Download or read book Medical Data Sharing Harmonization and Analytics written by Vasileios Pezoulas and published by Academic Press. This book was released on 2020-01-05 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Data Sharing, Harmonization and Analytics serves as the basis for understanding the rapidly evolving field of medical data harmonization combined with the latest cloud infrastructures for storing the harmonized (shared) data. Chapters cover the latest research and applications on data sharing and protection in the medical domain, cohort integration through the recent advancements in data harmonization, cloud computing for storing and securing the patient data, and data analytics for effectively processing the harmonized data. - Examines the unmet needs in chronic diseases as a part of medical data sharing - Discusses ethical, legal and privacy issues as part of data protection - Combines data harmonization and big data analytics strategies in shared medical data, along with relevant case studies in chronic diseases
Download or read book Harmonization of Leaching Extraction Tests written by L. Heasman and published by Elsevier. This book was released on 1997-06-10 with total page 293 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a unique compilation on the use of leaching/extraction methods in different fields. The use of leaching test methods is increasing in various areas including: waste treatment and disposal; incineration of waste; soil clean-up and reuse of cleaned soil; sludge treatment. This has led to (and may increasingly lead to) the development of a large number of very similar tests in these different fields. However, these developments are taking place with no clear understanding of their mutual relationships. In view of these developments, efforts are needed to harmonize the leaching procedures that could be adapted for different matrices, as well as validate the use of existing tests in other fields. The development of a wide variety of leaching/extraction tests for different matrices is undesirable from a regulatory point of view and undesirable for industry. Clarity in testing is crucial in producer-consumer relations. This collective document will assist in improving the understanding of leaching from a variety of sources and will, where appropriate, help to bring together the approaches used in different technical fields and in different countries.
Download or read book Strategic Scientific and Medical Writing written by Pieter H. Joubert and published by Springer. This book was released on 2015-11-27 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: A document may be based on accurate medical and scientific information, follow guidelines precisely, and be well written in clear and correct language, but may still fail to achieve its objectives. The strategic approach described in this book will help you to turn good medical and scientific writing into successful writing. It describes clearly and concisely how to identify the target audience and the desired outcome, and how to construct key messages for a wide spectrum of documents. Irrespective of your level of expertise and your seniority in the pharmaceutical, regulatory, or academic environment, this book is an essential addition to your supporting library. The authors share with you many years of combined experience in the pharmaceutical and academic environment and in the writing of successful outcome-driven documents.
Download or read book Handbook of Transnational Economic Governance Regimes written by Christian Tietje and published by BRILL. This book was released on 2009-10-14 with total page 1105 pages. Available in PDF, EPUB and Kindle. Book excerpt: Non-governmental organizations, transnational business associations, private standard-setting bodies, public-private partnerships, and institutionalized incentive schemes now occupy a central place in the regulation and governance of transnational economic affairs alongside states and intergovernmental organizations. Much of the literature on these new and emerging patterns of governance has focused on the legal, political, and normative implications of this rapidly evolving landscape. The Handbook of Transnational Economic Governance Regimes expands on this scholarship by identifying, describing, and analysing more than 85 of the most significant actors in transnational governance. The Handbook examines the origins, evolution, structure, membership, financing, and strategies of key organizations and regulatory networks in almost every sphere of global economic activity, and analyses their role and influence in contemporary transnational economic governance.
Download or read book From Dual to Cooperative Federalism written by Robert Schütze and published by OUP Oxford. This book was released on 2013-01-31 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: What is the federal philosophy inspiring the structure of European law? The federal principle stands for constitutional arrangements that find "unity in diversity". The two most influential manifestations of the federal principle emerged under the names of "dual" and "cooperative" federalism in the constitutional history of the United States of America. Dual federalism is based on the idea that the federal government and the State governments are co-equals and each is legislating in a separate sphere. Cooperative federalism, on the other hand, stands for the thought that both governments legislate in the same sphere. They are hierarchically arranged and complement each other in solving a social problem. Can the European Union be understood in federal terms? The book's general part introduces three constitutional traditions of the federal idea. Following the American tradition, the European Union is defined as a Federation of States as it stands on the "middle ground" between international and national law. But what federal philosophy has the European Union followed? The special part of the book investigates the structure of European law. Three arguments are advanced to show the evolution of the European legal order from dual to cooperative federalism. The first looks at the decline of constitutional exclusivity on the part of the Member States and the European Union. For almost all objects of government, the Union and its States operate in a universe of shared powers. The second argument analyses the decline of legislative exclusivity. European and national legislation - increasingly - complement each other to solve a social problem. The third argument describes the "constitutionalisation" of cooperative federalism in the form of the principle of subsidiarity and the idea of complementary competences. A final Chapter is dedicated to Europe's foreign affairs federalism. It analyses, whether the external sphere must be regarded as subject to different constitutional or federal principles. The book concludes that cooperative federalism will benefit both levels of government - the Union and the Member States - as the constitutional mechanism of uniform European standards complemented by diverse national standards best expresses the federal idea of "unity in diversity".
Download or read book International Cooperation Convergence and Harmonization of Pharmaceutical Regulations written by Pierre-Louis Lezotre and published by Academic Press. This book was released on 2013-12-05 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective provides the current status of the complex and broad phenomenon of cooperation, convergence and harmonization in the pharmaceutical sector (Part I), thoroughly evaluates its added value and its critical parameters and influencing factors (Part II) in order to recommend actions and measures to support the next steps for cooperation, convergence and harmonization (Part III). All of these recommendations in the book support the establishment of a better coordinated global pharmaceutical system which represents the best realistic alternative to fulfill the objective to establish a global coalition of regulators and to respond to an increased demand to further cooperation in the pharmaceutical sector. This proposed framework, which leverages all of the ongoing positive cooperation initiatives and uses as foundations all of the numerous harmonization projects developed over the years, presents advantages for all stakeholders and would definitively have significant added value to the promotion and protection of global public health. The status of all major worldwide harmonization and cooperation initiatives (at bilateral, regional, and global levels) The value of cooperation in the pharmaceutical sector and the driving factors behind harmonization The proposition of a structure for the global pharmaceutical system and timely recommendations for enhancing international cooperation, as well as further discussion and policy changes in this area
Download or read book Specification of Drug Substances and Products written by Christopher M. Riley and published by Newnes. This book was released on 2013-08-21 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them. - Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD) - Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authorities - Direct applicability to the day-to-day activities in drug development and the potential to increase productivity
Download or read book Survey Methods in Multinational Multiregional and Multicultural Contexts written by Janet A. Harkness and published by John Wiley & Sons. This book was released on 2010-04-30 with total page 620 pages. Available in PDF, EPUB and Kindle. Book excerpt: A unique collaboration featuring the latest methodologies and research on multi- and cross-national surveys Over the past two decades, the relevance of cross-national and cross-cultural methodologies has heightened across various fields of study. Responding to increasing cultural diversity and rapid changes in how research is conducted, Survey Methods in Multinational, Multiregional, and Multicultural Contexts addresses the need for refined tools and improved procedures in cross-cultural and cross-national studies worldwide. Based on research submitted to the International Conference on Multinational, Multicultural, and Multiregional Survey Methods (3MC), this book identifies important changes in comparative methodology approaches, outlines new findings, and provides insight into future developments in the field. Some of the world's leading survey researchers gather in this volume to address the need for a standard framework that promotes quality assurance and quality control in survey research, and its impact on various stages of the survey life cycle, including study design and organization, cross-national sampling, testing and pretesting, data collection, and input and output variable harmonization. Self-contained chapters feature coverage of various topics, such as: Question and questionnaire design, from both global and study-specific perspectives The construction and evaluation of survey translations and instrument adaptations The effects of cultural difference on the perception of question and response categories Non-response issues Analysis in comparative contexts, featuring discussion of polytomous item response theory, categorization problems, and Multi-Trait-Multi-Methods (MTMM) The significance of evolving methodologies for current international survey programs, including the European Social Survey, the International Social Survey Programme, and the Gallup World Poll Survey Methods in Multinational, Multiregional, and Multicultural Contexts is a valuable supplement for courses on comparative survey methods at the upper-undergraduate and graduate levels. It also serves as an insightful reference for professionals who design, implement, and analyze comparative research in the areas of business, public health, and the social and behavioral sciences.
Download or read book Summary Technical Report of NDRC written by United States. Office of Scientific Research and Development. National Defense Research Committee and published by . This book was released on 1946 with total page 790 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Harmonization Equivalence and Mutual Recognition of Standards in WTO Law written by Humberto Zúñiga Schroder and published by Kluwer Law International B.V.. This book was released on 2011-07-01 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: Standards are a feature of virtually all areas of trade in products and services. Yet, although standards may achieve an efficient economic exchange, they have discriminatory consequences for trading partners when governments formulate or apply them in such a way as to cause obstacles to trade, thus enrolling standards among the increasingly significant ‘non-tariff barriers’ regulated by the WTO. This unique and original study analyses the functions that standards fulfil in the market, their effect on trade, and the legal regime based on harmonization, equivalence and mutual recognition developed by the WTO to deal with standards. The author investigates the way in which both the WTO Technical Barriers to Trade (TBT) and the Sanitary and Phytosanitary (SPS) Measures Agreements regulate these three tools, and discusses key topics including: The definition of the concept ‘International Standard’ in the TBT Agreement. Guidelines on equivalence issued by organizations such as the Codex Alimentarius Commission, the World Organization for Animal Health and the International Plant Protection Convention. Parallels between the EC mutual recognition regime and the WTO system. This is the first work on its subject. With its detailed and practical analysis of WTO law on standards, the book is a fundamental reference for practitioners, academics and policy makers in international trade law.
Download or read book The Pluralist Character of the European Economic Constitution written by Clemens Kaupa and published by Bloomsbury Publishing. This book was released on 2016-08-25 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: This monograph intervenes in the long-standing and controversial debate on the socio-economic orientation of the European Union. Arguing that the European economic constitution is pluralist in the sense that it does not favour any specific socio-economic paradigm, it shows that European law allows the pursuit of very different regulatory projects by the European and the national legislators. This pluralist character of the European economic constitution stands in an uncomfortable relationship with the policies currently pursued by the European Union, which are often neoliberal in their orientation. The book takes an interdisciplinary approach: it analyses the Treaty on the Functioning of the European Union as interpreted and developed in the case law of the Court of Justice, its history, and its regulatory purpose in the light of conflicting socio-economic paradigms. By challenging the orthodoxy, the book makes a bold proposition that will likely resonate in both European economic law scholarship and European law in general. With the ongoing economic crisis triggering a significant interest in economic questions among legal scholars it is particularly timely and topical.
Download or read book USITC Publication written by and published by . This book was released on 1991 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Intelligent Transport Systems Standards written by Bob Williams and published by Artech House. This book was released on 2008 with total page 836 pages. Available in PDF, EPUB and Kindle. Book excerpt: To list, summarize, and categorize intelligent transportation standards (ITS). Reviews best practices and provides listings for standards developing organizations at national and international levels. Provides guidance as to where to look in the furute to find relevant standards for ITS. Presents strategies for integrating standards in IRS planning, deployment, and operation.
Download or read book EU Constitutional Law written by Koen Lenaerts and published by Oxford University Press. This book was released on 2021-12-17 with total page 1025 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title is a comprehensive textbook of EU constitutional law, setting out the structure, values, procedures, and policies of the European Union. It is a first point of reference for issues of EU constitutional law. The book encompasses six major parts. It contains an extensive analysis of the key constitutional principles governing the exercise of competences by the Union and the balance of power between the Union and its Member States, followed by an in-depth anaylsis of EU citizenship and the four freedoms, followed by an overview of the main internal and external policy domains. The third part addresses the role and workings of the various institutions (European Council, Council, European Parliament, Commission, European Court of Justice, and European Central Bank), the position of the Member States of the Union, and various other institutional matters. Part four explores the various decision-making processes, addressing not only the legislative and executive decision-making, but also the budget, CFSP, and external action. The fifth part looks at the legal instruments and the position of EU law in the EU and national legal orders, with an attention to the key principles of primary and direct effect, and the role of fundamental rights and the Charter of Fundamental Rights. The final part sets out the complete and coherent system of judicial protection in the European Union, offering an overview of the various courses of action before the EU courts and in the national legal orders to enforce EU law or to obtain judicial protection.
Download or read book The Effects of Greater Economic Integration Within the European Community on the United States written by United States International Trade Commission and published by . This book was released on 1991 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Value Added Tax written by Alan Schenk and published by BRILL. This book was released on 2022-10-17 with total page 752 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Report of the Workshop on the Harmonization of Marine Fisheries Policy Within Coastal Countries of the Southern African Development Community Zanzibar United Republic of Tanzania 24 27 July 2001 written by Food and Agriculture Organization of the United Nations and published by Food & Agriculture Org.. This book was released on 2002 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Workshop discussed the main working documents presented by the project steering committee: a comparative analysis of the fisheries legal frameworks of SADC coastal countries; an analysis of international and intraregional trade of fisheries products; and a synthesis of the national reports prepared by the countries.
