Search

Since (higher) education is more important than ever in knowledge societies, high priority should be ascribed to quality management in higher education institutions and its effectiveness. However, there is still a lack of systematic evaluation of the latter, particularly analyses which are not restricted to ex-post gathered data and expert assessments. The articles in this special issue contribute to overcome these shortcomings in several ways: One article is reflecting on success factors and un-/intended effects of quality management, another one is analyzing more discoursive ways of evidence-informed guidance of quality management policies which are complementary to rigorous impact studies. Five articles investigate quality management effectiveness by ex-post and simultaneous impact evaluation in European case studies, including assessments of students, teachers, quality managers and leadership. Finally, a SWOT analysis of impact evaluation of quality management in higher education institutions is carried out and suggested as a tool for bridging the notorious gap between methodology and implementation.

The article deals with the experience of the use of the system of internal monitoring of the quality of higher education in UK Universities. There has been analyzed the existing model of the system of higher education monitoring at the level of a higher education institution within the scope of the British higher education model, discovered by a famous American education philosopher P. Monroe. There has been characterized the new document "The UK Quality Code for Higher Education", which regulates the internal procedures of providing and monitoring the quality of UK universities. There have been provided the data of the comparative analysis of the trends of the internal monitoring of the Higher education quality of some UK universities. The monitoring trends, inherent in all higher education institutions, are the reports of external examiners, feedback of the students, reports of the institutional checkups. Other internal monitoring trends depend on the status, mission of an academic institution and are related to the polling of employers, higher education institutions' alumni, analysis of the reports of the experts of the new curricula evaluation boards, etc. There has been analyzed the cyclic model of higher education monitoring in UK universities.

For many years, the European evaluation community did not recognize evaluation standards as a relevant tool for quality assurance. References to the developments in the United States were exceptionally rare in the European evaluation literature during the 1970s and 1980s. One of the first articles on evaluation standards to appear in the European literature was Wolfgang Beywl's discussion of the Evaluation Standards of the Evaluation Research Society and the Standards for Educational Evaluation. Another early example of the standards discussion in Europe was the translation of the ERS Standards into German. In the past decade, however, discussion about evaluation standards has accelerated in Europe. Based on the cultural diversity of the region, national evaluation organizations have taken distinct approaches to activities in the field of quality assurance in evaluation. This article examines the domain of evaluation standards since the beginning of the 1990s in Western Europe. It looks specifically at Switzerland, Germany, France, and the United Kingdom because they are the European front-runners in this domain. Although the focus of this article is on evaluation standards, it also discusses documents with other labels, specifically principles and charters. The argument underlying this decision is twofold. First, despite their names, these documents play similar roles as nominal evaluation standards. Second, in the author's view, their existence has an unavoidable relevance for the future of evaluation standards in Europe. (Contains 2 tables.)

This paper considers the development of intermediary, or buffer, bodies dealing with quality assurance in higher education in Central and Eastern Europe over the past 10 years. It relates these developments to the context of communist-era centralisation and control, and to more recent interventions by international aid agencies. The lessons that such agencies appear to draw from the Western experience of intermediary bodies in higher education are critically examined. Hypotheses intended to explain the development of different approaches to quality assurance in the region are examined, but none are found to be robust. The paper argues that control, rather than quality enhancement, is the dominating concern of the quality assurance agencies throughout the region. It is further argued that it is important for these agencies to adopt more flexible notions of quality related to institutional goals.(Contains 1 table and 2 notes.)

Higher education quality control structures emerging in West European countries are examined, and the current trend toward definition of quality predominantly from one central power center is criticized. Methodological and substantive weaknesses in this system are discussed, and an approach taking into account other interests and perspectives is advocated. (Author/MSE)

European higher education policies that were first developed as an empirical, short-term response to financial difficulties at the start of the decade have now assumed a long-term strategic character that affects the relationships between government and higher education and between society and higher education. (MSE)

Traditional Chinese Medicine (TCM) herbal products are increasingly used in Europe, but prevalent authentication methods have significant gaps in detection. In this study, three authentication methods were tested in a tiered approach to improve accuracy on a collection of 51 TCM plant ingredients obtained on the European market. We show the relative performance of conventional barcoding, metabarcoding and standardized chromatographic profiling for TCM ingredients used in one of the most diagnosed disease patterns in women, endometriosis. DNA barcoding using marker ITS2 and chromatographic profiling are methods of choice reported by regulatory authorities and relevant national pharmacopeias. HPTLC was shown to be a valuable authentication tool, combined with metabarcoding, which gives an increased resolution on species diversity, despite dealing with highly processed herbal ingredients. Conventional DNA barcoding as a recommended method was shown to be an insufficient tool for authentication of these samples, while DNA metabarcoding yields an insight into biological contaminants. We conclude that a tiered identification strategy can provide progressive qualitative and quantitative insight in an integrative approach for quality control of processed herbal ingredients. [ABSTRACT FROM AUTHOR]

Ground-based radar precipitation products typically need adjustment with rain gauge accumulations to achieve a reasonable accuracy. This is certainly the case for the pan-European radar precipitation products. The density of (near) real-time rain gauge accumulations from official networks is often relatively low. Crowdsourced rain gauge networks have a much higher density than conventional ones and are a potentially interesting (complementary) source to merge with radar precipitation accumulations. Here, a 1-year personal weather station (PWS) rain gauge dataset of ∼ 5 min accumulations is obtained from the private company Netatmo over the period 1 September 2019–31 August 2020, which is subjected to quality control using neighbouring PWSs and, after aggregating to 1 h accumulations, using unadjusted radar data. The PWS 1 h gauge accumulations are employed to spatially adjust OPERA radar accumulations, covering 78 % of geographical Europe. The performance of the merged dataset is evaluated against daily and disaggregated 1 h gauge accumulations from weather stations in the European Climate Assessment & Dataset (ECA&D). Results are contrasted to those from an unadjusted OPERA-based radar dataset and from EURADCLIM. The severe average underestimation for daily precipitation of ∼ 28 % from the unadjusted radar dataset diminishes to ∼ 3 % for the merged radar–PWS dataset. A station-based spatial verification shows that the relative bias in 1 h precipitation is still quite variable and suggests stronger underestimations for colder climates. A dedicated evaluation with scatter density plots reveals that the performance is indeed less good for lower temperatures, which points to limitations in observing solid precipitation by PWS gauges. The outcome of this study confirms the potential of crowdsourcing to improve radar precipitation products in (near) real time. [ABSTRACT FROM AUTHOR]

Objective: Studies have found that gut microbiota may be associated with the development of erectile dysfunction (ED); however, the exact link between the two remains unclear. This study aimed to elucidate the relationship between the gut microbiota and the risk of ED from a genetic perspective. Methods: We investigated the relationship between the gut microflora and ED using two-sample Mendelian randomization. GWAS-pooled data for ED were obtained from 223805 participants in Europe. GWAS summary data for ED were obtained from 223805 subjects in Europe and that for the gut microbiota were obtained from 18340 participants in 24 cohorts. We used the inversevariance weighted (IVW) estimator as the primary method for the preliminary analysis, and the MR-Egger, weighted median (WM), simple model, and weighted model as secondary methods. We used Cochrane's Q-test, to detect heterogeneity, MREgger to detect pleiotropy, and the leave-one-out method to test the stability of the MR results. Ultimately, we genetically predicted a causal relationship between 211 gut microbiota and ED. Results: A total of 2818 SNPs associated with gut microflora were screened in the ED correlation analysis based on the assumption of instrumental variables. The results of MR analysis showed a causal relationship between the six gut microbes and ED occurrence. The results of the fixed effects IVW method revealed five gut microflora, including Lachnospiraceae (OR, 1.265; P = 0.008), Lachnospiraceae NC2004 group (OR, 1.188; P = 0.019), Oscillibacter (OR, 1.200; P = 0.015), Senegalimassilia (OR, 1.355; P = 0.002), Tyzzerella3 (OR, 1.133; P = 0.022), to be negatively associated with ED. In addition, the IVW method revealed Ruminococcaceae UCG-013 (OR, 0.827; P = 0.049) to be positively associated with ED. Quality control results showed no heterogeneity or horizontal pleiotropy in the MR analysis (P > 0.05). Conclusions: Six gut microbes were genetically associated with ED; of which, Ruminococcaceae UCG-013 was causally associated with a reduced risk of ED development. Our findings provide a new direction for research on the prevention and treatment of ED; however, the mechanisms and details require further investigation. [ABSTRACT FROM AUTHOR]

Concrete is a mass commodity with more than approx. 250 Mio. batches of concrete being produced every year in Europe alone. Despite this enormous repetition rate, both the quality inspection of the concrete raw materials as well as of the mixed concrete are still primarily batch‐based, relying on manual processes, thus hindering the application of modern process control schemes. The reasons for this lack are on the one hand to be seen in the lack of suitable sensor technologies and on the other hand in missing control algorithms. The paper at hand gives an overview on the current state of the art sensor technologies for both raw material as well as concrete properties measurement. Further, it outlines a pathway towards an online concrete process control. [ABSTRACT FROM AUTHOR]

Today, endovascular treatment (EVT) is the therapy of choice for strokes due to acute large vessel occlusion, irrespective of prior thrombolysis. This necessitates fast, coordinated multi-specialty collaboration. Currently, in most countries, the number of physicians and centres with expertise in EVT is limited. Thus, only a small proportion of eligible patients receive this potentially life-saving therapy, often after significant delays. Hence, there is an unmet need to train a sufficient number of physicians and centres in acute stroke intervention in order to allow widespread and timely access to EVT. To provide multi-specialty training guidelines for competency, accreditation and certification of centres and physicians in EVT for acute large vessel occlusion strokes. The World Federation for Interventional Stroke Treatment (WIST) consists of experts in the field of endovascular stroke treatment. This interdisciplinary working group developed competency – rather than time-based – guidelines for operator training, taking into consideration trainees' previous skillsets and experience. Existing training concepts from mostly single specialty organizations were analysed and incorporated. The WIST establishes an individualized approach to acquiring clinical knowledge and procedural skills to meet the competency requirements for certification of interventionalists of various disciplines and stroke centres in EVT. WIST guidelines encourage acquisition of skills using innovative training methods such as structured supervised high-fidelity simulation and procedural performance on human perfused cadaveric models. WIST multispecialty guidelines outline competency and quality standards for physicians and centres to perform safe and effective EVT. The role of quality control and quality assurance is highlighted. The World Federation for Interventional Stroke Treatment (WIST) establishes an individualized approach to acquiring clinical knowledge and procedural skills to meet the competency requirements for certification of interventionalists of various disciplines and stroke centres in endovascular treatment (EVT). WIST guidelines encourage acquisition of skills using innovative training methods such as structured supervised high-fidelity simulation and procedural performance on human perfused cadaveric models. WIST multispecialty guidelines outline competency and quality standards for physicians and centers to perform safe and effective EVT. The role of quality control and quality assurance is highlighted. The WIST 2023 Guidelines are published simultaneously in Europe (Adv Interv Cardiol 2023). • Widespread and timely interventional stroke treatment requires multiple specialties. • Training requirements for interventional stroke treatment are outlined. • Special emphasis rests on simulator and human cadaver training. • The pathway for an operator to reach WIST certification is specified. [ABSTRACT FROM AUTHOR]

Background and Objectives: There is a need for conversion of SARS‐CoV‐2 serology data from different laboratories to a harmonized international unit. We aimed to compare the performance of multiple SARS‐CoV‐2 antibody serology assays among 25 laboratories across 12 European countries. Materials and Methods: To investigate this we have distributed to all participating laboratories a panel of 15 SARS‐CoV‐2 plasma samples and a single batch of pooled plasma calibrated to the WHO IS 20/136 standard. Results: All assays showed excellent discrimination between SARS‐CoV‐2 seronegative plasma samples and pre‐vaccinated seropositive plasma samples but differed substantially in raw antibody titres. Titres could be harmonized to binding antibody units per millilitre by calibration in relation to a reference reagent. Conclusion: The standardization of antibody quantification is of paramount importance to allow interpretation and comparison of serology data reported in clinical trials in order to identify donor cohorts from whom the most effective convalescent plasma can be collected. [ABSTRACT FROM AUTHOR]

Background: Digital transformation in healthcare and the growth of health data generation and collection are important challenges for the secondary use of healthcare records in the health research field. Likewise, due to the ethical and legal constraints for using sensitive data, understanding how health data are managed by dedicated infrastructures called data hubs is essential to facilitating data sharing and reuse. Methods: To capture the different data governance behind health data hubs across Europe, a survey focused on analysing the feasibility of linking individual-level data between data collections and the generation of health data governance patterns was carried out. The target audience of this study was national, European, and global data hubs. In total, the designed survey was sent to a representative list of 99 health data hubs in January 2022. Results: In total, 41 survey responses received until June 2022 were analysed. Stratification methods were performed to cover the different levels of granularity identified in some data hubs' characteristics. Firstly, a general pattern of data governance for data hubs was defined. Afterward, specific profiles were defined, generating specific data governance patterns through the stratifications in terms of the kind of organization (centralized versus decentralized) and role (data controller or data processor) of the health data hub respondents. Conclusions: The analysis of the responses from health data hub respondents across Europe provided a list of the most frequent aspects, which concluded with a set of specific best practices on data management and governance, taking into account the constraints of sensitive data. In summary, a data hub should work in a centralized way, providing a Data Processing Agreement and a formal procedure to identify data providers, as well as data quality control, data integrity and anonymization methods. [ABSTRACT FROM AUTHOR]

Improvement in the care of patients with metastatic breast cancer (MBC) can only occur if the adequate quality of care is implemented and verified, including access to multidisciplinary, specialised care given in accordance with high-quality guidelines. To this purpose, European Society of Breast Cancer Specialists and the Advanced Breast Cancer Global Alliance joined efforts to develop the first set of quality indicators (QI) specifically for MBC that should be routinely measured and evaluated to ensure that breast cancer centres meet the required standards. A working group of multidisciplinary European experts in breast cancer met to discuss each identified QI, reporting the definition, the minimum and target standard for breast cancer centres to achieve, and the motivation for selection. The level of evidence was determined according to the short version of the United States Agency for Healthcare Research and Quality classification. QI to measure access to and involvement in multidisciplinary and supportive care, appropriate pathological characterisation of disease, systemic therapies and radiotherapy were developed with the consensus of the working group. This is the first effort of a multistep project that aims to have QI for MBC routinely measured and evaluated to ensure that breast cancer centres achieve mandated standards in the care of patients with metastatic disease. • Quality Indicators (QI) for metastatic breast cancer (MBC) care. • QIs are essential to achieve high-quality care for MBC patients. • The breast centre MDT must take care of a minimum number of MBC patients. [ABSTRACT FROM AUTHOR]

Between 2002 and 2016, church attendance and self-attributed religiosity declines linearly, if all countries included in the European Social Survey are taken together. This analysis differentiates within Europe between two ideological and three denominational divides. Two questions are examined. First, is secularization pervasive across these groups? Second, how pervasive does secularization remain as a macro-level trend, when cohort membership and other individual-level qualities are controlled for? We find that the trend in secularization is well-explained by cohort succession in Western as well as in Catholic and Protestant countries. In Eastern Orthodox countries, however, an increase in religiosity is observed, which cannot be explained by individual-level properties. We speculate that it is triggered by a coalition of national churches and political elites. [ABSTRACT FROM AUTHOR]

Due to insufficient quality control during construction, progressive ageing and deterioration of materials, growing traffic loads and additional risks originating from climate change or man‐made hazards, suboptimal maintenance strategies, an increase of risks to the transport infrastructure seems inevitable. Incidents like the collapse of the Morandi Bridge cannot be singled out: in the last two decades, around 40 bridges in Europe have collapsed or got severely damaged. Aiming to ensure the safety of the transport infrastructure through the improvement of maintenance policies across Europe, the European Commission opened the call for the Coordination and Support Action (CSA) "Monitoring and safety of transport infrastructure". The main objective of this Action is to support the preparation of the mandate for CEN standards for maintenance and control of the European transport infrastructure. The execution of this Coordination and Support Action has been assigned to the IM‐SAFE project consortium. This contribution presents the input proposed by the IM‐SAFE project [1] for future European standards for monitoring, data‐informed safety assessment and proactive maintenance policies for bridges and tunnels, considering the integration of digitalization as enabling technology. [ABSTRACT FROM AUTHOR]

This work improves the characterization and knowledge of the surface wind climatology over Europe with the development of an observational database with unprecedented quality control (QC), the European Surface Wind Observational database (EuSWiO). EuSWiO includes more than 3,829 stations with sub‐daily resolution for wind speed and direction, with a number of sites spanning the period of 1880–2017, a few hundred time series starting in the 1930s and relatively good spatial coverage since the 1970s. The creation of EuSWiO entails the merging of eight different data sets and its submission to a common QC. About 5% of the total observations were flagged, correcting a great part of the extreme and unrealistic values, which have a discernible impact on the statistics of the database. The daily wind variability was characterized by means of a classification technique, identifying 11 independent subregions with distinct temporal wind variability over the 2000–2015 period. Significant decreases in the wind speed during this period are found in five regions, whereas two regions show increases. Most regions allow for extending the analysis to earlier decades. Caution in interpreting long‐term trends is needed as wind speed data have not been homogenized. Nevertheless, decreases in the wind speed since the 1980s can be noticed in most of the regions. This work contributes to a deeper understanding of the temporal and spatial surface wind variability in Europe. It will allow from meteorological to climate and climate change studies, including potential applications to the analyses of extreme events, wind power assessments or the evaluation of reanalysis or model‐data comparison exercises at continental scales. [ABSTRACT FROM AUTHOR]

Purpose: The treatment with a cochlear implant (CI) is the gold standard in therapy of patients with profound hearing loss or deafness. Successful hearing rehabilitation with a CI is a complex, multi-stage process. In medicine, "Clinical Practice Guidelines" (CPG) are widely accepted for the standardization of such processes. These are supplemented by medical registries in which data regarding the treatment can be collected and evaluated. The aim of this paper is to identify currently existing CI-related CPGs and registries in Europe. Methods: Between 01/2021 and 06/2021, 42 countries on the European continent, including the United Kingdom, Russia and Turkey, were screened using an internet search (search engine: Google) and a key word search in the Pubmed database. Search terms were the respective country name combined with the following terms: "Cochlear Implant", "CI", "Cochlear implant clinical practice guideline", "CI Guideline", "Cochlear Implant Registry", "CI Registry", "Ear nose throat society". The internet search was conducted in English as well as in the corresponding national language. The objective was to identify a CI-related CPG or registry. Results: A CPG was found in 16 of 42 (38%) countries. In terms of population, this accounts for 645 million out of 838 million people (77%). A registry existed in 4 of the 42 (10%) countries assessed. This corresponds to 102 million out of 838 million (12%) people. In total, 4 out of 42 countries (10%) had both a CPG and a registry. Conclusion: Our work shows numerous efforts in Europe to standardize CI care at the national level. While most people in Europe already live in countries with a CPG, this is not the case for CI registries. European-wide consensus on CPGs or registries does not yet exist. The present study thus provides a first assessment of the distribution of CI-related CPGs and registries. [ABSTRACT FROM AUTHOR]

Cereals are of utmost importance for the nutrition of infants and children, as they provide important nutrients for their growth and development and, in addition, they are easily digestible, being the best choice for the transition from breast milk/infant formula to solid foods. It is well known that children are more susceptible than adults to toxic food contaminants, such as mycotoxins, common contaminants in cereals. Many mycotoxins are already regulated and controlled according to strict quality control standards in Europe and around the world. There are, however, some mycotoxins about which the level of knowledge is lower: the so-called emerging mycotoxins, which are not yet regulated. The current review summarizes the recent information (since 2014) published in the scientific literature on the amounts of mycotoxins in infants' and children's cereal-based food in Europe, as well as their behaviour during digestion (bioaccessibility). Additionally, analytical methods used for mycotoxin determination and in vitro methods used to evaluate bioaccessibility are also reported. Some studies demonstrated the co-occurrence of regulated and emerging mycotoxins in cereal products used in children's food, which highlights the need to adopt guidelines on the simultaneous presence of more than one mycotoxin. Although very little research has been done on the bioaccessibility of mycotoxins in these food products, very interesting results correlating the fiber and lipid contents of such products with a higher or lower bioaccessibility of mycotoxins were reported. LC-MS/MS is the method of choice for the detection and quantification of mycotoxins due to its high sensibility and accuracy. In vitro static digestion models are the preferred ones for bioaccessibility evaluation due to their simplicity and accuracy. [ABSTRACT FROM AUTHOR]

The article reports that the World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) advises the Director-General of WHO in the area of medicines quality assurance. It mentions that the Committee oversees the maintenance of the International Pharmacopoeia and provides guidance for use by relevant WHO units and regulatory authorities in WHO Member States, to ensure standards of quality, safety and efficacy.

Quality control of protein supplements intended for a large audience of consumers such as sportspeople is particularly important. A case study on quality control of dietary supplements containing protein and protein components is presented. The objective of the study was to evaluate the conformity of the quantities of amino acids, essential and branched-chain amino acids, declared on the label through measurements with chromatographic analytical tools. 16 sportspeople supplements from different European countries were tested. Analysis of concentrated whey protein highlighted some differences between the label and what was experimentally determined; in these samples some amino acids (6 amino acids out of 19) exceeded the maximum tolerance (>20%) regulated by the European Commission. To a lesser extent, analysis of the other classes revealed amino acid concentrations that exceeded the maximum analytical tolerance percentage. As regards the essential and branched amino acid supplements, it was seen that the declared quantity conforms with that determined experimentally.

In the present study, credible analytical and numerical models are developed in order to explain the apparent discrepancies in the ratios of static and dynamic deformation models for assessing the quality of mechanical efficiency of transport structures in Central Europe. Through of experience, authors specifically deal with the comparison of two commonly used methods: the dynamic load plate test, known as the lightweight dynamic test and the static plate load test. This paper presents the relevant correlation dependency of the most commonly used quantification characteristics in earthworks quality control. Their correlation was obtained by applying the static theory of impact to earthworks quality control, which allows for the application of several quality control methods, in line with other member states of the European Union, specifically with regard to constructions under various boundary conditions (climate, soil moisture of the specified layer). According to an analysis of the results of comparisons of static and dynamic load tests, analytical and numerical models of the subsoil formed by soils and uncemented structural materials, respectively, the linear calculation usually used in the conditions of Central Europe does not have universal validity. Rather than relying on the analytical and FEM models for the soil, the authors have determined that the above dependence is a power dependence. [ABSTRACT FROM AUTHOR]

Experiences from 30 years of geochemical mapping at the (sub)continental scale in Europe using a wide range of different sample media are reviewed and discussed with a focus on the most recent GEMAS (GEochemical Mapping of Agricultural Soils) project. Comparing results from the different surveys it is possible to come to conclusions as to how geochemical surveys at the continental scale could best be designed. High analytical quality and lowest possible detection limits are key requirements. In Europe good outcomes were achieved with the <2 mm fraction of soil samples and aqua regia extraction. Focus should be on high quality of sampling and analyses and more determined parameters rather than on more samples. The sample density of 1 site/2500 km2 provides a good overview of the processes governing geochemistry at the continental scale. Results should be extensively published by the project team to allow the dataset to be known and utilized by the wider scientific community. Thematic collection: This article is part of the Continental-scale geochemical mapping collection available at: https://www.lyellcollection.org/topic/collections/continental-scale-geochemical-mapping [ABSTRACT FROM AUTHOR]

Quality care in breast cancer is higher if patients are treated in a Breast Center with a dedicated and specialized multidisciplinary team. Quality control is an essential activity to ensure quality care, which has to be based on the monitoring of specific quality indicators. Eusoma has proceeded with the up-dating of the 2017 Quality indicators for non-metastatic breast cancer based on the new diagnostic, locoregional and systemic treatment modalities. To proceed with the updating, EUSOMA setup a multidisciplinary working group of BC experts and patients' representatives. It is a comprehensive set of QIs for early breast cancer care, which are classified as mandatory , recommended , or observational. For the first time patient reported outcomes (PROMs) have been included. As used in the 2017 EUSOMA QIs, evidence levels were based on the short version of the US Agency for Healthcare Research and Quality. This is a set of quality indicators representative for the different steps of the patient pathway in non-metastatic setting, which allow Breast Centres to monitor their performance with referring standards, i.e minimum standard and target. Monitoring these Quality Indicators, within the Eusoma datacentre will allow to have a state of the art picture at European Breast Centres level and the development of challenging research projects. • Set of comprehensive quality indicators in breast cancer care. • Breast Cancer Care quality indicators to monitor Breast Centre performance. • Breast Cancer quality indicators based on the patient pathway. [ABSTRACT FROM AUTHOR]

This publication describes the outcome of a project to develop a replacement European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human tetanus immunoglobulin (TIg) as well as for the World Health Organization (WHO) International Standard (IS) for Tetanus Immunoglobulin, Human. Bulk TIg was kindly provided by a European manufacturer and was used to prepare the candidate standard. The candidate standard was freeze-dried and calibrated in an international collaborative study jointly co-ordinated by the Medicines & Healthcare products Regulatory Agency (MHRA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe). The results of this study show that there was good agreement between laboratories for the potency estimates obtained for the candidate standard relative to the current WHO IS/Ph. Eur. BRP. The study also demonstrated that the candidate standard is suitable for use in Ph. Eur. assays for potency testing of TIg products and there was good agreement in the potency estimates obtained using the different assay methods included in the study. Accelerated degradation studies performed at the MHRA over a period of 4 years suggest that the freeze-dried candidate standard will be very stable. The candidate standard was established as Ph. Eur. BRP for Human tetanus immunoglobulin, batch 2 with an assigned potency of 45 IU/ampoule. The same preparation was also adopted by the WHO Expert Committee on Biological Standardization (ECBS) to serve as the WHO 2 nd IS for Tetanus Immunoglobulin, Human (13/240)., (© Council of Europe 2024.)

There is a significant demand in the molecular biophysics community for robust standard samples. They are required by researchers, instrument developers and pharmaceutical companies for instrumental quality control, methodological development and in the design and validation of devices, diagnostics and instrumentation. To-date there has been no clear consensus on the need and type of standards that should be available and different research groups and instrument manufacturers use different standard systems which significantly hinders comparative analysis. One of the major objectives of the Association of Resources for Biophysical Research in Europe (ARBRE) is to establish a common set of standard samples that can be used throughout the biophysics community and instrument developers. A survey was circulated among ARBRE members to ascertain the requirements of laboratories when using standard systems and the results are documented in this article. In summary, the major requirements are protein samples which are cheap, relatively small, stable and have different binding strengths. We have developed a panel of sdAb's or 'nanobodies' against hen-egg white lysozyme with different binding strengths and suitable stability characteristics. Here we show the results of the survey, the selection procedure, validation and final selection of a panel of nanobody interaction standards. [ABSTRACT FROM AUTHOR]

Background: Because of limitations of transportation imposed by the COVID-19 pandemic, current recommendation calls for cryopreservation of allogeneic stem cell transplants before patient conditioning. A single cell therapy laboratory was selected to function as the central cryopreservation hub for all European registry donor transplants intended for the Australian-Pacific region. We examined properties of these transplants to ascertain how quality is maintained.Methods: We analyzed 100 pandemic-related allogeneic mobilized blood-derived stem cell apheresis products generated at 30 collection sites throughout Europe, shipped to and cryopreserved at our center between April and November of 2020. Products were shipped in the cool, subsequently frozen with DMSO as cryoprotectant. Irrespective of origin, all products were frozen within the prescribed shelf-life of 72 h.Results: Prior to cryopreservation, viable stem cell and leukocyte count according to the collection site and our reference laboratory were highly concordant (r2 = 0.96 and 0.93, respectively) and viability was > 90% in all instances. Median nominal post-thaw recovery of viable CD34+ cells was 42%. Weakly associated with poorer CD34+ cell recovery was higher leukocyte concentration, but not time lag between apheresis or addition of cryopreservant, respectively, and start of freezing. The correlation between pre- and post-thaw CD34+ cell dose was high (r2 = 0.85), hence predictable. Neutrophil and platelet engraftment were prompt with no evidence of dose dependency within the range of administered cell doses (1.31-15.56 × 106 CD34+ cells/kg).Conclusions: General cryopreservation of allogeneic stem cell transplants is feasible. While more than half of the CD34+ cell content is lost, the remaining stem cells ensure timely engraftment. [ABSTRACT FROM AUTHOR]

Individual monitoring of external radiation is an activity usually regulated by national regulatory bodies in most countries. Regulations generally contain technical requirements to be met by the individual monitoring services (IMS), in order to ensure that the measurements are correct and therefore the dosimetry results are reliable. In some countries, the requirements include or even consist of the accreditation of the service according to the standard ISO/IEC 17025: 'General requirements for the competence of testing and calibration laboratories.' It is a fact that accreditation is a growing trend among European IMS as a way to guarantee confidence in their technical competence. The acceptance of the dosimetry results between countries and their indentation in the respective National Dose Registries is facilitated if laboratories conform to the ISO/IEC 17025 standard. In the framework of the activities of EURADOS (European Radiation Dosimetry Group) working group 2 'Harmonization of Individual Monitoring in Europe' and attending to the concern of many European IMS in the process of accreditation, a guide has been prepared. The purpose was to assist and encourage IMS to apply for accreditation and to share the authors' own experience with the process. The guide intends to be a practical reference for IMS on how to interpret and implement the ISO/IEC 17025 requirements to the specific activity of a personal dosimetry service for external radiation, emphasizing those aspects of special interest. It includes examples from dosimetry laboratories already accredited. The major novelties from a new edition of ISO/IEC 17025: 2017 are also identified in the guide. Finally, the guide aims to assist the auditing process, giving examples of auditor's questions and how to show evidence of compliance. The main findings are presented., (© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Based on the data in the Ph. Eur., some other newer pharmacopoeias and published experimental papers propose to revise the text of Ph. Eur. 2.5.8. First, it is necessary to specify which of the electrometric methods should be used to indicate the endpoint of diazotization titrations in Ph. Eur. (preferable potentiometry with a platinum indicating electrode). The amount of potassium bromide in the titration solution may be reduced to 1 g, the cooling of the solution before titration may be omitted from the framework procedure, and it may be specified in individual monographs if necessary to obtain accurate and correct results for some medicines. Diazotization titration can be performed in Ph. Eur. and can also be used to determine the content of some other medicines.

The role of quality infrastructure, i.e., regulation, standardization, metrology, conformity assessment, and accreditation, is analyzed in the general context of socio-technical transformations. Six policy intervention points structure their potential contributions. First, insights from the literature and anecdotal evidence reveal that regulation plays an essential role in niche stimulation, yet standardization is becoming more important for niche acceleration. However, regulation is essential for destabilizing the whole regime but also for addressing possible repercussions. Within the coordination of multi-regime interactions, the consistency of regulations and the interfaces to the other elements of quality infrastructure has to be assured. To tilt the whole landscape, the regulatory framework conditions have to be altered, allowing changes in the directionality of socio-technical systems. Finally, international standards can leverage nationally focused changes of regulations towards the global level. Policy recommendations and limitations conclude the paper. • Elements of quality infrastructure can transform socio-technical systems. • Regulation plays an important role in niche stimulation. • Standardization becomes more important for niche acceleration. • Coordination of all elements of quality infrastructure is needed. [ABSTRACT FROM AUTHOR]

Classical quality control (QC) methods of solar irradiance apply easy-to-implement physical or statistical limits that are incapable of detecting low-magnitude measuring errors due to the large width of the intervals. We previously presented the bias-based quality control (BQC), a novel method that flags samples in which the bias of several independent gridded datasets is larger for consecutive days than the historical value. The BQC was previously validated at 313 European and 732 Spanish stations finding multiple low-magnitude errors (e.g., shadows, soiling) not detected by classical QC methods. However, the need for gridded datasets, and ground measurements to characterize the bias, was hindering the BQC implementation. To solve this issue, we present a free web service, www.bqcmethod.com , that implements the BQC algorithm incorporating both the gridded datasets and the reference stations required to use the BQC across Europe from 1983 to 2018. Users only have to upload a CSV file with the global horizontal irradiance measurements to be analyzed. Compared to previous BQC versions, gridded products have been upgraded to SARAH-2, CLARA-A2, ERA5, and the spatial coverage has been extended to all of Europe. The web service provides a flexible environment that allows users to tune the BQC parameters and upload ancillary rain data that help in finding the causes of the errors. Besides, the outputs cover not only the visual and numerical QC flags but also daily and hourly estimations from the gridded datasets, facilitating the access to raster data. • Automatic visualization of QC results to facilitate error detection. • Users only need to upload a CSV file with ground measurements. • Outputs include point estimations of SARAH-2, CLARA-A2, and ERA5. [ABSTRACT FROM AUTHOR]

• LCI is an effective primary endpoint in the first international phase III clinical trial to report LCI as the primary outcome. • Standard MBW training, certification and quality control is required to incorporate MBW and as an outcome in a large clinical trial. • High MBW test feasibility and sustained collection of good quality data achieved with international collaborative effort. The lung clearance index (LCI), derived from the Multiple Breath Washout (MBW) test, is sensitive to treatment effects and compared with spirometry has higher feasibility in younger children and requires smaller sample sizes. As a result, the LCI has been endorsed by the European CF Society Clinical Trials Network for use as a primary outcome measure in CF clinical trials. Here we describe the implementation of standardised protocols for MBW test performance, data collection and quality control to successfully incorporate LCI as a novel outcome measure in a large multicentre phase III clinical trial. Three regional (North America (NA), Europe (EU), Australia (AUS)) central over-reading centres (CORC) were established to provide a collaborative platform for MBW training, certification and quality control of data. One hundred and thirty-two naïve operators from 53 sites across NA, EU and AUS were successfully trained and certified to perform MBW testing. Incorporation of a re-screening opportunity in the study protocol resulted a final screening feasibility rate of 93%, success remained high throughout the study resulting in an overall feasibility of MBW study data of 88.1% (1107/1257). MBW test acceptability was similar between geographical regions: NA (88%), EU (89%) and AUS (89%). With this approach we achieved high MBW test feasibility and sustained collection of good quality data, demonstrating the utility of LCI as an effective primary endpoint in the first international phase III clinical trial to report LCI as the primary outcome. [ABSTRACT FROM AUTHOR]

Background: Ontologies are widely used across biology and biomedicine for the annotation of databases. Ontology development is often a manual, time-consuming, and expensive process. Automatic or semi-automatic identification of classes that can be added to an ontology can make ontology development more efficient. Results: We developed a method that uses machine learning and word embeddings to identify words and phrases that are used to refer to an ontology class in biomedical Europe PMC full-text articles. Once labels and synonyms of a class are known, we use machine learning to identify the super-classes of a class. For this purpose, we identify lexical term variants, use word embeddings to capture context information, and rely on automated reasoning over ontologies to generate features, and we use an artificial neural network as classifier. We demonstrate the utility of our approach in identifying terms that refer to diseases in the Human Disease Ontology and to distinguish between different types of diseases. Conclusions: Our method is capable of discovering labels that refer to a class in an ontology but are not present in an ontology, and it can identify whether a class should be a subclass of some high-level ontology classes. Our approach can therefore be used for the semi-automatic extension and quality control of ontologies. The algorithm, corpora and evaluation datasets are available at https://github.com/bio-ontology-research-group/ontology-extension. [ABSTRACT FROM AUTHOR]

Background/purpose: A key measure to maintain and improve the quality of healthcare is the formal accreditation of provider units. The European Society of Endocrine Surgeons (ESES) therefore proposes a system of accreditation for endocrine surgical centers in Europe to supplement existing measures that promote high standards in the practice in endocrine surgery. Methods: A working group analyzed the current healthcare situation in the field of endocrine surgery in Europe. Two surveys were distributed to ESES members to acquire information about the structure, staffing, caseload, specifications, and technology available to endocrine surgery units. Further data were sought on tracer diagnoses for quality standards, training provision, and research activity. Existing accreditation models related to endocrine surgery were included in the analysis. Results: The analysis of existing accreditation models, available evidence, and survey results suggests that a majority of ESES members aspire to a two-level model (termed competence and reference centers), sub-divided into those providing neck endocrine surgery and those providing endocrine surgery. Criteria for minimum caseload, number and certification of staff, unit structure, on-site collaborating disciplines, research activities, and training capacity for competence center accreditation are proposed. Lastly, quality indicators for distinct tracer diagnoses are defined. Conclusions: Differing healthcare structures, existing accreditation models, training models, and varied case volumes across Europe are barriers to the conception and implementation of a pan-European accreditation model. However, there is consensus on accepted standards required for accrediting an ESES competence center. These will serve as a basis for first-stage accreditation of endocrine surgery units. [ABSTRACT FROM AUTHOR]

• Inactivated rabies vaccines production use large amounts of laboratory animals. • New in vitro methods for residual live virus assay need to be developed. • Molecular biology methods can help in quantifying residual rabies virus in inactivated vaccines. • RABV duplex RT-qPCR assay is a viable option for replacing in vivo tests during intermediate steps of vaccine manufacturing. Rabies is an infectious viral disease, characterized as a neglected zoonosis, responsible for nearly 60,000 deaths annually. The virus is transmitted mainly by dogs in Africa and Asia, and wildlife in Europe and the Americas, to all mammals' species, causing severe encephalitis almost always fatal after the onset of neurological symptoms. Human rabies can be prevented through extensive vaccination of dogs and pre/post-prophylaxis treatments in humans with inactivated rabies vaccines. The vaccine manufacture involves a series of quality control assays using laboratory animals, which are mandatory to exclude the presence of viable residual virus. The quality controls must be carried out in various steps during the vaccine production, which demands the use of a large number of animals. In this study, we standardized a real-time quantitative RT-PCR duplex assay to be used during intermediate stages of the vaccine production. This assay was done for the quantification of vaccine strain rabies virus, targeting rabies nucleoprotein, and β-actin mRNA of BHK-21 cells as an internal endogenous control. The results showed specific amplification, with the analytical sensitivity ranged from 101 to 106 TCID 50 /mL with high repeatability rate for the quantification of rabies virus in inactivated vaccine samples. Global organizations are engaged to develop new approaches to determine viable residual virus, and this assay can be applied in combination with traditional in vitro methods for the release of intermediate batches of vaccines during the production process, keeping the in vivo tests only for final release. [ABSTRACT FROM AUTHOR]

The revised European Directive from 2013 regarding basic safety standard oblige EU Member States to establish a national action plan regarding the exposure to radon. At the same time, International Atomic Energy Agency started technical projects in order to assist countries to establish and implement national radon action. As a consequence, in recent years, in numerous countries national radon surveys were conducted and action plans established, which were not performed before. In this paper, a qualitative overview of radon surveys performed in Europe is given with a special attention to the qualitative and conceptual description of surveys, representativeness and QA/QC (quality assurance/quality control). • Literature overview of indoor radon surveys performed in Europe. • Analysis of survey design and representativeness of indoor radon surveys. • Analysis of measurement techniques used in indoor radon surveys. • Analysis of sampling procedure, sampling number and type of locations in indoor radon surveys. • Analysis of quality assurance and quality control in indoor radon surveys. [ABSTRACT FROM AUTHOR]

Aims: Statin-related myopathy (SRM), which includes rhabdomyolysis, is an uncommon but important adverse drug reaction because the number of people prescribed statins world-wide is large. Previous association studies of common genetic variants have had limited success in identifying a genetic basis for this adverse drug reaction. We conducted a multi-site whole-exome sequencing study to investigate whether rare coding variants confer an increased risk of SRM. Methods and results: SRM 3–5 cases (N = 505) and statin treatment-tolerant controls (N = 2047) were recruited from multiple sites in North America and Europe. SRM 3–5 was defined as symptoms consistent with muscle injury and an elevated creatine phosphokinase level >4 times upper limit of normal without another likely cause of muscle injury. Whole-exome sequencing and variant calling was coordinated from two analysis centres, and results of single-variant and gene-based burden tests were meta-analysed. No genome-wide significant associations were identified. Given the large number of cases, we had 80% power to identify a variant with minor allele frequency of 0.01 that increases the risk of SRM 6-fold at genome-wide significance. Conclusions: In this large whole-exome sequencing study of severe statin-related muscle injury conducted to date, we did not find evidence that rare coding variants are responsible for this adverse drug reaction. Larger sample sizes would be required to identify rare variants with small effects, but it is unclear whether such findings would be clinically actionable. [ABSTRACT FROM AUTHOR]

Chemical Transport Models (CTM) and air quality measurements provide complementary information on atmospheric composition. Their melding improves accuracy, important for air quality studies and to support policy makers. An assimilation scheme based on 3D-Var / OI has been developed and implemented for the CTM FARM, core of the MINNI modelling system, which is operational within the regional Copernicus Atmospheric Monitoring Service (CAMS). The scheme assimilates O 3 , NO 2 , CO, SO 2 , PM 10 and PM 2.5 concentration observations from ground stations and it can be adapted to other pollutants. Two assimilation experiments are validated with independent observations, and compared with a simulation and with CAMS Validated ReAnalysis (VRA) for the year 2018 over the European domain. Both experiments expectedly improve on the free simulation control run, and their scores are consistent with those of the VRA ensemble. In the second experiment the Spatial Consistency Test (SCT) is employed to precisely pinpoint observations affected by large errors and to prevent their assimilation. This significantly improves results that compare very well with the reanalysis ensemble median. • An assimilation scheme based on 3Dvar/O.I. is implemented on CTM FARM model. • Results are consistent with CAMS ensemble reanalysis. • Spatial Consistency Test improves model skill scores. • Advance quality control of assimilated observations improves model estimates. [ABSTRACT FROM AUTHOR]

The European Human Biomonitoring Initiative (HBM4EU) ran from 2017 to 2022 with the aim of advancing and harmonizing human biomonitoring in Europe. More than 40,000 analyses were performed on human samples in different human biomonitoring studies in HBM4EU, addressing the chemical exposure of the general population, temporal developments, occupational exposure and a public health intervention on mercury in populations with high fish consumption. The analyses covered 15 priority groups of organic chemicals and metals and were carried out by a network of laboratories meeting the requirements of a comprehensive quality assurance and control system. The coordination of the chemical analyses included establishing contacts between sample owners and qualified laboratories and monitoring the progress of the chemical analyses during the analytical phase, also addressing status and consequences of Covid-19 measures. Other challenges were related to the novelty and complexity of HBM4EU, including administrative and financial matters and implementation of standardized procedures. Many individual contacts were necessary in the initial phase of HBM4EU. However, there is a potential to develop more streamlined and standardized communication and coordination in the analytical phase of a consolidated European HBM programme. [Display omitted] [ABSTRACT FROM AUTHOR]

Tuber brumale is a European edible truffle species that is often viewed as a contaminant in truffle orchards, as it visually resembles more valuable black truffles such as T. melanosporum, but differs in aroma and flavor and sells for a much lower price. Although T. brumale is not native to or intentionally cultivated in North America, it was reported to have been accidently introduced into British Columbia in 2014 and North Carolina in 2020. However, in winter of 2021, various truffle orchards in eastern North America produced truffles that differed from the anticipated harvest of T. melanosporum. Molecular analysis of these specimens confirmed T. brumale truffle fruiting bodies from ten orchards distributed across six eastern USA states. Phylogenetic analysis of nuclear ribosomal ITS and 28S DNA sequences indicated that all samples belong to the T. brumale A1 haplogroup, the genetic subgroup of T. brumale that is more common in western Europe. This pattern of widespread fruiting of T. brumale in North American truffle orchards is likely the result of T. brumale being introduced in the initial inoculation of trees used as hosts in T. melanosporum truffle cultivation. We review other examples of introduced non-target truffle species and strategies for limiting their impact on truffle cultivation., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

The 2009 influenza pandemic highlighted challenges for vaccine post-marketing monitoring in Europe, particularly the need to have appropriate infrastructures to strengthen public-private collaborations (PPCs) with suitable processes to improve stakeholder interactions and collection and analysis of safety and effectiveness data. The ADVANCE consortium comprises public and private stakeholders who have worked together to build and test new system components for vaccine post-marketing projects, one component being a governance framework for efficient, transparent and trustworthy PPCs. Based on the results of a landscape analysis and screening of formalised existing governance structures, we identified the elements of a governance framework and developed recommendations to support stakeholders willing and able to implement collaborative projects. These proposals and their implementation were discussed by 70 experts during a workshop to gain from their experience. We identified core governance principles and defined five fundamental functions (decision-making, scientific advice, quality control and audit, implementation and management, and financial administration) that can be attributed to individual partner organisations or to a committee with representatives from more than one partner organisation. We propose a generic governance model with options for its adaptation to specific contexts and projects. The advantages and disadvantages of PPCs were also examined. Stakeholders' concerns (e.g. scientific integrity and public trust) were addressed through recommendations about transparent decision-making rules and conflict of interest management. No one-size-fits-all solution for PPC governance exists but our recommendations could be used to set-up a tailored-made and fully transparent governance structure supporting collaborative projects in the European vaccine post-marketing environment. To allow the rapid establishment of robust projects, the next steps will involve this guidance being used by real-world collaborations to assess what works and what does not work and what added-value can be obtained from these collaborations. [ABSTRACT FROM AUTHOR]

Recent technological advances in representation of processes in numerical climate models have led to skillful predictions, which can consequently increase the confidence of hydrological predictions and usability of hydroclimatic services. Given that many water‐related stakeholders are affected by seasonal hydrological variations, there is a need to manage such variations to their advantage through better understanding of the drivers that influence hydrological predictability. Here we analyze the seasonal forecasts of streamflow volumes across about 35,400 basins in Europe, which lie along a strong gradient in terms of climatology, scale, and hydrological regime. We then link the seasonal volumetric errors to various physiographic‐hydroclimatic descriptors and meteorological biases in order to identify the key drivers controlling predictability. Streamflow volumes over Europe are well predicted, yet with some geographic and seasonal variability; however, the predictability deteriorates with increasing lead time particularly in the winter months. Nevertheless, we show that the forecast quality is well correlated to a set of descriptors, which vary depending on the initialization month. The forecast quality of seasonal streamflow volumes is strongly dependent on the basin's hydrological regime, with limited predictability in relatively flashy basins. On the contrary, snow and/or baseflow dominated regions with long recessions show high streamflow predictability. Finally, climatology and precipitation forecast biases are also related to streamflow predictability, highlighting the importance of developing robust bias adjustment methods. Overall, this investigation shows that the seasonal streamflow predictability can be clustered, and hence regionalized, based on a priori knowledge of local hydroclimatic conditions. Plain Language Summary: Hydrological information for the months ahead is of great value to existing decision‐making practices, particularly to those affected by the vagaries of the climate and who would benefit from better understanding and managing climate‐related risks. Currently, there is limited knowledge of the factors controlling the quality of the seasonal streamflow forecasts. We analyze such forecasts over Europe and link their predictability to basin descriptors and meteorological biases. This allows the identification of the key drivers along a strong hydroclimatic gradient. The seasonal streamflow predictability varies geographically and seasonally with acceptable values for the first lead months. Predictability deteriorates with increasing lead time particularly in the winter months. The hydrological regime is strongly linked to the forecast quality, with quickly reacting basins showing low values. Basin climatology and precipitation forecast biases are also related to the predictability of streamflow. Key Points: Forecast quality of seasonal streamflow volume varies geographically and seasonally, while streamflow predictability can be regionalizedStreamflow predictability is strongly dependent on the basin's hydrological regime, climatology, and precipitation forecast biasesPredictability is higher in river systems of long streamflow memory than in systems immediately responding to the precipitation signal [ABSTRACT FROM AUTHOR]

Objectives: We present the results of two European external quality assessments (EQAs) conducted in 2014 and 2016 under the auspices of the Study Group on Staphylococci and Staphylococcal Infections of ESCMID. The objective was to assess the performance of participating centres in characterizing Staphylococcus aureus using their standard in-house phenotypic and genotypic protocols.Methods: A total of 11 well-characterized blindly coded S. aureus (n = 9), Staphylococcus argenteus (n = 1) and Staphylococcus capitis (n = 1) strains were distributed to participants for analysis. Species identification, MIC determination, antimicrobial susceptibility testing, antimicrobial resistance and toxin gene detection and molecular typing including spa typing, SCCmec typing and MLST were performed.Results: Thirteen laboratories from 12 European countries participated in one EQA or both EQAs. Despite considerable diversity in the methods employed, good concordance (90%-100%) with expected results was obtained. Discrepancies were observed for: (i) identification of the S. argenteus strain; (ii) phenotypic detection of low-level resistance to oxacillin in the mecC-positive strain; (iii) phenotypic detection of the inducible MLSB strain; and (iv) WGS-based detection of some resistance and toxin genes.Conclusions: Overall, good concordance (90%-100%) with expected results was observed. In some instances, the accurate detection of resistance and toxin genes from WGS data proved problematic, highlighting the need for validated and internationally agreed-on bioinformatics pipelines before such techniques are implemented routinely by microbiology laboratories. We strongly recommend all national reference laboratories and laboratories acting as referral centres to participate in such EQA initiatives. [ABSTRACT FROM AUTHOR]

Abstract: The European Society of Breast Cancer Specialists (EUSOMA) requires that the breast centers' core team includes a trained person responsible for data collection and analysis. We addressed a questionnaire to the data managers of the EUSOMA breast centers network in order to acquire information with regard to their education, training, role, activity, recognition, and satisfaction. Breast centers' data managers are highly educated individuals with a variety of backgrounds carrying out, more frequently part‐time and as temporary employees, a job for which they received little specific training. These findings support the importance of defining a core curriculum and a training program. [ABSTRACT FROM AUTHOR]

European Directive 2004/24/EC introduced a simplified registration for traditional herbal medicinal products and a mandate to establish an expert committee at the European Medicines Agency (EMA) to facilitate national procedures via European Union (EU) harmonised standards. Its aim was to contribute to public health with guarantees on quality, safety and appropriate patient information for traditional products that do not require clinical efficacy data compared with new pharmaceutical developments. In this article we review the implementation of the legislation, including the number and type of (i) monographs and guidance documents established at the EMA, and (ii) licensed herbal medicinal products in the EU Member States. Both datasets were compared in order to examine the use of regulatory pathways and harmonised standards. Between 2004 and the end of 2016, about 190 herbal substances have been assessed at European level, leading to 150 monographs, 13 list entries and 19 public statements, as well as general guidance. During that period, 1719 registrations and 859 authorisations have been granted in the EU Member States. Monographs are now largely used in national, and increasingly in European, procedures. Monographs and nationally approved products match principally as regards the main herbal substances and their uses. Specific features of herbal medicinal products are also presented and achievements and remaining gaps are discussed. We conclude that coordinated standards for use in individual product licensing provide a firm reference for assessors and companies, and a reliable evaluation of safe use for patients. After successful establishment of monographs and guidelines, and authorisation of products for the main plants used in Europe, future activities now shift to monograph updates and the evaluation of combinations and substances from non-European traditions. [ABSTRACT FROM AUTHOR]