Suchergebnisse

Safety assessment of chemicals and products in the European Union (EU) is based on decades of practice using primarily animal toxicity studies to model hazardous effects in humans. Nevertheless, there has been a longstanding ethical concern about using experimental animals. In addition, animal models may fail to predict adverse effects in humans. This has provided a strong motivation to develop and use new approach methodologies and other alternative sources of evidence. A key challenge for this is integration of evidence from different sources. This paper is a call for action with regard to development, validation, and implementation of modern safety assessment approaches for human health assessment by means of focused applied research and development with three strands: (a) to improve screening and priority setting, (b) to enhance and partially replace animal studies under the current regulatory schemes and eventually (c) to fully replace animal studies, while achieving at least the same level of protection. For this gradual but systematic replacement of animal studies, a long-term concerted and coordinated effort with clear goals is needed at EU level, as a societal and political choice, to plan and motivate research and innovation in regulatory safety assessment.

From Elsevier via Jisc Publications Router ; History: accepted 2020-11-24, issue date 2020-11-26 ; Article version: AM ; Publication status: Accepted ; Safety assessment of chemicals and products in the European Union (EU) is based on decades of practice using primarily animal toxicity studies to model hazardous effects in humans. Nevertheless, there has been a long-standing ethical concern about using experimental animals. In addition, animal models may fail to predict adverse effects in humans. This has provided a strong motivation to develop and use new approach methodologies and other alternative sources of evidence. A key challenge for this is integration of evidence from different sources. This paper is a call for action with regard to development, validation, and implementation of modern safety assessment approaches for human health assessment by means of focused applied research and development with three strands: (a) to improve screening and priority setting, (b) to enhance and partially replace animal studies under the current regulatory schemes and eventually (c) to fully replace animal studies, while achieving at least the same level of protection. For this gradual but systematic replacement of animal studies, a long-term concerted and coordinated effort with clear goals is needed at EU level, as a societal and political choice, to plan and motivate research and innovation in regulatory safety assessment.

From Elsevier via Jisc Publications Router ; History: accepted 2020-11-24, epub 2020-12-03, issue date 2021-02-28 ; Article version: VoR ; Publication status: Published ; Funder: ITF; FundRef: https://doi.org/10.13039/501100010428 ; Safety assessment of chemicals and products in the European Union (EU) is based on decades of practice using primarily animal toxicity studies to model hazardous effects in humans. Nevertheless, there has been a long-standing ethical concern about using experimental animals. In addition, animal models may fail to predict adverse effects in humans. This has provided a strong motivation to develop and use new approach methodologies and other alternative sources of evidence. A key challenge for this is integration of evidence from different sources. This paper is a call for action with regard to development, validation, and implementation of modern safety assessment approaches for human health assessment by means of focused applied research and development with three strands: (a) to improve screening and priority setting, (b) to enhance and partially replace animal studies under the current regulatory schemes and eventually (c) to fully replace animal studies, while achieving at least the same level of protection. For this gradual but systematic replacement of animal studies, a long-term concerted and coordinated effort with clear goals is needed at EU level, as a societal and political choice, to plan and motivate research and innovation in regulatory safety assessment.

Most of the discourse in the area of peer review takes place within the context of the assessment of papers for inclusion in scientific journals. There is a need to explore the use of peer review within the very specific context of the work of EU agencies providing scientific advice and technical support and identify the specific challenges of utilising peer review in this environment. This paper provides a reflection on the key principles applicable to the use of peer review approaches within the context of such agencies. It differs in a number of ways from the classical peer review in academic publishing. This reflection is also intended to contribute to an on-going debate on developments taking place within the broader scientific community in relation to peer review. ; The European Parliament and the Council of the European Union (EU) set up a number of decentralised Agencies to carry out specific legal, technical or scientific tasks within the EU. In 2013, the Heads of EU Agencies Network decided to set up a specialised sub-network of EU Agencies tasked to provide scientific and technical advice to EU Institutions, Member States and other relevant EU-policy makers. It is called EU Agencies Network on Scientific Advise (EU-ANSA).