Compiling terminology in EU directives and national transplant regulations. Case study: Sweden and Poland

AbstractThis paper discusses the problem of translating into Polish and Swedish medical terms and definitions contained in the EU directives on human cells, tissues and organs for transplant. The author briefly discusses the issue of translating medical terms and of creating concept definitions. The translated terms and definitions are then compared with their equivalents in national regulations. Transplantology is a relatively new and dynamically developing field of medicine, hence its terminology poses a challenge to translators. The results of work done by EU translators and terminologists are verified in the course of implementing the directives into the national law. The author focuses on the Swedish methods of team work within the National Tissue Project and highlights the positive effects of this work.

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Opportunities and Threats for Polish Power Industry and for Polish Coal: A Case Study in Poland

Energies ◽

10.3390/en14206638 ◽

2021 ◽

Vol 14 (20) ◽

pp. 6638

Author(s):

Dariusz Fuksa

Keyword(s):

Energy Security ◽

Renewable Energy Sources ◽

Mining Industry ◽

Power Industry ◽

Energy Sources ◽

Negative Effects ◽

Eu Directives ◽

Climate And Energy Policy ◽

The Eu

This article analyses opportunities and threats for the Polish power industry resulting from the EU climate and energy policy. The main assumptions of the policy and directives resulting from it with regard to climate protection and the use of renewable energy sources (RES) in the production of electricity and heat are presented. The negative effects (threats) for Poland in meeting the EU requirements are discussed. The paper also discusses the opportunities for Polish coal, proposing solutions to meet EU directives and to maintain energy security without having to give up Polish coal. Reference is made as well to the plans to liquidate the Polish mining industry, indicating solutions opposing such actions.

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Modernisation of Higher Education – Willful Action or Wishful Thinking? The Case of Bulgaria

Педагогически форум ◽

10.15547/pf.2020.018 ◽

2020 ◽

Vol 8 (3) ◽

pp. 3-17

Author(s):

Elena Blagoeva

Keyword(s):

Higher Education ◽

Economic Crisis ◽

Negative Impact ◽

National Level ◽

Sustainable Growth ◽

Research Approach ◽

Case Study Methodology ◽

The Impact ◽

The Eu

The impact of the last global economic crisis (2008) on the European economy put a strain on higher education (HE), yet it also pushed the sector towards intensive reforms and improvements. This paper focuses on the “Strategy for the Development of Higher Education in the Republic of Bulgaria 2014-2020”. With a case study methodology, we explore the strategic endeavours of the Bulgarian government to comply with the European directions and to secure sustainable growth for the HE sector. Our research question is ‘How capable is the Bulgarian HE Strategy to overcome the economic and systemic restraints of Bulgarian higher education?’. Because the development of strategies for HE within the EU is highly contextual, a single qualitative case study was chosen as the research approach. HE institutions are not ivory towers, but subjects to a variety of external and internal forces. Within the EU, this is obviated by the fact that Universities obtain their funds from institutions such as governments, students and their families, donors, as well as EU-level programmes. Therefore, to explore how these pressures interact to affect strategic action on national level, the case method is well suited as it enabled us to study the phenomena thoroughly and deeply. The paper suggests the actions proposed within the Strategy have the potential to overcome the delay, the regional isolation and the negative impact of the economic crisis on the country. Nevertheless, the key elements on which the success or failure of this Strategy hinges are the control mechanisms and the approach to implementation. Shortcomings in these two aspects of strategic actions in HE seem to mark the difference between gaining long-term benefits and merely saving face in front of international institutions.

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Water Protection Via the Implementation of EU Directives - Case Study of Hungary

SSRN Electronic Journal ◽

10.2139/ssrn.2442021 ◽

2014 ◽

Author(s):

GGbor Kecskks

Keyword(s):

Water Protection ◽

Eu Directives

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APPLICATION OF DOMAIN INTEGRATED DESIGN METHODOLOGY FOR BIO-INSPIRED DESIGN- A CASE STUDY OF SUTURE PIN DESIGN

Proceedings of the Design Society ◽

10.1017/pds.2021.49 ◽

2021 ◽

Vol 1 ◽

pp. 487-496

Author(s):

Pavan Tejaswi Velivela ◽

Nikita Letov ◽

Yuan Liu ◽

Yaoyao Fiona Zhao

Keyword(s):

Cross Sections ◽

Design Methodology ◽

Reaction Force ◽

Integrated Design ◽

Total Deformation ◽

Insertion Force ◽

Force Reaction ◽

The Moment ◽

Work Done

AbstractThis paper investigates the design and development of bio-inspired suture pins that would reduce the insertion force and thereby reducing the pain in the patients. Inspired by kingfisher's beak and porcupine quills, the conceptual design of the suture pin is developed by using a unique ideation methodology that is proposed in this research. The methodology is named as Domain Integrated Design, which involves in classifying bio-inspired structures into various domains. There is little work done on such bio-inspired multifunctional aspect. In this research we have categorized the vast biological functionalities into domains namely, cellular structures, shapes, cross-sections, and surfaces. Multi-functional bio-inspired structures are designed by combining different domains. In this research, the hypothesis is verified by simulating the total deformation of tissue and the needle at the moment of puncture. The results show that the bio-inspired suture pin has a low deformation on the tissue at higher velocities at the puncture point and low deformation in its own structure when an axial force (reaction force) is applied to its tip. This makes the design stiff and thus require less force of insertion.

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The Wetland Contract as a Tool for Successful Wetland Governance: A Case Study of Ljubljansko Barje Nature Park, Slovenia

Sustainability ◽

10.3390/su13010425 ◽

2021 ◽

Vol 13 (1) ◽

pp. 425

Author(s):

Katarina Polajnar Horvat ◽

Ales Smrekar

Keyword(s):

Wetland Management ◽

Stakeholder Participation ◽

Shared Responsibility ◽

Economic Activities ◽

Wetland Ecosystems ◽

Positive Effects ◽

Management And Development ◽

Nature Park ◽

Ljubljansko Barje

Our research focuses on implementing multilevel governance of wetlands to achieve an effective participatory process and its overall positive effects on wetland ecosystems and their protection as well as on local sustainable development. The aim of the research is to develop a methodology for establishing the Wetland Contract, a voluntary agreement to foster sustainable management and development of wetlands, to ensure greater coordination and consensus building between various stakeholders involved in management and to limit conflicts between preservation issues and economic activities in wetlands. The Wetland Contract and the integration process for establishing it in Ljubljansko barje Nature Park proved itself able to overcome conflicts between institutional and legal jurisdiction and is showing itself to be a dynamic path capable of activating a desirable relationship between various interests and supporting new forms of multi-sectoral stakeholder participation in wetland management. It has also contributed to a dialogue and shared responsibility among stakeholders.

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The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA

Pharmaceutics ◽

10.3390/pharmaceutics13010048 ◽

2020 ◽

Vol 13 (1) ◽

pp. 48

Author(s):

Ioana Gherghescu ◽

M. Begoña Delgado-Charro

Keyword(s):

Drug Administration ◽

Action Plan ◽

European Medicines Agency ◽

Patient Access ◽

Clinical Evaluations ◽

The Past ◽

The Us ◽

Improve Patient ◽

The Eu

Biosimilar medicines expand the biotherapeutic market and improve patient access. This work looked into the landscape of the European and US biosimilar products, their regulatory authorization, market availability, and clinical evaluation undergone prior to the regulatory approval. European Medicines Agency (EMEA, currently EMA) and Food and Drug Administration (FDA) repositories were searched to identify all biosimilar medicines approved before December 2019. Adalimumab biosimilars, and particularly their clinical evaluations, were used as a case study. In the past 13 years, the EMA has received 65 marketing authorization applications for biosimilar medicines with 55 approved biosimilars available in the EU market. Since the first biosimilar approval in 2015, the FDA has granted 26 approvals for biosimilars with only 11 being currently on the US market. Five adalimumab biosimilars have been approved in the EU and commercialized as eight different medicines through duplicate marketing authorizations. Whilst three of these are FDA-approved, the first adalimumab biosimilar will not be marketed in the US until 2023 due to Humira’s exclusivity period. The EU biosimilar market has developed faster than its US counterpart, as the latter is probably challenged by a series of patents and exclusivity periods protecting the bio-originator medicines, an issue addressed by the US’s latest ‘Biosimilar Action Plan’.

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Digital forensics and evolving cyber law: case of BIMSTEC countries

Journal of Money Laundering Control ◽

10.1108/jmlc-02-2019-0019 ◽

2019 ◽

Vol 22 (4) ◽

pp. 744-752

Author(s):

Sisira Dharmasri Jayasekara ◽

Iroshini Abeysekara

Keyword(s):

Information Technology ◽

Design Methodology ◽

Digital Forensics ◽

Content Type ◽

Global Context ◽

Study Approach ◽

Legal Frameworks ◽

Work Done

Purpose The purpose of this paper is to discuss the role of digital forensics in an evolving environment of cyber laws giving attention to Bay of Bengal Initiative for Multi-Sectoral Technical and Economic Cooperation (BIMSTEC) countries, comprising Bangladesh, India, Myanmar, Sri Lanka, Thailand, Nepal and Bhutan, in a dynamic global context. Design/methodology/approach This study uses a case study approach to discuss the digital forensics and cyber laws of BIMSTEC countries. The objective of the study was expected to be achieved by referring to decided cases in different jurisdictions. Cyber laws of BIMSTEC countries were studied for the purpose of this study. Findings The analysis revealed that BIMSTEC countries are required to amend legislation to support the growth of information technology. Most of the legislation are 10-15 years old and have not been amended to resolve issues on cyber jurisdictions. Research limitations/implications This study was limited to the members of the BIMSTEC. Originality/value This paper is an original work done by the authors who have discussed the issues of conducting investigations with respect to digital crimes in a rapidly changing environment of information technology and deficient legal frameworks.

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Incorporating Ecosystem Services in the Assessment of Water Framework Directive Programmes of Measures

Environmental Management ◽

10.1007/s00267-021-01478-7 ◽

2021 ◽

Author(s):

Ioannis Souliotis ◽

Nikolaos Voulvoulis

Keyword(s):

Ecosystem Services ◽

Water Framework Directive ◽

Water Status ◽

Monitoring And Evaluation ◽

Well Being ◽

Ecological Condition ◽

Costs And Benefits ◽

Ecological Objectives ◽

The Eu

AbstractThe EU Water Framework Directive requires the development of management responses aimed towards improving water quality as a result of improving ecosystem health (system state). Ecosystems have potential to supply a range of services that are of fundamental importance to human well-being, health, livelihoods and survival, and their capacity to supply these services depends on the ecosystem condition (its structure and processes). According to the WFD, Programmes of Measures should be developed to improve overall water status by reducing anthropogenic catchment pressures to levels compatible with the achievement of the ecological objectives of the directive, and when designed and implemented properly should improve the ecological condition of aquatic ecosystems that the delivery of ecosystem services depends on. Monitoring and evaluation of implemented measures are crucial for assessing their effectiveness and creating the agenda for consecutive planning cycles. Considering the challenges of achieving water status improvements, and the difficulties of communicating these to the wider public, we develop a framework for the evaluation of measures cost-effectiveness that considers ecosystem services as the benefits from the reduction of pressures on water bodies. We demonstrate its application through a case study and discuss its potential to facilitate the economic analysis required by the directive, and that most European water authorities had problems with. Findings demonstrate the potential of the methodology to effectively incorporate ecosystem services in the assessment of costs and benefits of proposed actions, as well as its potential to engage stakeholders.

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