scholarly journals Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey

2021 ◽  
Author(s):  
Samantha Cruz Rivera ◽  
Barbara Torlinska ◽  
Eliot Marston ◽  
Alastair K. Denniston ◽  
Kathy Oliver ◽  
...  
Keyword(s):  
Pay For Performance ◽  
Regulatory Science ◽  
International Strategy ◽  
Free Text ◽  
The European Union ◽  
Accurate Definition ◽  
Definition Of ◽  
Healthcare Innovation ◽  
The Uk ◽  
Medium Enterprises

Abstract Background The UK’s transition from the European Union creates both an urgent need and key opportunity for the UK and its global collaborators to consider new approaches to the regulation of emerging technologies, underpinned by regulatory science. This survey aimed to identify the most accurate definition of regulatory science, to define strategic areas of the regulation of healthcare innovation which can be informed through regulatory science and to explore the training and infrastructure needed to advance UK and international regulatory science. Methods A survey was distributed to UK healthcare professionals, academics, patients, health technology assessment agencies, ethicists and trade associations, as well as international regulators, pharmaceutical companies and small or medium enterprises which have expertise in regulatory science and in developing or applying regulation in healthcare. Subsequently, a descriptive quantitative analyses of survey results and directed thematic analysis of free-text comments were applied. Results Priority areas for UK regulatory science identified by 145 participants included the following: flexibility: the capability of regulations to adapt to novel products and target patient outcomes; co-development: collaboration across sectors, e.g. patients, manufacturers, regulators, and educators working together to develop appropriate training for novel product deployment; responsiveness: the preparation of frameworks which enable timely innovation required by emerging events; speed: the rate at which new products can reach the market; reimbursement: developing effective tools to track and evaluate outcomes for “pay for performance” products; and education and professional development. Conclusions The UK has a time-critical opportunity to establish its national and international strategy for regulatory science leadership by harnessing broader academic input, developing strategic cross-sector collaborations, incorporating patients’ experiences and perspectives, and investing in a skilled workforce.

8. Referendums

UK Politics ◽  
2021 ◽  
pp. 171-191
Author(s):  
Andrew Blick
Keyword(s):  
Direct Democracy ◽  
Local Level ◽  
The European Union ◽  
The Public ◽  
Key Features ◽  
Definition Of ◽  
The Uk ◽  
The Relationship ◽  
Theoretical Considerations ◽  
Political Decisions

This chapter starts with a definition of the term ‘referendum’. A referendum is a means of involving the public in political decisions via voting on specific issues such as leaving the European Union. The chapter focuses on the use of referendums at the local level. It sets out the key features of a referendum. Who is allowed to vote in referendums? What sort of questions are put to voters? Under want circumstances should a referendum take place on specific issues? What are the risks associated with holding a referendum? The chapter also looks at regulations surrounding referendums in the UK. The theoretical considerations that the chapter examines are the fact that a referendum subject tends to be controversial, the relationship between referendums and direct democracy and the implications of the results.

scholarly journals Innovations and Other Processes as Identifies of Contemporary Trends in the Sustainable Development of SMEs: The Case of Emerging Regional Economies

2018 ◽  
Author(s):  
Krzysztof Malik ◽  
Anna Jasińska-Biliczak
Keyword(s):  
Sustainable Development ◽  
Emerging Economies ◽  
Small And Medium Enterprises ◽  
Regional Level ◽  
Regional Economies ◽  
The European Union ◽  
The Sustainable Development ◽  
Definition Of ◽  
Medium Enterprises ◽  
Implementation Of Innovations

Small and medium enterprises (SMEs) are the biggest group of enterprises in the European Union (EU); they are also characteristic for emerging economies. Given this situation, there is a need to provide instruments such as processes, which allows them to realize a model of sustainable development. The ability to classify processes and occurrences happening inside these processes often affects the condition of the enterprises. The implementation of innovations, as identified process, enables the directions of SME development towards sustainable development. The purpose of this article is to find out if the identification of processes such as innovations, have any influence on the competitiveness and sustainable development of SMEs. This study was based on pilot research, which examined small and medium enterprises at the regional level, at the example of Polish emerging economy region. It was researched under the angle of the identification of processes and changes happening inside enterprises in terms of understanding the sustainable development concept. Research composition allows to present an understanding by the SMEs of the problems analyzed. The novelty was in the new questionnaire, the definition of sustainable development, and matching those processes identified by the enterprises analyzed with the particular sustainable development dimensions suggested by the authors. In light of the analysis of the literature and the results of this research the important contributions of this study are as follows. This approach pointed the understanding and practical meaning of the identification of processes to be understood. The most important finding was that there is a need to make entrepreneurs aware of the fact that innovations are also processes in themselves, which often constitutes the sum of other supporting processes occurring in the enterprise. Support in the form of knowledge transfer from experts to SMEs would also be recommended.

scholarly journals What do doctors understand by spiritual health? A survey of UK general practitioners

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e045110
Author(s):  
Orla Whitehead ◽  
Carol Jagger ◽  
Barbara Hanratty
Keyword(s):  
General Practitioners ◽  
Online Survey ◽  
Research Question ◽  
A Priori ◽  
Full Range ◽  
Spiritual Health ◽  
Free Text ◽  
Consensus Definition ◽  
Definition Of ◽  
The Uk

BackgroundIn the UK, doctors’ regulatory and professional bodies require general practitioners (GPs) to consider discussing spiritual health as part of the consultation. However, spiritual health is not defined in guidance, and it is unknown what individual doctors understand by the term.Research questionWhat do GPs understand by the term ‘spiritual health’?AimTo explore how GPs understand and define spiritual health.Design and settingSurvey of GPs in England 9 April 2019–21 May 2019.MethodA mixed-methods online survey asked practising GPs in England qualitative free text questions—‘What does the term ‘Spiritual Health’ mean to you?’ and ‘Any comments?’ after five vignettes about discussing spiritual health with patients. These were subject to thematic analysis using a priori themes from the literature on GP definitions of spiritual health, and on attitudes towards the topic.Participants177 practising GPs in England.Results177 GPs responded to the survey. Understanding of spiritual health fitted into three themes: self-actualisation and meaning, transcendence and relationships beyond the self, and expressions of spirituality. A full range of views were expressed, from a minority who challenged their role in spiritual health, through to others enthusiastic about its place in healthcare.ConclusionSpirituality and religiosity are understood by English GPs to be distinct concepts. A consensus definition of spiritual health incorporating the themes identified by working doctors, may be helpful to support GPs to follow the recommended guidance in their practice.

scholarly journals AUTOMATIC STRUCTURING OF SEMANTIC WEB SERVICES – AN APPROACH

2015 ◽  
pp. 242-245
Author(s):  
B. KAMALA ◽  
J. M. NANDHINI
Keyword(s):  
Web Services ◽  
Semantic Web ◽  
Free Text ◽  
Description Language ◽  
Inverse Document Frequency ◽  
Document Frequency ◽  
Accurate Definition ◽  
Definition Of ◽  
Machine Readable ◽  
The Web

Ontologies have become the effective modeling for various applications and significantly in the semantic web. The difficulty of extracting information from the web, which was created mainly for visualising information, has driven the birth of the semantic web, which will contain much more resources than the web and will attach machine-readable semantic information to these resources. Ontological bootstrapping on a set of predefined sources, such as web services, must address the problem of multiple, largely unrelated concepts. The web services consist of basically two components, Web Services Description Language (WSDL) descriptors and free text descriptors. The WSDL descriptor is evaluated using two methods, namely Term Frequency/Inverse Document Frequency (TF/IDF) and web context generation. The proposed bootstrapping ontological process integrates TF/IDF and web context generation and applies validation using the free text descriptor service, so that, it offers more accurate definition of ontologies. This paper uses ranking adaption model which predicts the rank for a collection of web service documents which leads to the automatic construction, enrichment and adaptation of ontologies.

26. Subject matter: The requirement that there be a design

2018 ◽  
Author(s):  
L. Bently ◽  
B. Sherman ◽  
D. Gangjee ◽  
P. Johnson
Keyword(s):  
Public Policy ◽  
European Union ◽  
Subject Matter ◽  
Community Design ◽  
The European Union ◽  
Broad Definition ◽  
Technical Function ◽  
Definition Of ◽  
The Uk

This chapter considers the requirements for a design to be protected, with particular reference to the requirement that there be a design. It begins by outlining the requirements for validity that are set out in Article 25(1) of the Community Design Regulation before turning to the definition of ‘design’ with respect to registered designs in the UK and the European Union as well as unregistered Community designs, citing three key elements of this definition: appearance, features, and product. It also examines three types of design that are excluded from the very broad definition of design: designs dictated solely by technical function; designs for products that must be produced in a specific way to enable them to connect to another product; and designs that are contrary to morality or public policy.

Sandoz & Hexal v Searle & Janssen Sciences Ireland: What is the formula for patent term extensions?

2017 ◽  
Vol 13 (4) ◽  
pp. 219-221
Author(s):  
Chris Hayes
Keyword(s):  
European Union ◽  
Pharmaceutical Product ◽  
The European Union ◽  
High Court ◽  
Court Of Justice ◽  
Patent Term ◽  
Basic Patent ◽  
Commercially Important ◽  
Definition Of ◽  
The Uk

In Sandoz Ltd & Hexal AG v G.D. Searle LLC & Janssen Sciences Ireland UC [2017] EWHC 987 (Pat), the UK High Court held that an active ingredient in a pharmaceutical product that was claimed only by reference to a Markush formula and not expressly referred to in the patent was “protected” by a basic patent for the purposes of obtaining a patent term extension under the European Union Supplementary Protection Certificate Regulations. This decision will be welcomed by practitioners in adding some clarity to the interpretation of previous decisions of the Court of Justice of the European Union relating to the definition of what is protected by a basic patent in this extremely commercially important and fast-moving area of jurisprudence. The implication of this decision is discussed further in this report.

8. The sovereignty of Parliament

2019 ◽  
pp. 111-126
Author(s):  
Colin Faragher
Keyword(s):  
European Union ◽  
Human Rights ◽  
Eu Law ◽  
The European Union ◽  
Essential Information ◽  
Parliamentary Sovereignty ◽  
Human Rights Act ◽  
Human Rights Act 1998 ◽  
Definition Of ◽  
The Uk

Each Concentrate revision guide is packed with essential information, key cases, revision tips, exam Q&As, and more. Concentrates show you what to expect in a law exam, what examiners are looking for, and how to achieve extra marks. This chapter discusses the definition of parliamentary sovereignty, AV Dicey’s views concerning parliamentary sovereignty, the jurisdiction of the courts, whether the substance of an Act of Parliament can be challenged, the enrolled bill rule; whether the jurisdiction of the court over an Act of Parliament can be enlarged; the rule in Pepper v Hart; entrenchment clauses; prospective formula; the effect of the Human Rights Act 1998; the purposive approach to statutory interpretation; the implications of EU law for parliamentary sovereignty and the end of the supremacy of EU law when the UK exits the European Union.

3.1 The definition of a treaty and its legal effects 5.3.1.1 Definition A treaty is a political agreement between two or more States. Treaties, conventions, charters, codes and agreements are in fact all treaties as defined by the Vienna Convention (despite the differing terms used). The sole difference between a convention and an agreement is that an agreement is usually signed by Heads of Government with no intention that it should be subsequently ratified by the State (for the meaning of ratification and the significance of signing, see below). A bilateral treaty is between two States, a multi-lateral treaty is concluded between more than two States. 5.3.1.2 Legal effect A treaty is only subject to international law and has no effect on the English legal system unless specific legislation is passed by the UK Parliament allowing the provisions of the Treaty to have such an effect. If there is the political will to translate any part of the treaty into English law this has to be specifically done by placing all, or part, of the treaty into legislation. Otherwise it merely remains a treaty at the international political level with absolutely no legal effects in the UK. It may, depending on its nature, be enforceable against Contracting States under international law. 5.3.1.3 Naming a treaty Every treaty has a formal name (which is usually abbreviated) and in addition many treaties are by custom referred to by the place where the treaty was signed! This can be confusing; check out the examples below in Figure 5.1, below. Figure 5.1: naming complexities 1 The Treaty on European Union 1992 (establishing the European Union) (a) Formal name: the Treaty on European Union 1992 (b) Abbreviation: TEU 1992 (c) Place of signing—Maastricht: It is therefore also called the Treaty of Maastricht. (Note: there was a second Treaty on European Union in 1997 (TEU 1997). Place of signature: Amsterdam, and referred to as the Treaty of Amsterdam. These similar names have to be distinguished by date and place of signature.) 2 The European Convention on Human Rights and Fundamental Freedoms 1951 (a) Formal name of treaty: The European Convention on Human Rights and Fundamental Freedoms. (b) Tends to be called The European Convention on Human Rights or the Convention. (c) Abbreviation: ECHR (d) Place of signature: London. But this is never used. (Note: this is an example of another word for treaty—a convention.)

2012 ◽  
pp. 129-129
Keyword(s):  
European Union ◽  
Human Rights ◽  
International Law ◽  
European Convention ◽  
Vienna Convention ◽  
The European Union ◽  
Fundamental Freedoms ◽  
Definition Of ◽  
The Uk ◽  
Treaty Of Amsterdam

E-Business Development Issues in UK SMEs

2003 ◽  
pp. 164-174
Author(s):  
Fiona Meikle ◽  
Dianne Willis
Keyword(s):  
Working Party ◽  
Business Development ◽  
Study Approach ◽  
Funding Sources ◽  
Factors Influencing ◽  
Definition Of ◽  
The Uk ◽  
Medium Enterprises ◽  
Industry Sectors

Using a case-study approach, this chapter aims to assess the development issues for e-business within small to medium enterprises (SMEs) in differing regions across the UK. The research documents the issues faced by three SMEs as they have embarked upon an e-business delivery. All of the case studies are SMEs that come from different industry sectors, but all have established an e-commerce service in the last 18 months. Our definition of e-commerce aligns with those principles set out by the Organisation for Economic Cooperation and Development (OECD) working party on Indicators for the Information Society WPIIS. The outcome is an evaluation and discussion of the underlying factors influencing each company’s progress within a regional UK framework. Issues raised in the study include lack of training and awareness in SMEs, the need for government-funded initiatives, reliance on personal networks, and a lack of clarity about funding sources and schemes.

scholarly journals Definition of Micro, Small and Medium Enterprise under the Guidelines of the European Union

2019 ◽  
Vol 12 (2) ◽  
pp. 165-190
Author(s):  
Monika Raczyńska
Keyword(s):  
European Union ◽  
Small And Medium Enterprises ◽  
Descriptive Analysis ◽  
Research Problem ◽  
The European Union ◽  
Effect Analysis ◽  
Medium Enterprise ◽  
Definition Of ◽  
Medium Enterprises

AbstractResearch problem: It should be remembered that projects co-financed from European Union funds are a special type of projects to which additional guidelines apply. Awareness of the regulation may help enterprises avoid erroneous categorization or loss of SME status resulting in non-awarding or reimbursement of subsidies with tax interest. The problem is still valid, because EU projects are and will be implemented and must preserve the so-called durability. The validity of the topic can be confirmed by the fact that definitional problems appear all the time, which are even dealt with in court.Thesis: The definition of micro, small and medium enterprises under the European Union guidelines requires special attention when applying for EU funding.The aim of the article is to present the issues related to the qualification of an entity to the category of micro, small and medium-sized enterprises in the context of using EU funds.The research methods were applied in the article: in the theoretical part – literature studies, comparative analysis, in the empirical part – case study, causal and effect analysis, descriptive analysis.

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