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The process of reviewing the European pharmaceutical legislation resulted in a codex, which contains two new instruments related to marketing authorisation of biological medicines: Plasma Master File (PMF) and Vaccine Antigen Master File (VAMF). In the manufacture of plasma derivatives (e. g. coagulation factors, albumin, immunoglobulins), usually the same starting material, i. e. a plasma pool, is used for several products. In the case of vaccines, the same active substance, i.e. vaccine antigen, may be included in several combination vaccine products. The intention behind the introduction of PMF and VAMF was to avoid unnecessary and redundant documentation, and to improve and harmonise assessment by means of procedures for certification of master files on the community level.

Much recent research stresses the increasing relevance of international organisations (IOs) for national education policymaking. Yet, IOs' curriculum recommendations have remained largely out of scope, although they provide a forceful example of 'soft' governance. Based on a content analysis of 83 documents from 42 inter/-nongovernmental, global and regional organisations involved in international education networks between 1990 and 2015, this paper identifies an expansive field of IOs directing growing attention to such curricular issues as student needs, educational goals and content, as well as issues of teaching and learning. In line with much cross-national curriculum research, analysis provides evidence for the trend towards a global curriculum model stressing empowerment, individual agency and psychosocial development. The article argues that the strong focus on human capabilities and human capital in IOs' curriculum policies reflects wider cultural transformations in contemporary world society. The article concludes by arguing for an expanded analytical scope of IOs' educational work and a reconsideration of causal explanations in curriculum theories.

Introduction: Over the last decade, the emergence and spread of personalized medicine (PM) have defined a substantial revolution in healthcare. In principle, healthcare system sustainability is challenged by the investments required for research and development, as well as the adoption of PM techniques in routine clinical care. The "Integrating China in the International Consortium for Personalized Medicine" (IC2PerMed) EU-funded project aims to integrate China into the "International Consortium for Personalized Medicine" (ICPerMed). IC2PerMed aims to align the EU and China's research agendas in this field to enable a swift development of approaches in the EU and China with strong leverage upon EU-Chinese collaborations. Methods: Within this project, we first mapped relevant policies on PM in both the EU and China, and then we involved European and Chinese experts in PM in workshops and Delphi surveys in order to identify relevant priorities for the implementation of PM in sustainable healthcare. Results: As a result of this process, we identified nine overarching priorities, each addressing specific aspects of the sustainability of healthcare systems and PM implementation, with the main goal of supporting policymakers in integrating PM approaches in the EU and China. Discussion/conclusion: The implementation of PM in health systems is appealing in terms of improved accuracy in diagnostics, treatment, and prevention of disease, as well as reduction of the side effects resulting from inefficient use of drugs. Research, development, and implementation of needed techniques require time and resources that can slow the adoption of PM in healthcare systems. The nine priorities we identified address some of the most critical points, trying to lay the foundations for a comprehensive approach. [ABSTRACT FROM AUTHOR]

Structured reporting in radiology continues to hold substantial potential to improve the quality of service provided to patients and referring physicians. Despite many physicians' preference for structured reports and various efforts by radiological societies and some vendors, structured reporting has still not been widely adopted in clinical routine. While in many countries national radiological societies have launched initiatives to further promote structured reporting, cross-institutional applications of report templates and incentives for usage of structured reporting are lacking. Various legislative measures have been taken in the USA and the European Union to promote interoperable data formats such as Fast Healthcare Interoperability Resources (FHIR) in the context of the EU Health Data Space (EHDS) which will certainly be relevant for the future of structured reporting. Lastly, recent advances in artificial intelligence and large language models may provide innovative and efficient approaches to integrate structured reporting more seamlessly into the radiologists' workflow. The ESR will remain committed to advancing structured reporting as a key component towards more value-based radiology. Practical solutions for structured reporting need to be provided by vendors. Policy makers should incentivize the usage of structured radiological reporting, especially in cross-institutional setting. Critical relevance statement Over the past years, the benefits of structured reporting in radiology have been widely discussed and agreed upon; however, implementation in clinical routine is lacking due—policy makers should incentivize the usage of structured radiological reporting, especially in cross-institutional setting. Key points 1. Various national societies have established initiatives for structured reporting in radiology. 2. Almost no monetary or structural incentives exist that favor structured reporting. 3. A consensus on technical standards for structured reporting is still missing. 4. The application of large language models may help structuring radiological reports. 5. Policy makers should incentivize the usage of structured radiological reporting. [ABSTRACT FROM AUTHOR]

Bisphenol A (BPA) is an industrial chemical that is widely used in various industrial applications. It has concerns in its use as a color developer in thermal paper receipts since it is identified as an endocrine disruptor and causes hormonal disturbances. In this study, thirty thermal paper receipt samples were randomly collected from various locations in Sharjah, United Arab Emirates and analyzed using high performance liquid chromatography–mass spectrometry. Sixty percent (60%) of receipt samples showed BPA levels above the acceptable limit (200 ng/mg) set by the European Union (EU) for thermal papers. On the other hand, 40% of the samples reported very low BPA levels (< 0.02 ng/mg). However, estimated weight adjusted daily intakes (EDI) ranged between 8.22 ×10−11 and 0.000812 μg/kg bw/day for the general population, and between 7.89×10−9 and 0.0681 μg/kg bw/day for the occupationally exposed cashiers. Thus, all calculated EDIs were below the European Food Safety Authority Tolerable Daily Intake (4 μg/kg·bw/day) and the provisional Health Canada Tolerable Daily Intake (25 ug/kg bw/day) under varying paper-to-skin transfer coefficients and absorption fractions. Nevertheless, due to its health effects and recent legal restrictions by EU, the occurrence of co-exposure to dietary and non-dietary sources should be considered in the health risk assessment of Bisphenol A, mainly for people with frequent occupational exposure to thermal paper, and especially with the increased use of sanitizers. The current study is a first within the UAE context in relation to BPA in thermal paper receipts, thus its significance especially with the recent EU enforcement of BPA limits in paper receipts. The study highlights that proper policies as well as education and awareness may assist in limiting transdermal BPA exposure for the general and occupationally exposed populations. [ABSTRACT FROM AUTHOR]

This study examines the spillover of pollution among the 26 European Union (EU) countries from 1995 to 2020. In order to quantify pollution spillovers among the countries, we estimated the Environmental Kuznets Curve (EKC) using spatial econometric methods. Our research is unique in that it investigates ecological footprint spillovers for EU countries. This study also considers the direct and indirect effects of renewable and fossil energy consumption and globalization on environmental degradation in EU countries. The empirical results favor the validity of the EKC hypothesis. Our results support the presence of positive and significant ecological footprint spillovers among EU countries. Our spatial estimates also reveal the significant spillover impact of explanatory variables on the ecological footprint. The ecological footprint of the local country is declining owing to the consumption of renewable energy in neighboring countries. Furthermore, the fossil energy consumption of the local and neighboring countries has a positive impact on the ecological footprint. Evidence obtained from our spatial estimates provides useful insights to policymakers in developing appropriate environmental policies to combat climate change., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

The "Memorandum on Lifelong Learning" was launched in October 2000 by the European Commission and has been debated ever since in all member states of the European Union, leading to the publication of a follow-up document in 2001 which promoted a "European area of lifelong learning". The "Memorandum" was a unique document in terms of both form and content, and its outcome and immediate impact were remarkable. But what is the long-term effect of this document, considering policymaking processes and scholarly debates in various EU member states and beyond? The authors of this article aim to answer this question by highlighting the "Memorandum's" "key messages" and analysing how it is referenced in academic papers and publications. Their main findings confirm the "Memorandum's" significant impact, including a long-term one, particularly in raising awareness of the importance of adult education in the political debate. Despite a decrease in explicit references to the document in policy papers over the past ten years, other more recent references to the "Memorandum" can still be identified in the latest policy documents and academic debates. Scholarly papers are particularly interested in critical content analysis, pointing out the strengths and limitations of the "Memorandum" and its follow-up document. During the past decade, the academic debate has become more active than in the first ten years since the "Memorandum's" publication, demonstrating its long-term impact on various sectors in the field of lifelong learning, even outside Europe.

In the European Union (EU), Regulation (EC) 1935/2004 provides a harmonized legal EU framework and sets out the general principles for safety and inertness for all Food Contact Materials (FCMs) and Food Contact Articles. From a food safety point of view, however, specific EU legislation for paper and cardboard FCMs is lacking, while at Member State level, national legislation differs among countries. More than 11,000 chemicals have been identified in all types of FCMs, most of them without any information on toxicity or migration potential from FCM to food. The present review shows a wide variability of protocols, approaches, and conditions used in scientific studies, which are difficult to compare. In this regard, procedures and conditions laid down in EU legislation for plastics and European Standards (EN protocols) may serve as a good basis for the future sample preparation procedures in the framework of paper and cardboard FCMs safety assessment. Challenges on sample preparation procedures are presented involving the interlinked steps of sample preparation, conditions used and their impact in chemical analysis and in vitro bioassay testing. Currently, there is no general consensus on the criteria for structuring, evaluating, and tuning sample preparation procedures for paper and cardboard FCMs. For this purpose, a set of modified criteria and a decision tree are proposed based on the literature. Along this, mass transfer processes occurring in paper and cardboard FCMs and parameters affecting chemical migration need to be accounted for prior to reaching general consensus on criteria for sample preparation procedures. [ABSTRACT FROM AUTHOR]

Paper sludge is the water treatment waste, which produced during paper production. Paper sludge (PS) waste utilization is the common problem in the EU and internationally. According to the waste management directive No. 2008/98/EC, paper sludge waste should not be utilized in landfills. In the European Union, alone 93 million tons of PS generated yearly. Nowadays most of the paper sludge waste used as fuel for incineration power plants (up to 55 %). According to waste management legislation such waste management should be avoided as well. Very small portion (10 %) of PS is used in construction sector. In construction, paper sludge used as additive in concrete composite materials. Such legislation of waste management generates the motivation of this study. In this study authors propose to produce composite panels in which PS is the main material of composite. As the binding material, clay proposed due to its good binding properties and therefore its natural material. Such produced panels proposed to use it for sound absorption applications. To determine composites sound absorption coefficient standard ISO 10534-2 method was used. The sound absorption coefficient in different octave bands reached up to 0.59. [ABSTRACT FROM AUTHOR]

The article seeks to advance understanding of the involvement of transnational student associations in European governance of higher education policies within the European Union (EU) and the European Higher Education Area (EHEA). Specifically, the article explores the mechanisms for interest intermediation that exist for transnational student associations in both policy arenas. Three transnational student associations stand out in terms of their involvement: European Students' Union (ESU), Erasmus Student Network (ESN) and European Students' Forum (AEGEE). The findings point to two distinct models of student interest intermediation in European policy-making. Within the EU, the European Commission interacts with all three transnational student associations; however, ESU and ESN participate in more expert and working groups. The roles afforded to each association in relation to the European Commission are demarcated and functionally differentiated. Within EHEA, in neo-corporatist fashion, ESU, as a representative platform of national student unions, holds representational monopoly. In the EHEA and the EU, the involvement of transnational student associations in policy-making can be attributed to the evolving nature of transnational governance regimes in which participation of transnational student associations not only brings expertise to but also aids the legitimacy of the policy processes and outcomes.

Marketing-authorization holders evaluate the effectiveness of risk minimization measures (RMM) for medicines through the conduct of post-authorization safety studies (PASS). Earlier studies show that concluding on RMM effectiveness is challenging. The aim of this study was to describe reported limitations associated with RMM effectiveness assessments of industry-sponsored PASS that did not render a conclusion. We conducted a thematic analysis of study limitations extracted from assessment reports and study reports finalized by the Pharmacovigilance Risk Assessment Committee between 2018 and 2021. In 39 (61.0%) of the PASS a conclusion on RMM effectiveness was drawn, where 25 (39.0%) PASS was inconclusive. Most PASS had a cross-sectional design with surveys as primary data sources (73.4% and 65.6% respectively). Four main themes emerged: (i) survey-specific limitations, (ii) limitations specifically related to secondary use of data, (iii) general limitations related to study design, and (iv) limitations not related to study design. In general, frequently reported limitations were survey-related, such as selection bias or information bias. Interestingly, well-known study limitations related to secondary use of data such as missing or misclassification of data were more often presented in inconclusive compared with conclusive PASS. Given that about 40% of PASS did not allow a conclusion on RMM effectiveness, our results suggest prioritization for strategies to mitigate limitations related to the secondary use of data at the protocol stage, for example, through feasibility assessments. Although many databases may have incomplete registration of some variables, feasibility testing prior to conducting a PASS could contribute to meeting study objectives and concluding on RMM effectiveness., (© 2024 The Author(s). Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)