Consultation on Draft Regulations for an Integrated Authorisation Framework

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Publisher :
ISBN 13 : 9781788516082
Total Pages : 2 pages
Book Rating : 4.5/5 (16 download)

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Book Synopsis Consultation on Draft Regulations for an Integrated Authorisation Framework by :

Download or read book Consultation on Draft Regulations for an Integrated Authorisation Framework written by and published by . This book was released on 2018 with total page 2 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Legislative and Regulatory Framework

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Publisher :
ISBN 13 :
Total Pages : 38 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Legislative and Regulatory Framework by : Namibia Water Resources Management Review

Download or read book Legislative and Regulatory Framework written by Namibia Water Resources Management Review and published by . This book was released on 2000 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Combination Products Handbook

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Publisher : CRC Press
ISBN 13 : 1000874583
Total Pages : 439 pages
Book Rating : 4.0/5 (8 download)

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Book Synopsis The Combination Products Handbook by : Susan Neadle

Download or read book The Combination Products Handbook written by Susan Neadle and published by CRC Press. This book was released on 2023-05-16 with total page 439 pages. Available in PDF, EPUB and Kindle. Book excerpt: Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.

OECD Reviews of Regulatory Reform: Regulatory Reform in the Czech Republic 2001

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Publisher : OECD Publishing
ISBN 13 : 9264194819
Total Pages : 347 pages
Book Rating : 4.2/5 (641 download)

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Book Synopsis OECD Reviews of Regulatory Reform: Regulatory Reform in the Czech Republic 2001 by : OECD

Download or read book OECD Reviews of Regulatory Reform: Regulatory Reform in the Czech Republic 2001 written by OECD and published by OECD Publishing. This book was released on 2001-06-27 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: OECD's review of regulatory reform in the Czech Republic.

House of Commons - Science and Technology Committee: Clinical Trials - HC 104

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Publisher : The Stationery Office
ISBN 13 : 9780215062321
Total Pages : 210 pages
Book Rating : 4.0/5 (623 download)

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Book Synopsis House of Commons - Science and Technology Committee: Clinical Trials - HC 104 by : Great Britain: Parliament: House of Commons: Science and Technology Committee

Download or read book House of Commons - Science and Technology Committee: Clinical Trials - HC 104 written by Great Britain: Parliament: House of Commons: Science and Technology Committee and published by The Stationery Office. This book was released on 2013-09-17 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many of the trials taking place today are unregistered and unpublished, meaning that the information that they generate remains invisible to both the scientific community and the public. This undermines public trust, slowing the pace of medical advancement and potentially putting patients at risk. All trials conducted on NHS treatments-and all other trials receiving public funding-should be prospectively registered and their results published in a scientific journal. While the focus should be on implementing this change for future trials, the Government must also do what it can to ensure that historic trials are registered and published, particularly where they have been publically funded. The Government should also take steps to facilitate greater sharing of the raw data generated during a trial in a responsible and controlled way, with the knowledge and consent of patients. The report also draws attention to the recent fall in the number of trials taking place in the UK. It finds that the need for multiple governance approvals from participating NHS organisations remained the biggest barrier to setting up a UK trial, but that lack of public awareness was also a key issue. Recruiting participants can also be a challenge. The report calls on the Government to take its recommendations into account in ongoing discussions regarding the revision of European clinical trials legislation and in its response to the European Medicines Agency's consultation on the release of clinical trial data, which closes at the end of this month

Model Rules of Professional Conduct

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Publisher : American Bar Association
ISBN 13 : 9781590318737
Total Pages : 216 pages
Book Rating : 4.3/5 (187 download)

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Book Synopsis Model Rules of Professional Conduct by : American Bar Association. House of Delegates

Download or read book Model Rules of Professional Conduct written by American Bar Association. House of Delegates and published by American Bar Association. This book was released on 2007 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.

The Strategic Environmental Assessment Directive

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Publisher : Bloomsbury Publishing
ISBN 13 : 1782255524
Total Pages : 447 pages
Book Rating : 4.7/5 (822 download)

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Book Synopsis The Strategic Environmental Assessment Directive by : Gregory Jones KC

Download or read book The Strategic Environmental Assessment Directive written by Gregory Jones KC and published by Bloomsbury Publishing. This book was released on 2017-02-23 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Strategic Environmental Assessment Directive (Directive 2001/42/EC) (SEA Directive) has been a lurking legal presence in EU and UK environmental law. Now, just over a decade since its implementation, the impacts of the SEA Directive are beginning to be felt throughout the UK, and more broadly throughout the European Union as a whole. These developments have been driven both by the expansive interpretation of the Directive's scope by the Court of Justice of the European Union and by a slow learning process about how this new type of regulation should be legally interpreted and applied. This edited collection is the first volume to reflect comprehensively on the emerging legal identity of SEA in the EU and UK. With contributions addressing the impact of the SEA Directive on the fields of town and country planning and European environmental law, the book is a comprehensive analysis of all aspects of the Directive, from its history and scope, to its impact on governmental policy and its implications in practice. The volume both reflects on key cases such as Case C-567/10 Inter-Environnement Bruxelles and HS2, and looks forward, as it considers and projects future legal implications of the SEA Directive. Written by a blend of distinguished academics and leading practitioners, it provides an in-depth critique and rounded appreciation of both the immediate practical effects of SEA and its wider impact on European and UK environmental law.

The Oxford Handbook of Comparative Administrative Law

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Publisher : Oxford University Press
ISBN 13 : 0192560115
Total Pages : 1000 pages
Book Rating : 4.1/5 (925 download)

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Book Synopsis The Oxford Handbook of Comparative Administrative Law by : Peter Cane

Download or read book The Oxford Handbook of Comparative Administrative Law written by Peter Cane and published by Oxford University Press. This book was released on 2020-12-17 with total page 1000 pages. Available in PDF, EPUB and Kindle. Book excerpt: The comparative study of administrative law has a long history dating back more than 200 years. It has enjoyed a renaissance in the past 15 years or so and now sits alongside fields such as comparative constitutional law and global administrative law as a well-established area of scholarly research. This book is the first to provide a broad and systematic view of the subject both in terms of the topics covered and the legal traditions surveyed. In its various parts it surveys the historical beginnings of comparative administrative law scholarship, discusses important methodological issues, examines the relationship between administrative law and regime type, analyses basic concepts such as 'administrative power' and 'accountability', and deals with the creation, functions, and control of administrative power, and values of administration. The final part looks to the future of this young sub-discipline. In this volume, distinguished experts and leaders in the field discuss a wide range of issues in administrative law from a comparative perspective. Administrative law is concerned with the conferral, nature, exercise, and legal control of administrative (or 'executive') governmental power. It has close links with other areas of 'public law', notably constitutional law and international law. It is of great interest and importance not only to lawyers but also to students of politics, government, and public policy. Studying public law comparatively helps to identify both similarities and differences between the way government power and its control is managed in different countries and legal traditions.

Integrated Management Tools in the Heritage of South-East Europe

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Publisher : Council of Europe
ISBN 13 : 9789287162649
Total Pages : 288 pages
Book Rating : 4.1/5 (626 download)

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Book Synopsis Integrated Management Tools in the Heritage of South-East Europe by : Rob Pickard

Download or read book Integrated Management Tools in the Heritage of South-East Europe written by Rob Pickard and published by Council of Europe. This book was released on 2008-01-01 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: As part of the Institutional Capacity Building Plan, which is the first of the three components of the Regional Programme for Cultural and Natural Heritage in South-East Europe launched in 2003, a "transnational theme-based debate" was organised. The second step in this debate stemmed from an assessment of requests from the countries/regions participating in the Regional Programme: Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Kosovo/ UNMIK, Montenegro, Romania, Serbia and "the former Yugoslav Republic of Macedonia".The first step was concerned with current heritage policies and legislation. Its aim was to take stock of the position regarding legislative reforms and heritage policies in the countries of South-East Europe. It also highlighted the need for an in-depth analysis of certain key areas where difficulties still arose in implementation.The second step was concerned with tools for integrated management of the cultural and natural heritage, in the broad sense of the term "heritage" (the concept of cultural environment). It linked together three key topics previously identified: documentation systems, incorporating the heritage dimension in environment, regional development and town planning documents, permits, controls and penalties related to heritage conservation work.

Case Studies on Access and Benefit-sharing

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Publisher : Bioversity International
ISBN 13 : 9290437219
Total Pages : 178 pages
Book Rating : 4.2/5 (94 download)

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Book Synopsis Case Studies on Access and Benefit-sharing by :

Download or read book Case Studies on Access and Benefit-sharing written by and published by Bioversity International. This book was released on with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Spaceports in Europe

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Publisher : Springer Nature
ISBN 13 : 3030883116
Total Pages : 156 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Spaceports in Europe by : Annette Froehlich

Download or read book Spaceports in Europe written by Annette Froehlich and published by Springer Nature. This book was released on 2022-01-01 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores how Europe is seeking to enlarge its launching capacities by building additional spaceports on the European continent. Various national initiatives are envisaged resulting in a “space race” in the field of constructing spaceports and building micro launchers. However, right from the beginning when choosing the launch site (land or sea based-rocket launches) there are various factors relating to international space law, European regulations and national rules that must be considered, as spaceports are rarely explicitly addressed in current legal and policy frameworks. While launching sites used to be operated by governments, private commercial initiatives are increasingly entering the field. This paradigm shift must be reflected within regulations relating to various aspects of space liability by enlarging the long-established terms of the United Nations space treaties to accommodate commercial space flights. Questions of permission, supervision and control require special liability regulations to avoid detrimental consequences stemming from the concept of “launching states” in view of the rise of private driven commercial space activities on a global level. Furthermore, not only do environmental aspects need to be thoroughly examined but also the concept of critical infrastructure requires special attention from a security perspective to anticipate, inter alia, cyber-attacks. For these reasons, several European and national regulations may need to be enlarged to apply to the entire space sector, using a harmonized approach that has direct implications for the regulations, programmes, and missions of the European Union and the European Space Agency, bearing in mind that the upcoming spaceports in Europe are an essential asset to substantially boost the European New Space.

Citizens as Partners Information, Consultation and Public Participation in Policy-Making

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Publisher : OECD Publishing
ISBN 13 : 9789264195561
Total Pages : 253 pages
Book Rating : 4.1/5 (955 download)

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Book Synopsis Citizens as Partners Information, Consultation and Public Participation in Policy-Making by : OECD

Download or read book Citizens as Partners Information, Consultation and Public Participation in Policy-Making written by OECD and published by OECD Publishing. This book was released on 2001-10-11 with total page 253 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines a wide range of country experiences, offers examples of good practice, highlights innovative approaches and identifies promising tools (including new information technologies)for engaging citizens in policy making. It proposes a set of ten guiding principles.

Environmental Performance Reviews

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Publisher : Environmental Performance Revi
ISBN 13 :
Total Pages : 260 pages
Book Rating : 4.:/5 (1 download)

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Book Synopsis Environmental Performance Reviews by :

Download or read book Environmental Performance Reviews written by and published by Environmental Performance Revi. This book was released on 2010 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the second EPR of Georgia published by UNECE. The report takes stock of the progress made by Georgia in the management of its environment since the country was first reviewed in 2001. It assesses the implementation of the recommendations in the first review (Annex I). It also covers nine issues of importance to Georgia concerning policymaking, planning and implementation, the financing of environmental policies and projects, and the integration of environmental concerns into economic sectors, in particular water management, waste management, risk management and forestry. The main outcome of the EPR is the recommendations, which were elaborated by the Expert Group, peer reviewed, discussed with a high-level delegation from Georgia and adopted by the UNECE Committee on Environmental Policy on 15 March 2010.

White Paper on Integrated Pollution and Waste Management for South Africa

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Publisher :
ISBN 13 :
Total Pages : 66 pages
Book Rating : 4.:/5 (8 download)

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Book Synopsis White Paper on Integrated Pollution and Waste Management for South Africa by : South Africa. Department of Environmental Affairs and Tourism

Download or read book White Paper on Integrated Pollution and Waste Management for South Africa written by South Africa. Department of Environmental Affairs and Tourism and published by . This book was released on 2000 with total page 66 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Building Integrated Markets within the East African Community

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Publisher : World Bank Publications
ISBN 13 : 1464802289
Total Pages : 159 pages
Book Rating : 4.4/5 (648 download)

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Book Synopsis Building Integrated Markets within the East African Community by : World Bank World Bank

Download or read book Building Integrated Markets within the East African Community written by World Bank World Bank and published by World Bank Publications. This book was released on 2014-06-16 with total page 159 pages. Available in PDF, EPUB and Kindle. Book excerpt: A report, requested by the East African Community (EAC) Secretariat, that provides an assessment and recommendations as to policy, legal, institutional and financial product actions the EAC could take to promote increased private investment in the Community s regional infrastructure.

Marine Renewable Energy

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Publisher : Springer
ISBN 13 : 3319535366
Total Pages : 396 pages
Book Rating : 4.3/5 (195 download)

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Book Synopsis Marine Renewable Energy by : Zhaoqing Yang

Download or read book Marine Renewable Energy written by Zhaoqing Yang and published by Springer. This book was released on 2017-04-24 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This complete reference to marine renewable energy covers aspects of resource characterization and physical effects of harvesting the ocean’s vast and powerful resources—from wave and tidal stream to ocean current energy. Experts in each of these areas contribute their insights to provide a cohesive overview of the marine renewable energy spectrum based on theoretical, numerical modeling, and field-measurement approaches. They provide clear explanations of the underlying physics and mechanics, and give close consideration to practical implementation aspects, including impacts on the physical system. Engineers, researchers, and students alike will find invaluable tools and studies that will aid them in realizing significant sustainable energy production from near-shore and ocean environments.

Regulation, Enforcement and Governance of Environmental Law

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Author :
Publisher : Cameron May
ISBN 13 : 1905017642
Total Pages : 766 pages
Book Rating : 4.9/5 (5 download)

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Book Synopsis Regulation, Enforcement and Governance of Environmental Law by : Richard Macrory

Download or read book Regulation, Enforcement and Governance of Environmental Law written by Richard Macrory and published by Cameron May. This book was released on 2008 with total page 766 pages. Available in PDF, EPUB and Kindle. Book excerpt: