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Книги з теми "GMP EU"

Автор: Grafiati

Опубліковано: 30 травня 2022

Оновлено: 31 травня 2022

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1

Costa, Marios. The Accountability Gap in EU law. Abingdon, Oxon; New York, NY: Routledge, 2017. |: Routledge, 2016. http://dx.doi.org/10.4324/9781315675077.

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2

Bolt, W. Output gap and inflation in the EU. Amsterdam: De Nederlandsche Bank, 2000.

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3

Ferragina, Anna Maria. Mind the gap: Unemployment in the new eu regions. Bonn, Germany: IZA, 2005.

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4

Barbone, Luca. EU accession of Central and Eastern Europe: Bridging the income gap. Washington, DC: World Bank, Country Dept. II, Europe and Central Asia Division, 1997.

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5

Handoll, John. Protecting national interests: Bridging the gap between member states and EU policies. West Sussex [England]: J. Wiley & Sons, 1997.

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6

Block, Ludo. From politics to policing: The rationality gap in EU Council policy-making. The Hague, The Netherlands: Eleven International Publishing, 2011.

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7

Plana Casado, Maria Jose. E-FOOD: Closing the Online Enforcement Gap in the EU Platform Economy. Cham: Springer International Publishing, 2021. http://dx.doi.org/10.1007/978-3-030-79504-7.

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8

Stephan, Johannes. EU-integration and development prospects of CEECs: The productivity-gap and technological structural change. Halle: Institut für Wirtschaftsforschung Halle, 2001.

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9

Eck, Roelien Ritsema Van. Bridging the gap; research into the relationship between EU SME policies and SME consultancy firms operating in the Netherlands. Oxford: Oxford Brookes University, 1999.

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10

Bailey, Allen R. The EU GMP: Good manufacturing practices. International Quality Press, 1997.

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11

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP. Taylor & Francis Group, 2015.

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12

Lopez, Orlando. EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP. CRC Press, 2015. http://dx.doi.org/10.1201/b18315.

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13

Bailey, Allen R. EU GLP: Good laboratory practices. International Quality Press, 1997.

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14

Costa, Marios. Accountability Gap in Eu Law. Taylor & Francis Group, 2020.

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15

Bernitz, Ulf, Thomas Persson, Moa Mårtensson, and Lars Oxelheim. Bridging the Prosperity Gap in the EU. Edward Elgar Publishing, 2018. http://dx.doi.org/10.4337/9781786436672.

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16

Daly, Angela. Private Power, Online Information Flows and EU Law: Mind the Gap. Bloomsbury Publishing Plc, 2016.

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17

Barbone, Luca, and Juan Zalduendo. EU Accession of Central and Eastern Europe: Bridging the Income Gap. The World Bank, 1999. http://dx.doi.org/10.1596/1813-9450-1721.

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18

Grimm, Dieter. Europe, Yes—But Which Europe? Oxford University Press, 2017. http://dx.doi.org/10.1093/oso/9780198805120.003.0001.

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Анотація:

This chapter suggests that the European Union has outgrown the original economic community but it remains unclear what it should become in the end. It first explains how the European Economic Community, the forerunner of the EU, became a singular, supranational entity somewhere between an international organization and a federal state. It then examines the 1992 Treaty of Maastricht; how EU’s democracy problem is exacerbated by a yawning gap between decision-making power and accountability; and the European Court of Justice’s role in the economic integration process as well as its interpretation of the European treaties. It also discusses proposals for an institutional reform of the EU, such as enhancing the representation of EU citizens on the European Parliament. Finally, it considers plausible explanations of European integration and how the EU must be arranged so as to find greater acceptance.

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19

Dyker, David A. Closing the Eu East-west Productivity Gap: Foreign Direct Investment, Competitiveness And Public Policy. Imperial College Press, 2006.

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20

Curtin, Deirdre. Mind The Gap: The Evolving Eu Executive And The Constitution (Walter Van Gerven Lectures). Europa Law Pub Netherlands, 2005.

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21

Herrmann, Christoph, ed. Die gemeinsame Handelspolitik im Europäischen Verfassungsverbund. Nomos Verlagsgesellschaft mbH & Co. KG, 2020. http://dx.doi.org/10.5771/9783845298153.

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Анотація:

Die gemeinsame Handelspolitik (GHP) der Europäischen Union (EU) rückte zuletzt immer häufiger in den Mittelpunkt medialer Aufmerksamkeit. Der vorliegende Tagungsband setzt eine Reihe GHP-bezogener Bände fort und geht der Frage nach, inwieweit die GHP nach den umfangreichen Reformen im Rahmen des Vertrags von Lissabon einen geeigneten verfassungsrechtlichen Rahmen für die internationale Handelspolitik im 21. Jahrhundert bildet. Im Ergebnis zeigt sich, dass die Konstitutionalisierung der GHP durch den Vertrag von Lissabon eher asymmetrische Züge aufweist: Während die demokratische Rückbindung massiv ausgeweitet wurde, führt u. a. die fortgesetzte Ablehnung einer unmittelbaren Wirkung von Handelsabkommen zu einer Schwächung rechtsstaatlicher Elemente. Das entspricht dem Trend einer allgemein stärkeren Betonung national-staatlicher Souveränitätsrechte rund um den Globus, stellt aus verfassungsrechtlicher Perspektive gleichwohl einen Rückschritt oder zumindest das Fehlen von Fortschritt dar.

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22

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Role and responsibilities of the sponsor. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0012.

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Анотація:

This chapter discusses the definitions of a clinical trial sponsor and the roles and responsibilities that it comprises. The aim is to give an overall picture of the role and legal responsibilities and to focus on the systems required for successfully undertaking the role of sponsor. The sponsor is critical, as without a sponsor, a study may not proceed. Sponsor responsibilities are very broad, encompassing overall responsibility for many different trial related activities. These are detailed in GCP guidelines, the EU Directives, the EU Regulation and national regulations. Key areas include authorisations/approvals (including indemnity, insurance and compensation arrangements), financing of the study, conduct of the study to GCP standards, provision of quality systems including SOPs and auditing, manufacture and provision of investigational medicinal product and safety information. Sponsors will therefore require systems to cover these key areas. While activities may be delegated, the sponsor retains overall responsibility, so adequate oversight is required to ensure that these activities are completed to appropriate standards.

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23

Taylor-Gooby, Peter, Benjamin Leruth, and Heejung Chung. Where Next for the UK Welfare State? Oxford University Press, 2017. http://dx.doi.org/10.1093/oso/9780198790266.003.0003.

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Анотація:

The liberal-leaning UK welfare state is contracting due to a sharp austerity programme. It is failing to address the challenges of population ageing and globalized competition. Increasingly provision is divided between maintained benefits for pensioners (rising in real terms) and those for working age people (harshly cut back). This gap has been exploited by the Conservative Party for political advantage, leading to a deepening of social divisions. At the same time concerns about immigration are leading to popular demands for a protectionist stance by government. In the 2016 referendum, these culminated in a vote to leave the EU. Brexit is currently being implemented, with damaging consequences for the UK economy, possibly triggering further EU fragmentation.

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24

Perrone, Andrea. Small and Medium Enterprises Growth Markets. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780198813392.003.0012.

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Анотація:

In accordance with the EU's traditional focus on small and medium-sized enterprises (SME) financing and its more recent attempt to support SME access to capital markets, Directive 2014/65/EU (MiFID II) has introduced the new category of SME Growth Markets (GMs). Aimed at preserving the status quo, in which SMEs prefer second-tier exchange-regulated markets, typically in the form of multilateral trading facilities (MTFs), the MiFID II rules employ a ‘light touch’ approach. Under the new regime SME GMs: (1) constitute an optional feature of the MTF regime intended to result in a ‘specific quality label’, and (2) are subject to the rules established by each Member State as applied by the local national competent authority, within the very broad framework provided by MiFID II. This chapter argues that the MiFID II regulation pertaining to SME GMs represents a missed opportunity, if not a source of potential harm to the capital-raising efforts of SMEs.

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25

Emir, Astra. Selwyn's Law of Employment. Oxford University Press, 2018. http://dx.doi.org/10.1093/he/9780198814849.001.0001.

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Анотація:

Selwyn’s Law of Employment is regarded as essential reading by law students and practising lawyers, and those studying employment law in a business or professional environment. This edition continues Norman Selwyn’s practical approach to the subject providing a succinct account of all areas of employment law. Both individual and collective employment law issues are considered, alongside a broad range of UK and EU case law. New to this edition, the text provides coverage of new legislation including the Trade Union Act 2016, the Immigration Act 2016, and the Equality Act 2010 (Gender Pay Gap Information) Regulations 2017employment law.

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26

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Setting the scene and ICH GCP in clinical and healthcare research. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0008.

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Анотація:

This chapter looks at the purpose and history of the development of good clinical practice (GCP). The international conference on harmonisation (ICH) GCP is the international quality standard for conducting clinical research to ensure the rights and well-being of patients are protected and the resulting data are valid. The cornerstone of ethics in research stems from the Declaration of Helsinki and the chapter looks at the changes in the Declaration and the impact on clinical trials. The development of the ICH process is described and the E, S, Q and M guidelines are discussed, The efficacy guidelines affect the practical aspects of trials and the efficacy guideline number 6 (E6) is on GCP. The content of the E6 guidelines is reviewed including the responsibilities of ethics committees, investigator and sponsor. Documentation requirements including the Protocol and Investigator Brochure as well as all the other documents are outlined. The guidelines are written to be interpreted and companies and institutions have to document their interpretation using standard operating procedures (SOPs). Although ICH GCP is regarded as the world-wide standard it sits alongside countries' legislation. In Europe CTIMPs have to follow the EU Directives and Regulation. Non pharmaceutical/non interventional healthcare research has no legal requirements to adhere to ICH GCP and is carried out under different research governance frameworks (RGF), however they all have their principles based on ICH GCP. The chapter also discusses the definition of an IMP and the decisions and processes that have to be followed when conducting non CTIMP studies.

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27

Beyer, Helge. Kosten-Nutzen-Analytische Beurteilung Der Auswirkungen Der Gap-Reform 2003 Auf Den Eu-Getreidesektor (Europaische Hochschulschriften: Reihe 5, Volks - Und Betrieb). Peter Lang Publishing, 2005.

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28

Cabrelli, David. 14. Equal Pay Law. Oxford University Press, 2018. http://dx.doi.org/10.1093/he/9780198813149.003.0014.

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Анотація:

This chapter examines the principle of equal pay for equal work enshrined in the Equality Act 2010 (EA). It first considers the stubbornness of the gender pay gap in the UK and the EU, as well as the justifications for intervention in the labour market via the auspices of equal pay laws. It goes on to discuss the legal machinery in the EA, which confers an entitlement on employees of one sex to the same remuneration as suitable employee comparators of the opposite sex. The focus then turns to the content of the ‘sex equality clause’—a term imposed into every employee’s contract of employment by virtue of section 66 of the EA. This is followed by a discussion of the material factor defence for employers in section 69 of the EA.

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29

Riches, Christopher, and Peter Stalker. A Guide to Countries of the World. Oxford University Press, 2016. http://dx.doi.org/10.1093/acref/9780191803000.001.0001.

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Анотація:

Over 240 entriesThis invaluable A–Z provides a wealth of up-to-date information on every country in the world, including dependent territories. Each entry provides a brief history of the country and outlines its political, economic, and social issues. A quick-reference fact box provides comparative information on land area, people, language, religion, life expectancy, GDP, and gender equality and environmental performance. Invaluable supplementary material includes detailed indicator tables showing income and poverty, health and population, and a list of international organizations, such as the EU and the African Union, with essential information about these groupings.This accessible guide is an ideal reference for students and teachers of geography, politics, economics, and world history at all levels, as well as anyone wanting access to reliable information on any country of the world.

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30

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Essential documents. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0022.

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Анотація:

It is a legal requirement for sponsors and investigators to maintain essential documentation. This chapter outlines the ICH GCP E6 requirements for documentation before, during and after the study. It describes each document and its purpose in the study. The chapter also describes how to deal with additional documentation kept by sponsors and sites but not addressed in the guidelines e.g. correspondence, emails and notes to file, The organisation of the trial master file (TMF) is not defined in guidelines but many companies and institutions will have a filing system described in SOPs, most are numeric and an example content list is given. The TMF must be maintained and stored correctly and version control of documentation is vital to maintain the audit trail. The legislation does not distinguish between commercial and non-commercial/academic studies but researchers are expected to adhere to the principles of GCP and maintain the TMF requirements. Originally TMF were paper based but the eTMF is now widely used by commercial sponsors. The retention time for the TMF has changed on a number of occasions the EU Regulation clearly states that essential documentation must be kept for 25 years and must be readily available for inspection.

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31

Bongini, Paola, Annalisa Ferrando, Emanuele Rossi, and Monica Rossolini. The Capital Markets Union and Firms’ Access to External Market-Based Finance. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780198815815.003.0013.

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Анотація:

Firms’ access to capital markets among Eurozone countries is a challenging issue for the EU Capital Markets Union (CMU) agenda. We contribute to the current debate on the CMU by identifying the characteristics of firms that can be deemed ‘suitable’ for market-based finance. Using survey-based research, we show which firm-specific attributes and country-specific features foster a firm’s likelihood of accessing non-bank sources of finance. Our results reveal that a few Eurozone countries appear to have achieved high access to capital market financing, but there is substantial unexploited potential among firms fit for market-based finance. Our research also indicates that the macro business environment and conditions—such as GDP growth, the degree of development of domestic financial markets, and the quality of the legal and judicial enforcement system—significantly impact firms’ market suitability. Our results therefore can be linked to a number of goals of the CMU Action Plan.

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32

Guido, Ferrarini, and Saguato Paolo. Part III Trading, 11 Governance and Organization of Trading Venues: The Role of Financial Market Infrastructure Groups. Oxford University Press, 2017. http://dx.doi.org/10.1093/law/9780198767671.003.0011.

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Анотація:

This chapter shows that MiFID II brings modest changes to trading venues in the EU: newly introduced Organized Trading Facilities (OTFs) will be the reference venues for a significant portion of derivatives trading; and regulated markets (RMs) and Multilateral Trading Facilities (MTFs) regimes have been aligned, with specific provisions to strengthen the governance of venues and operators. However, trading venues which have developed into Financial Markets Infrastructures (FMI) groups providing trading and post-trading services test the capacity of the current regime—and MiFID II itself—to oversee their activities and guarantee competition and stability. MiFID II does not explicitly take FMI groups into account; only three sets of rules address some of their potential risks. The authors conclude that this regulatory gap might threaten financial market stability, and regulators should consider a regulatory intervention, such as the experience of the regulatory and supervisory colleges of CCPs under EMIR and the regulatory framework of the financial conglomerates directive.

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33

Application of the intervention Best-practices with rural NEETs. CA 18213: Rural NEET Youth Network: Modeling the risks underlying rural NEETs social exclusion, 2022. http://dx.doi.org/10.15847/cisrnyn.babpneets.2022.05.

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Анотація:

Relatively few studies have investigated the strategies, policies, programmes, and projects concerning rural NEETs (namely, young people living in rural areas neither in employment nor in education or training). This special issue of Quality of Life Jour- nal is dedicated to fulfilling this gap in the literature. It contributes case studies from European Union (EU) member states. The primary purpose of this special issue is to approach and discuss the various strategies, policies, programmes, and projects appli- cable to youth rural NEETs. This special issue edition has sought to gather research papers (or critical, theoretical analysis on selected topics) covering NEETs strategies, policies, measures, programmes, and projects. These highlight the success factors and scope for transferability of good (or, how to avoid bad) practices. To that end, they examine pertinent labour market and NEET situations which can help to explain the context, reasons, and baseline for the various strategies and policy measures being implemented. They also cover assessment of NEET strategies by focusing on formal education, training and skills development, and active employment policies, in particular the role of Youth Guarantee in local/rural employment. Various other relevant factors are considered/examined, including: assessment of the NEET policy measures and results; objectives, target groups, geographical and sectoral scope in different economic activities, financial, legal and institutional frameworks; results and lessons learned, including adaptations due to crisis; domestic and international programmes, as well as numerous projects and instruments; difficulties and constraints; and, finally, assessment of the success factors and transferability of projects and strategies thereof

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34

Laurie, Graeme, Shawn Harmon, and Edward Dove. Mason and McCall Smith's Law and Medical Ethics. Oxford University Press, 2019. http://dx.doi.org/10.1093/he/9780198826217.001.0001.

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Анотація:

This textbook has provided a framework for exploring medical law and ethics for more than 35 years. It provides extensive examination of the interrelationship between ethical medical practice and the law. The authors offer their own opinions on current debates and controversies, and encourage readers to formulate their own views and arguments. Medical law is significantly shaped by the courts, and this book provides extensive coverage of recent judicial decisions as well as statutory developments. This eleventh edition continues to take a comparative approach, as in the case of assisted suicide, and also on the growing influence of international instruments and collaborations, as demonstrated in the field of health research. Despite the prospect of Brexit, the book continues to offer a dedicated and in-depth chapter on the influence of EU law on the field. The book is essential reading for any serious medical law student or practitioner, as well as being of interest to all those involved in the delivery and regulation of modern health care. New or updated material includes: a new chapter bringing together the range of ethico-legal issues affecting children, including minors and consent, data protection and research with children; detailed discussion of the high-profile court decisions involving Charlie Gard and Alfie Evans regarding medically futile treatment of infants; consideration of the Supreme Court ruling in Darnley v Croydon Health Services and the implications for A&E departments and their duty of care to patients; discussion of updated GMC guidance on Confidentiality (2017); fully updated discussion of the case law and changes in regulation of international surrogacy; and consideration throughout of the of the General Data Protection Regulation, which came in May 2018.

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