Suchergebnisse

31 slides.-- Presentation delivered within the third webinar in the Autumn 2021 series, full programme and session recording available at https://eurocris.org/autumn-2021-series-eurocris-webinars. ; The presentation, jointly delivered by members of the Flemish Government Department of Economy, Science and Innovation and the ECOOM at Hasselt University, describes the ongoing process for the inclusion of data on research infrastructures into the regional Flanders Research Information Space (FRIS) regional CRIS. The scope of the initiative and the metadata model used to capture this additional piece of research information are outlined and some examples are shown. Future plans around this development involve offering a visualisation of what projects make use of the infrastructure and what publications are the result of data created via a certain piece of research equipment or facility.

Background: 'Compassionate use' programmes allow medicinal products that are not authorised, but are in the development process, to be made available to patients with a severe disease who have no other satisfactory treatment available to them. We sought to understand how such programmes are regulated in ten European Union countries. Methods: The European Clinical Research Infrastructures Network (ECRIN) conducted a comprehensive survey on clinical research regulatory requirements, including questions on regulations of 'compassionate use' programmes. Ten European countries, covering approximately 70% of the EU population, were included in the survey (Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and the UK). Results: European Regulation 726/2004/EC is clear on the intentions of 'compassionate use' programmes and aimed to harmonise them in the European Union. The survey reveals that different countries have adopted different requirements and that 'compassionate use' is not interpreted in the same way across Europe. Four of the ten countries surveyed have no formal regulatory system for the programmes. We discuss the need for 'compassionate use' programmes and their regulation where protection of patients is paramount. Conclusions: 'Compassionate use' is a misleading term and should be replaced with 'expanded access'. There is a need for expanded access programmes in order to serve the interests of seriously ill patients who have no other treatment options. To protect these patients, European legislation needs to be more explicit and informative with regard to the regulatory requirements, restrictions, and responsibilities in expanded access programmes.

International audience ; BACKGROUND: 'Compassionate use' programmes allow medicinal products that are not authorised, but are in the development process, to be made available to patients with a severe disease who have no other satisfactory treatment available to them. We sought to understand how such programmes are regulated in ten European Union countries. METHODS: The European Clinical Research Infrastructures Network (ECRIN) conducted a comprehensive survey on clinical research regulatory requirements, including questions on regulations of 'compassionate use' programmes. Ten European countries, covering approximately 70% of the EU population, were included in the survey (Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and the UK). RESULTS: European Regulation 726/2004/EC is clear on the intentions of 'compassionate use' programmes and aimed to harmonise them in the European Union. The survey reveals that different countries have adopted different requirements and that 'compassionate use' is not interpreted in the same way across Europe. Four of the ten countries surveyed have no formal regulatory system for the programmes. We discuss the need for 'compassionate use' programmes and their regulation where protection of patients is paramount. CONCLUSIONS: 'Compassionate use' is a misleading term and should be replaced with 'expanded access'. There is a need for expanded access programmes in order to serve the interests of seriously ill patients who have no other treatment options. To protect these patients, European legislation needs to be more explicit and informative with regard to the regulatory requirements, restrictions, and responsibilities in expanded access programmes.

International audience ; BACKGROUND: 'Compassionate use' programmes allow medicinal products that are not authorised, but are in the development process, to be made available to patients with a severe disease who have no other satisfactory treatment available to them. We sought to understand how such programmes are regulated in ten European Union countries. METHODS: The European Clinical Research Infrastructures Network (ECRIN) conducted a comprehensive survey on clinical research regulatory requirements, including questions on regulations of 'compassionate use' programmes. Ten European countries, covering approximately 70% of the EU population, were included in the survey (Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and the UK). RESULTS: European Regulation 726/2004/EC is clear on the intentions of 'compassionate use' programmes and aimed to harmonise them in the European Union. The survey reveals that different countries have adopted different requirements and that 'compassionate use' is not interpreted in the same way across Europe. Four of the ten countries surveyed have no formal regulatory system for the programmes. We discuss the need for 'compassionate use' programmes and their regulation where protection of patients is paramount. CONCLUSIONS: 'Compassionate use' is a misleading term and should be replaced with 'expanded access'. There is a need for expanded access programmes in order to serve the interests of seriously ill patients who have no other treatment options. To protect these patients, European legislation needs to be more explicit and informative with regard to the regulatory requirements, restrictions, and responsibilities in expanded access programmes.

"The purpose of this report is to identify how to better meet the needs of scientists and take into account their concerns around the use of economic and social data at the European level without compromising or neglecting the legitimate needs and justified concerns of European policy makers." [author's abstract]

The paper outlines a model for eResearch infrastructure designed to support collaborative and problem-based research comprising partners and stakeholders from various disciplines as well as government, industry and community-based organisations. Its implementation on a Fedora-based repository system which aggregates, stores, articulates relationships between, and disseminates resources associated with Australian social science research in HIV and related diseases is demonstrated. The model has been developed to bridge the gap between eResearch infrastructure capabilities and established collaborative research practice in various disciplinary fields. Underpinning the design is the proposition that eResearch facilities will be optimally used if they fit seamlessly with existing workflows and practices of researchers, and that alignment of research with policy and practice is best achieved if collaborators are able to access and share resources in a timely and efficient manner. The open Fedora-based repository contains metadata and digital objects for research and policy publications, conference presentations, health promotion campaign resources and media reportage relating to Australian social and policy research in HIV and related diseases. The presentation provides an overview of the content model, including methods for identifying and displaying relationships and for aggregating material in the repository. The implementation outlined in the paper advances significant Australian social and policy research by providing an integrated research facility for the curation, sharing, re-use and exchange of resources required by academic, government and community-based partners throughout the research process.

In this article, we investigate the making of research infrastructures. Our aim is to identify the relevant context factors, actor constellations, organizational settings, and strategies for a mere service to become an actual infrastructure. To this end, we conducted 36 case studies of non-commercial and commercial research services. Our research sheds light on the motivations and logics behind infrastructure development and the reasons why not every service succeeds in becoming one. We believe that the results of this study are therefore of practical relevance, especially for persons and organizations that want to create and sustain research infrastructured.

AbstractThe goal of this paper is to investigate the complementarity of three types of additionalities: input (growth of R&D investments), behavioral (changes in the internal processes of the entity), and output (leveraging social or private returns), occurring as the result of the 7th Framework Programme and Horizon 2020 European Union funds part INFRA. The empirical contribution is based on results of self‐created questionnaires conducted in 2016 with the use of CATI/CAWI on the unique sample of N = 401 users of European Union research infrastructures from 32 countries. We create a Behavioral Additionality Index (BAI), which is a measurement tool that combines eight types (scale, scope, cognitive capacity, challenge, network, follow‐up, management, and acceleration) of behavioral additionalities. Based on the results of a logistic regression, we find that there is a positive relationship between input and behavioral additionality, as well as between behavioral additionality and output additionality. This last link, however, is not shown to be strengthened by input additionality. No significant differences in the level of the BAI were found between EU countries based on their level of innovativeness as measured by the Summary Innovation Index (SII), although we can observe that less developed EU countries, as well as on non‐EU countries, have higher BAI scores compared to developed ones. The overall results lead to the conclusion that the evaluation of public financial support has to be conducted not only for input, behavioral, and output additionalities separately, but must also take into account their complementarity—with its major focus on the behavioral aspects of this effect.

open ; 17 ; Funding text The development of the EURYBIA concept and its preliminary design have been supported by EUMETSAT and the European Union through project Preliminary Design of the Copernicus Ocean Colour Vicarious Calibration under contract EUM/CO/18/4600002161/EJK. MarONet will be supported by NASA, while MOBY-Refresh, on which the optical system is based, is supported by NOAA. ; In the context of the Copernicus Program, EUMETSAT prioritizes the creation of an ocean color infrastructure for system vicarious calibration (OC-SVC). This work aims to reply to this need by proposing the European Radiometry Buoy and Infrastructure (EURYBIA). EURYBIA is designed as an autonomous European infrastructure operating within the Marine Optical Network (MarONet) established by University of Miami (Miami, FL, USA) based on the Marine Optical Buoy (MOBY) experience and NASA support. MarONet addresses SVC requirements in different sites, consistently and in a traceable way. The selected EURYBIA installation is close to the Lampedusa Island in the central Mediterranean Sea. This area is widely studied and hosts an Atmospheric and Oceanographic Observatory for long-term climate monitoring. The EURYBIA field segment comprises off-shore and on-shore infrastructures to manage the observation system and perform routine sensors calibrations. The ground segment includes the telemetry center for data communication and the processing center to compute data products and uncertainty budgets. The study shows that the overall uncertainty of EURYBIA SVC gains computed for the Sentinel-3 OLCI mission under EUMETSAT protocols is of about 0.05% in the blue-green wavelengths after a decade of measurements, similar to that of the reference site in Hawaii and in compliance with requirements for climate studies. ; open ; Liberti G.L.; D'Alimonte D.; di Sarra A.; Mazeran C.; Voss K.; Yarbrough M.; Bozzano R.; Cavaleri L.; Colella S.; Cesarini C.; Kajiyama T.; Meloni D.; Pomaro A.; Volpe G.; Yang C.; Zagolski F.; Santoleri R. ; Liberti, G. L.; ...

Europe's networked societies of today are shaped by a growing interconnection in almost all areas of life. The complexity of our infrastructures and the concurrent accessibility to means of destruction by terrorist groups and individual perpetrators call for innovative security solutions. However, such evolving innovations inevitably raise fundamental questions of concern in our societies. How do we balance the imperatives of securing our citizens and infrastructures on the one hand, and of protecting of our sacredly held civil liberties on the other? The topical network 'Safety and Security' of acatech - the German Academy of Science and Engineering - invited experts from the science academies of various European countries to share their perspectives on security research and the aspect of safety during a two-day workshop hosted by the Fraunhofer Institute for High-Speed Dynamics, Ernst-Mach-Institut in March 2010. This publication is a compilation of contributions made during the workshop.

Extended abstract presented at the CRIS2022 conference in Dubrovnik.-- Event programme available at https://cris2022.srce.hr/#section-program ; 12 slides.-- Presentation delivered within the session "Discussing PID infrastructure" ; The registration of research infrastructures is an integral part of the R&D information system. Its development at national level follows from EU activities in this area. It is based primarily on the documents of the European Strategy Forum on Research Infrastructures (ESFRI) followed by national documents formulating policy aimed at the development and use of research infrastructures and their involvement in European and international initiatives.