurotoxicity model specifically using deregulation of neuronal inflammatory responses to predict neurotoxic hazard Pyrogenicity Completion of pyrogen validation study (1st quarter 2003), exploitation of results for biomaterials, air-borne pyrogens and cellular therapies and for horizontal activities at Unit, Institute and JRC level Reproductive Toxicity Quality assurance and standardisation of embryonic stem cell use Prevalidation of the Leydig cell model as a follow-up study of a DG RTD project Organisation of a workshop on the application and further development of the validated embryotoxicity tests (1st quarter 2003) Topical Toxicity and Human Studies Organisation of a workshop on the design of a validation study on skin irritation (1st/2nd quarter 2003) Initiation of a validation study on skin irritation (1st/2nd quarter 2003) Contribute to a prevalidation study on the use of a reconstituted epidermis for phototoxic potency testing Initiation of weight-of-evidence validation of in vitro tests (IRE, ICE, HET-CAM, BCOP (NRR, Agarose Diffusion Method) for eye irritation Continuation of the collaborative study on skin irritation testing with non- invasive technology and human volunteers Validation Establishment of an ECVAM Task Force on Weight-of-Evidence Validation Compilation of a guidance document on Good Validation Practice in a joint effort with OECD and ICCVAM Organisation of an internal validation course for IHCP units (1st quarter 2003) Please note that the validation studies are listed under the individual tasks
Planned Deliverables:
Study reports/publications Report on the outcome of a study on the use of a cell culture medium supplemented with vegetal serum to replace animal sera Report on the outcome of a research study using Ochratoxin A on renal proximal tubular cell lines Final report and follow up of the prevalidation study on trans-epithelial resistance and inulin permeability as endpoints in vitro nephrotoxicity testing Finalisation of the ECVAM study on development and refinement of the Caco- 2 cell model for intestinal barrier function.
A final report with way forwards (prevalidation/validation study) for intestinal barrier function is foreseen Completion of a pilot study on monitoring gene expression as early marker of chemical exposure and preparation of a manuscript to be published in a peer reviewed journal Establishment of a DNA chip to test the toxicity of chemicals to human haematopoietic cells and preparation of a manuscript to be published in a peer reviewed journal ECVAM workshop reports ECVAM workshop report on blood-brain barrier ECVAM workshop report on Three Rs approaches in the quality control of rabies vaccines ECVAM workshop report on future (Three R) aspects in the quality control of biologicals ECVAM workshop report on the application and further development of the validated embryotoxicity tests ECVAM workshop report on Good Cell Culture Practice ECVAM workshop report on the validation of toxicogenomics ECVAM workshop report on fish cells in environmental toxicology Guidance documents ECVAM/OECD document on Good Laboratory Practice in vitro studies ECVAM/ICCVAM/OECD document on Good Validation Practice Guidance document on the principles of weight-of-evidence validation Standardised/Prevalidated/Validated methods Note: dependent on the outcome of ongoing development/prevalidation/validation studies (see Milestones) ESAC Statements ESAC statement on the scientific validity of CFU-GM test for haematotoxicity testing ECVAM SIS Updated SIS database contents with new information for the Methods- (Summary descriptions and the INVITTOX protocols), Test Result- and on Validation Studies data sectors covering metabolism-mediated toxicity and hepatotoxicity, percutaneous absorption and neurotoxicity New integrated Internet version of the SIS Internet version of the ECVAM Thesaurus Updated contents of the ECVAM web site.
Summary of the Action:
The overall aim of this action is to provide support to the new Chemicals Policy through the development, validatation and promotion of non-animal methods, especially those designed for the testing of chemical substances and products (including cosmetics, medicines and biologicals) and biomaterials. Rationale The new EU Chemicals Policy will require the assessment of some 30,000 chemicals, which will have serious financial and animal welfare implications, unless alternative methods are developed and validated, and eventually implemented in the context of the REACH system. The validation of non-animal methods at the EU level should be conducted and/or coordinated by an independent body, which is free of national and sectoral interests. This is one of the main reasons why ECVAM (European Centre for Validation of Alternative Methods)was established at JRC. In addition, the JRC is a suitable platform for the exchange of information, such as information on alternative methods. Also, DG ENV will continue to need expert advice from the JRC in relation to ongoing amendments to Directive 86/609/EEC on the protection of laboratory animals, and to Directive 76/768/EEC on cosmetics testing. The Action could also contribute to future needs of DG ENV in relation to a new directive on tissue engineering, and Directive 98/79/EC on in vitro diagnostic medical devices.
Ámbito científico (EuroSciVoc)
CORDIS clasifica los proyectos con EuroSciVoc, una taxonomía plurilingüe de ámbitos científicos, mediante un proceso semiautomático basado en técnicas de procesamiento del lenguaje natural. Véas: El vocabulario científico europeo..
CORDIS clasifica los proyectos con EuroSciVoc, una taxonomía plurilingüe de ámbitos científicos, mediante un proceso semiautomático basado en técnicas de procesamiento del lenguaje natural. Véas: El vocabulario científico europeo..
- ciencias médicas y de la salud biotecnología médica ingeniería de tejidos
- ciencias médicas y de la salud medicina básica inmunología
- ciencias médicas y de la salud biotecnología médica tecnologías celulares células madre
- ciencias médicas y de la salud medicina básica farmacología y farmacia medicamento vacuna
- ciencias médicas y de la salud medicina básica toxicología
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Programa(s)
Programas de financiación plurianuales que definen las prioridades de la UE en materia de investigación e innovación.
Programas de financiación plurianuales que definen las prioridades de la UE en materia de investigación e innovación.
Tema(s)
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Las convocatorias de propuestas se dividen en temas. Un tema define una materia o área específica para la que los solicitantes pueden presentar propuestas. La descripción de un tema comprende su alcance específico y la repercusión prevista del proyecto financiado.
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Procedimiento para invitar a los solicitantes a presentar propuestas de proyectos con el objetivo de obtener financiación de la UE.
Régimen de financiación
Régimen de financiación (o «Tipo de acción») dentro de un programa con características comunes. Especifica: el alcance de lo que se financia; el porcentaje de reembolso; los criterios específicos de evaluación para optar a la financiación; y el uso de formas simplificadas de costes como los importes a tanto alzado.
Régimen de financiación (o «Tipo de acción») dentro de un programa con características comunes. Especifica: el alcance de lo que se financia; el porcentaje de reembolso; los criterios específicos de evaluación para optar a la financiación; y el uso de formas simplificadas de costes como los importes a tanto alzado.
Coordinador
21020 Ispra
Italia
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