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Emerging Radionuclides in a Regulatory Framework for Medicinal Products – How Do They Fit?Decristoforo, Clemens, Neels, Oliver, Patt, Marianne 24 March 2023 (has links)
Recent years have seen the establishment of several radionuclides as medicinal
products in particular in the setting of theranostics and PET. [177Lu]Lutetium Chloride or
[64Cu]Copper Chloride have received marketing authorization as radionuclide precursor,
[68Ga]Gallium Chloride has received regulatory approval in the form of different
68Ge/68Ga generators. This is a formal requirement by the EU directive 2001/83,
even though for some of these radionuclide precursors no licensed kit is available
that can be combined to obtain a final radiopharmaceuticals, as it is the case for
Technetium-99m. In view of several highly promising, especially metallic radionuclides
for theranostic applications in a wider sense, the strict regulatory environment poses the
risk of slowing down development, in particular for radionuclide producers that want
to provide innovative radionuclides for clinical research purposes, which is the basis
for their further establishment. In this paper we address the regulatory framework for
novel radionuclides within the EU, the current challenges in particular related to clinical
translation and potential options to support translational development within Europe
and worldwide.
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From election to insurrection : A Speech Act Theory study of Donald Trump’s tweets in the wake of the 2020 election.Karapostoli, Paraskevi January 2022 (has links)
This essay utilizes Speech Act Theory to assess Donald Trump’s role in inciting the riot that took place in Washington D.C. on the 6th of January, 2021 and culminated with the attack on the Capitol building. For the purposes of the study a corpus was created with tweets collected from the Trump Twitter Archive. The tweets cover the span between the latest presidential election, on the 3rd of November, 2020, to the day of the attack. The corpus was read manually and sorted into themes. The themes that emerged show that: a) Trump was convinced of his victory, b) felt that the election was rigged, c) accused news networks, the Democrats and even prominent Republicans for his loss, and d) called the people for action. A quantitative method that identified the most common words in the corpus corroborated the identification of the described themes. The themes were compared to Speech Act Theory’s felicitous conditions for directive speech acts. The study found that Trump’s tweets satisfy the conditions for the successful directive speech acts of Order and Command, thus providing grounds to make the case that he was responsible for inciting the attack.
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Ska företagens hållbarhetsarbete regleras överstatligt? : En kvalitativ textanalys av ett antal svenska aktörers inställning till EU-direktivet 2022/2464 angående "Corporate Sustainability Reporting Directive"Rosendahl, Ebba January 2024 (has links)
This thesis aims to investigate the attitudes of several Swedish stakeholders towards regulating the business sector from a sustainability perspective. Focusing on the European Union's Corporate Sustainability Reporting Directive (CSRD), the study furthermore aims to examine the stakeholder’s positions on supranational versus national regulation of the business sector. By examining the early stage of Swedish implementation of the EU's CSRD directive, the study aims to contribute new empirical evidence to research in Corporate Social Responsibility and national implementation of supranational regulations. The study also aims to provide additional empirical support for current theories on stakeholders' attitudes toward national implementation of supranational regulations with CSR in mind. What are the perceptions of Swedish political parties, businesses, and environmental organizations regarding the growing standardization and supranational regulation of business introduced by the EU's new directive CSRD? Utilizing a qualitative method, viewpoints from the stakeholders were examined and compared to each other. Findings reveal that left-leaning parties are generally more favorable towards the EU directive compared to right-leaning counterparts. While the business sector demonstrates some acceptance of increased regulation, companies continue to prioritize profit maximization despite potential shifts toward climate-conscious practices. Environmental organizations exhibit nuanced viewpoints, expressing reservations about the directive's efficacy in achieving climate goals. The conclusions suggest a shift in the landscape of resistance to EU influence in Sweden, with right-wing populist parties and environmental organizations emerging as key players rather against supranational business regulation. Thus, the business sector might be viewed as more climate-conscious than expected.
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Communication is key : Corporate sustainability reporting directives indirect effect on small companies' communicationJacobsen-Lööv, Jacob January 2024 (has links)
Climate change is upon us and the European continent is striving towards reaching the goals set up throughout the EU-green deal, the overarching transitioning plan for Europe to reduce its emissions by 55% by 2030 and net zero emissions by 2050. One of the newest frameworks to facilitate this change is the corporate sustainability reporting directive. The directive affects big companies and is written in such a way that the coverage of the scope is gradual, so today only listed firms are covered. This research investigates how companies not yet covered by the directive adapt their communication and efforts to align with the directive. It does this by studying the aim: This report aims to explain motives for small and unlisted companies while communicating their corporate social responsibility reporting. The overall objective of the project is to understand their communication and connection to the CSRD- and hence how they prepare for new environmental legislation. It will do this by looking into four IT and consultancy firms based in Stockholm where marketing material as well as sustainability reports has been viewed. The research was done with a flexible design and builds on a literature review covering CSR historic communication, legitimacy theory, Stakeholder theory, and the Triple bottom line, altogether constructing the conceptual framework. The results show that companies communicate by sense giving characteristics in a one-way fashion. Business should involve their stakeholders more in their communication, enabling them to be fast movers concerning the CSRD as well as by competitive reasons. It also shows the value of including external stakeholders. The results also show that companies' communication is focused on the social aspects of sustainability, it is misplaced in focus, and to communicate in line with the CSRD they should communicate emissions as well as anti-corruption, equality, and employee rights. Even though unnoted companies are not covered, there are clear advantages of reporting in line with the directive.
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ANALYSIS OF MONITORING NETWORK SPATIAL AND TEMPORAL REDUCTION AND THEIR CONSEQUENCES ON THE ECOLOGICAL CLASSIFICATION IN THE SCOPE OF WATER FRAME DIRECTIVEAbramic, Andrej 15 May 2013 (has links)
La Directiva Marco Europea del Agua es la norma legislativa más importante que ha establecido la Comisión Europea, en materia de aguas, y constituye un importante avance para lograr una gestión sostenible del agua. Esta norma exige que todas las aguas, alcancen en el 2015 un status bueno e indica los pasos a seguir para conseguirlo, mediante el establecimiento de objetivos ecológicos y medioambientales en las mismas. Para concretar estos objetivos, la DMA ha establecido un sistema de indicadores biológicos, hidro-morfológicos y fisicoquímicos que determinan la calidad ecológica de las diferentes masas de agua.
Para proporcionar una clasificación ecológica de las masas de agua costeras en la Comunidad Valencia existe una red de monitoreo costera que analiza la biomasa de fitoplancton, de forma indirecta a partir de la clorofila a. En las mismas, se establece la calidad de las aguas costeras en base al valor del percentil 90 del total de mediciones de clorofila a recogidas en sucesivas campañas mensuales durante un período de 5 años.
Se ha considerado la posibilidad de reducir el número de campañas realizadas a lo largo del año y la posibilidad de reducir el número de estaciones revisadas en cada campaña y que consecuencias lleva esta reducción por estado ecológico.
Los resultados del estudio exploratorio para la reducción temporal, muestran que una reducción no controlada en el número de campañas realizadas a lo largo del año en las aguas costeras valencianas, puede producir alteraciones impredecibles en su clasificación ecológica. Un estudio conjunto de las series pluviométricas, de oleaje, salinidad y clorofila a, para los tres climas marítimos presentes en las aguas costeras valencianas, ha permitido observar que el equilibrio trófico de los ecosistemas, en esta zona, depende tanto de la influencia antropogénica como de factores medioambientales determinados por la estacionalidad e irregularidad del clima. En base a ello, se han definido tres tipos de ecosistema / Abramic, A. (2011). ANALYSIS OF MONITORING NETWORK SPATIAL AND TEMPORAL REDUCTION AND THEIR CONSEQUENCES ON THE ECOLOGICAL CLASSIFICATION IN THE SCOPE OF WATER FRAME DIRECTIVE [Tesis doctoral]. Universitat Politècnica de València. https://doi.org/10.4995/Thesis/10251/28851
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Policy mobility med EU:s nya dricksvattendirektiv : Hur rör sig policy fram till implementering?Jagdmann, Hannes January 2024 (has links)
Vad för förutsättningar ges det för aktörer i Sverige som ska implementera policies rörande dricksvatten? Är det styrning från sådd till skörd för att nå de uppsatta direktiven eller är det upp till aktörerna att hitta de lösningar som är bäst lämpade till de geografiska förutsättningarna som skiljer sig åt över Sverige? I intervjuer med en dricksvattenexpert och en projektledare inom dricksvattenarbete ges insikter om hur ett policydirektiv på EU-nivå kan anpassas efter lokal, regional och nationell nivå, genom samverkan från individers olika erfarenheter och tolkningar av direktivet, så kallad policy mobility. För att se om nuvarande dricksvattendirektiv kan förstås utifrån begreppet policy mobility genomfördes en dokumentanalys av direktivet och offentliga dokument som gäller implementering av den i Sverige. Det går att utläsa att de offentliga dokumenten öppnar upp för en implementeringsmetod som policy mobility då direktivet är förhållandevis generellt, och förutsätter viss anpassning på nationell såväl som lokal och regional nivå. EU använder sig av territoriell styrning vilket skapar förutsättning för anpassningar för direktiv då det lyfter att geografiska förutsättningar skiljer sig åt mellan medlemsstater vilket innebär att ett sätt inte fungerar likadant överallt. Den lyfter även att det skiljer medlemsstaterna åt om vilken nivå, och hur, beslut kan tas på, som ett förtydligande av subsidiaritetsprincipen. För att kunna implementera dricksvattendirektivet krävs en anpassning till specifika geografiska förutsättningar. Dricksvattendirektivet är ett minimidirektiv, ett antal mål ställs upp men ingen vägledning till hur de ska uppnås medan medlemsstater får rätt till att själva sätta högre mål. Denna uppsats visar att policy mobility har varit närvarande vid arbetet av implementering av dricksvattendirektivet.
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Improving energy performance within the framework of the Energy Efficiency DirectiveÅkerblom, Signe January 2015 (has links)
It is necessary for large companies to understand and be able to adapt to the industrial transformation towards an increasing focus on energy efficiency, which takes place today. The Energy Efficiency Directive (EED)issued by the European Union has enlarged the focus on working with energy efficiency within large companies. Further, the Swedish government has introduced the law about energy auditing in large companies, which is based on the EED. These regulations encourage companies to develop a management system that includes requirements on conducting energy audits and propose cost effective measures. Energy efficiency is already an important aspect within many companies environmental work, however a more developed and systematic approach to energy efficiency than most companies already have is needed in order to fulfill the legal requirements. The Company investigated in this study is one the world’s leading technology companies with more than 9000 employees in Sweden. Currently, they have energy as a significant aspect in their environmental work according to the international management system standard ISO 14001. Today they are also developing their energy work by conducting energy audits in order to comply with the new legislation. This gives a more detailed view of the energy use and potential improvements that can be done, but in order to ensure continual improvements over a long period of time further measures are needed. Within this study it was investigated what measures a large company needs to implement in order to increase their energy performance and comply with the legislation. By a literature review focusing on management systems as well as interviews within the Company, a complementary study with two companies covered by the EED and three expert interviews, five key factors were identified. These factors are top management commitment, awareness, goals, measurements and evaluation. A model was then developed aligning these factors. Further, concrete proposals for action to manage these factors were presented. By increasing focus on these key factors and implement proposed measures companies will increase their energy performance and make the organization aware of how actions affect a company’s energy performance.
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Insights into Companies’ Adoption of the Corporate Sustainability Reporting DirectiveLitinska, Ieva Helēna, Oprea, Raluca-Cosmina January 2024 (has links)
The European Union entered into force the Corporate Sustainability Reporting Directive (CSRD), which represents a comprehensive framework to enhance transparency and accountability in corporate sustainability reporting. The study focuses on the organisational change processes and attitudes activated in the companies by the implementation of mandatory sustainability reporting under the CSRD. The study aims to provide insights into the practical adoption of the CSRD from an organisational change perspective. While prior studies have concentrated on more isolated aspects of CSRD implementation, this paper offers a holistic outlook on the entirety of the change processes involved. To achieve the goal, nine semi-structured interviews were conducted with sustainability professionals representing various organisations that are obligated to report under the CSRD in 2025 and 2026. This study develops an analytical framework combining Corporate Social Responsibility theory and Organisational Change frameworks. The results indicate that the CSRD serves as a catalyst for organisational change in all companies, regardless of their prior reporting practices. In managing this change, companies have to integrate sustainability and market concerns into their strategies.
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Indicateurs biologiques de la qualité écologique des cours d’eau : variabilités et incertitudes associées / Ecological assessment of running waters using bio-indicators : associated variability and uncertaintyMarzin, Anahita 11 January 2013 (has links)
Evaluer, maintenir et restaurer les conditions écologiques des rivières nécessitent des mesures du fonctionnement de leurs écosystèmes. De par leur complexité, notre compréhension de ces systèmes est imparfaite. La prise en compte des incertitudes et variabilités liées à leur évaluation est donc indispensable à la prise de décision des gestionnaires. En analysant des données nationales (~ 1654 sites), les objectifs principaux de cette thèse étaient de (1) tester certaines hypothèses intrinsèques aux bio-indicateurs et (2) d'étudier les incertitudes de l'évaluation écologique associées à la variabilité temporelle des bio-indicateurs et à la prédiction des conditions de référence. (1) Ce travail met en évidence (i) le rôle prépondérant des facteurs environnementaux naturels dans la structuration des communautés aquatiques en comparaison des facteurs anthropiques (définis à l'échelle du bassin versant, du corridor riparien et du tronçon), (ii) les réponses contrastées des communautés aquatiques aux pressions humaines (dégradations hydro-morphologiques et de la qualité de l'eau) et (iii) plus généralement, les forts impacts des barrages et de l'altération de la qualité de l'eau sur les communautés aquatiques. (2) Une méthode Bayésienne a été développée pour estimer les incertitudes liées à la prédiction des conditions de référence d'un indice piscicole (IPR+). Les incertitudes prédictives de l'IPR+ dépendent du site considéré mais aucune tendance claire n'a été observée. Par comparaison, la variabilité temporelle de l'IPR+ est plus faible et semble augmenter avec l'intensité des perturbations anthropiques. Les résultats de ce travail confirment l'avantage d'indices multi-métriques basés sur des traits fonctionnels par rapport à ceux relatifs à la composition taxonomique. Les sensibilités différentes des macrophytes, poissons, diatomées et macro-invertébrés aux pressions humaines soulignent leur complémentarité pour l'évaluation des écosystèmes fluviaux. Néanmoins, de futures recherches sont nécessaires à une meilleure compréhension des effets d'interactions entre types de pressions et entre pressions humaines et environnement. / Sensitive biological measures of ecosystem quality are needed to assess, maintain or restore the ecological conditions of rivers. Since our understanding of these complex systems is imperfect, river management requires recognizing variability and uncertainty of bio-assessment for decision-making. Based on the analysis of national data sets (~ 1654 sites), the main goals of this work were (1) to test some of the assumptions that shape bio-indicators and (2) address the temporal variability and the uncertainty associated to prediction of reference conditions.(1) This thesis highlights (i) the predominant role of physiographic factors in shaping biological communities in comparison to human pressures (defined at catchment, riparian corridor and reach scales), (ii) the differences in the responses of biological indicators to the different types of human pressures (water quality, hydrological, morphological degradations) and (iii) more generally, the greatest biological impacts of water quality alterations and impoundments. (2) A Bayesian method was developed to estimate the uncertainty associated with reference condition predictions of a fish-based bio-indicator (IPR+). IPR+ predictive uncertainty was site-dependent but showed no clear trend related to the environmental gradient. By comparison, IPR+ temporal variability was lower and sensitive to an increase of human pressure intensity. This work confirmed the advantages of multi-metric indexes based on functional metrics in comparison to compositional metrics. The different sensitivities of macrophytes, fish, diatoms and macroinvertebrates to human pressures emphasize their complementarity in assessing river ecosystems. Nevertheless, future research is needed to better understand the effects of interactions between pressures and between pressures and the environment.
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Perspektivy veřejného zadávání v kontextu revize práva Evropské unie / Perspectives of public contracts in the context of revision of the European Union’s lawVránová, Iveta January 2013 (has links)
Diploma thesis with the topic "Perspectives of public contracts in the context of revision of the European Union's law", provides a summary of the most important changes brought by the transposition of the European Directive to the Czech Law. This thesis is based on the Public Contracts Directive 2014/24/EU, dated 26th February 2014, which replaced the previous Public Contracts Directive 2004/18/ES, and Directive 2014/25/EU, which replaced the Directive 2004/17/ES. The thesis deals with the reasons leading to the change of all mentioned Directives as well as with the "technical amendment" of the Public Procurement Act No. 137/2006 Coll., which has been in effect since the 1st of January 2014.
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