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Background In the scope of the European Commission Initiative on Breast Cancer (ECIBC) the Monitoring and Evaluation (M&E) subgroup was tasked to identify breast cancer screening programme (BCSP) performance indicators, including their acceptable and desirable levels, which are associated with breast cancer (BC) mortality. This paper documents the methodology used for the indicator selection. Methods The indicators were identified through a multi-stage process. First, a scoping review was conducted to identify existing performance indicators. Second, building on existing frameworks for making well-informed health care choices, a specific conceptual framework was developed to guide the indicator selection. Third, two group exercises including a rating and ranking survey were conducted for indicator selection using pre-determined criteria, such as: relevance, measurability, accurateness, ethics and understandability. The selected indicators were mapped onto a BC screening pathway developed by the M&E subgroup to illustrate the steps of BC screening common to all EU countries. Results A total of 96 indicators were identified from an initial list of 1325 indicators. After removing redundant and irrelevant indicators and adding those missing, 39 candidate indicators underwent the rating and ranking exercise. Based on the results, the M&E subgroup selected 13 indicators: screening coverage, participation rate, recall rate, breast cancer detection rate, invasive breast cancer detection rate, cancers > 20 mm, cancers ≤10 mm, lymph node status, interval cancer rate, episode sensitivity, time interval between screening and first treatment, benign open surgical biopsy rate, and mastectomy rate. Conclusion This systematic approach led to the identification of 13 BCSP candidate performance indicators to be further evaluated for their association with BC mortality.

EURL ECVAM DataBase service on ALternative Methods to animal experimentation In the regulatory assessment of chemicals, Quantitative Structure-Activity Relationship (QSAR) models are playing an increasingly important role in predicting properties needed for hazard and risk assessment. The JRC QSAR Model Database provides information on the validity of QSAR models that have been submitted to the JRC. The database is intended to help to identify valid QSARs, e.g. for the registration and authorisation purposes of chemical substances within the context of REACH Registration, Evaluation, Authorisation and Restriction of Chemicals (EC 1907/2006), a European Union regulation dated 18 December 2006. The QSAR Model Reporting Format (QMRF) is a harmonised template for summarising and reporting key information on QSAR models, including the results of any validation studies. The information is structured according to the OECD principles for the validation of QSAR models., JRC.F.3-Chemicals Safety and Alternative Methods

INTRODUCTION In the regulatory assessment of chemicals, Quantitative Structure-Activity Relationship (QSAR) models are playing an increasingly important role in predicting properties needed for hazard and risk assessment. The JRC QSAR Model Database provides information on the validity of QSAR models that have been submitted to the JRC. The database is intended to help to identify valid QSARs, e.g. for the registration and authorisation purposes of chemical substances within the context of REACH Registration, Evaluation, Authorisation and Restriction of Chemicals (EC 1907/2006), a European Union regulation dated 18 December 2006. The QSAR Model Reporting Format (QMRF) is a harmonised template for summarising and reporting key information on QSAR models, including the results of any validation studies. The information is structured according to the OECD principles for the validation of QSAR models., JRC.F.3-Chemicals Safety and Alternative Methods

EURL ECVAM DataBase service on ALternative Methods to animal experimentation To promote the development and uptake of alternative and advanced methods in toxicology and biomedical sciences. This publication is a Tutorial by the Joint Research Centre (JRC), the European Commission’s science and knowledge service. It aims to provide user support. The scientific output expressed does not imply a policy position of the European Commission. Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use that might be made of this publication., JRC.F.3-Chemicals Safety and Alternative Methods

Every year, EURL ECVAM prepares a Status Report with the primary purpose of which is to inform its stakeholders and all interested parties (the public, press etc.) on updates on the status of alternative methods and approaches. The EURL ECVAM status report provides updates on activities since the last report published in October 2016. It reports on research and development, validation activities as well as on activities which promote the regulatory and international adoption and use of alternative approaches and their dissemination. It describes primarily, but not exclusively, all the activities that EURL ECVAM has undertaken or has been involved in since the publication of the last report., JRC.F.3-Chemicals Safety and Alternative Methods

EURL ECVAM DataBase service on ALternative Methods to animal experimentation To promote the development and uptake of alternative and advanced methods in toxicology and biomedical sciences. This publication is a Tutorial by the Joint Research Centre (JRC), the European Commission’s science and knowledge service. It aims to provide user support. The scientific output expressed does not imply a policy position of the European Commission. Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use that might be made of this publication., JRC.F.3-Chemicals Safety and Alternative Methods

Replacement, Reduction and Refinement of animal testing is anchored in EU legislation. Alternative non-animal approaches facilitate a shift away from animal testing. Cell-based methods and computational technologies are integrated to translate molecular mechanistic understanding of toxicity into safety testing strategies., JRC.F.3-Chemicals Safety and Alternative Methods

The SEURAT-1 methods are here collected together and reported in the format of the database service that ensures OECD compliant descriptions. The information provided for for each methods is provided as reported and publicly available in the EURL ECVAM DataBase service on Alternative Methods, DB-ALM (http://ecvam-dbalm.jrc.ec.europa.eu/), developed and maintained by the Commission's Joint Research Centre. The aim of the FP7 SEURAT-1 Research Initiative is the development of a long-term research strategy leading to pathway-based human safety assessments in the field of repeated dose systemic toxicity testing of chemicals. The overall goal is to develop complementary theoretical, computational and experimental (in vitro) models that predict quantitative points of departure needed for human safety assessment and replace currently used animal testing., JRC.F.3-Chemicals Safety and Alternative Methods

In the context of the European Commission's Communication published in response to the European Citizens' Initiative "Stop Vivisection", Action 1 aimed to conduct an assessment of current technologies, information sources and networks from all relevant sectors with potential impact on the advancement of the refinement, reduction and replacement of animals used for scientific purposes (the "Three Rs"). The main objective of this study is to map knowledge sources relevant to the Three Rs, to examine how knowledge is being shared, and to identify possible gaps and opportunities to enhance knowledge sharing. An inventory of knowledge sources (KS) potentially relevant to the Three Rs used in the area of life sciences has been compiled which should be viewed as a snapshot of the current status of knowledge sources available (the supply), and as a starting point for further analysis of knowledge sharing strategies. A public survey was also conducted to complement this study (supply versus demand), and to inform on how to proceed effectively with any knowledge management strategy. The survey has revealed that many involved in this area consider that whilst access to relevant knowledge sources is adequate, there is a need for better coordination of the sources, as well as for the communication of information. Opportunities for face-to-face exchanges are highly valued and there is a firm call for more developments in education and training at professional, university and secondary school levels., JRC.F.3-Chemicals Safety and Alternative Methods

The EURL ECVAM status report provides an update on the progress made in the development, validation and regulatory acceptance of alternative methods and approaches and their dissemination since the last report published in June 2014. It is informing on ongoing research and development activities, validation studies, peer reviews, recommendations, strategies and regulatory/international acceptance of alternative methods and approaches and dissemination activities. R&D activities within large European or International consortia continued in toxicity areas where 3Rs solutions are more difficult to find due to the underlying complexity of the area. On the other hand, toxicity areas where promising non-animal approaches have been developed, their validation and regulatory acceptance/international adoption could be progressed. Particular emphasis was given to the best and most intelligent combination and integration of these different non-animal approaches to ultimately obtain the required information without resorting to animal testing., JRC.I.5-Systems Toxicology

The EURL ECVAM status report provides an update on the progress made in the development, validation and regulatory acceptance of alternative methods and approaches since the last report published in April 2013. It is informing on ongoing research and development activities, validation studies, peer reviews, recommendations, strategies and international acceptance of alternative methods and approaches. R&D activities are ongoing for the complex endpoints where the toxicological processes and the mechanistic understanding have not been sufficiently elucidated yet and for which 3Rs solutions are more difficult to find. On the other hand, good progress In the validation and regulatory acceptance is made in areas where non-animal alternative methods have been developed and validated and where the focus lies in an intelligent combination/ integration of the various non-animal approaches., JRC.I.5-Systems Toxicology

This state-of-the art review is based on the final report of a project carried out by the European Commission’s Joint Research Centre (JRC) for the European Chemicals Agency (ECHA). The aim of the project was to review the state of the science of non-standard methods that are available for assessing the toxicological and ecotoxicological properties of chemicals. Non-standard methods refer to alternatives to animal experiments, such as in vitro tests and computational models, as well as animal methods that are not covered by current regulatory guidelines. This report therefore reviews the current scientific status of non-standard methods for a range of human health and ecotoxicological endpoints, and provides a commentary on the mechanistic basis and regulatory applicability of these methods. For completeness, and to provide context, currently accepted (standard) methods are also summarised. In particular, the following human health endpoints are covered: a) skin irritation and corrosion; b) serious eye damage and eye irritation; c) skin sensitisation; d) acute systemic toxicity; e) repeat dose toxicity; f) genotoxicity and mutagenicity; g) carcinogenicity; h) reproductive toxicity (including effects on development and fertility); i) endocrine disruption relevant to human health; and j) toxicokinetics. In relation to ecotoxicological endpoints, the report focuses on non-standard methods for acute and chronic fish toxicity. While specific reference is made to the information needs of REACH, the Biocidal Products Regulation and the Classification, Labelling and Packaging Regulation, this review is also expected to be informative in relation to the possible use of alternative and non-standard methods in other sectors, such as cosmetics and plant protection products., JRC.I.5-Systems Toxicology