Download or read book Good Manufacturing Practice GMP Guidelines written by Mindy J. Allport-Settle and published by Pharmalogika. This book was released on 2009-12 with total page 686 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union.

Download or read book Principles Definitions and Model Rules of European Private Law written by Study Group on a European Civil Code and published by sellier. european law publ.. This book was released on 2008 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this volume, the Study Group and the Acquis Group present the first academic Draft of a Common Frame of Reference (DCFR). The Draft is based in part on a revised version of the Principles of European Contract Law (PECL) and contains Principles, Definitions and Model Rules of European Private Law in an interim outline edition. It covers the books on contracts and other juridical acts, obligations and corresponding rights, certain specific contracts, and non-contractual obligations. One purpose of the text is to provide material for a possible "political" Common Frame of Reference (CFR) which was called for by the European Commission's Action Plan on a More Coherent European Contract Law of January 2003.

Download or read book Handbook on European data protection law written by Council of Europe and published by Council of Europe. This book was released on 2018-04-15 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rapid development of information technology has exacerbated the need for robust personal data protection, the right to which is safeguarded by both European Union (EU) and Council of Europe (CoE) instruments. Safeguarding this important right entails new and significant challenges as technological advances expand the frontiers of areas such as surveillance, communication interception and data storage. This handbook is designed to familiarise legal practitioners not specialised in data protection with this emerging area of the law. It provides an overview of the EU’s and the CoE’s applicable legal frameworks. It also explains key case law, summarising major rulings of both the Court of Justice of the European Union and the European Court of Human Rights. In addition, it presents hypothetical scenarios that serve as practical illustrations of the diverse issues encountered in this ever-evolving field.

Download or read book Competition Law of the European Union written by Van Bael & Bellis and published by Kluwer Law International B.V.. This book was released on 2021-03-01 with total page 1618 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new Sixth Edition of a major work by the well-known competition law team at Van Bael & Bellis in Brussels brings the book up to date to take account of the many developments in the case law and relevant legislation that have occurred since the Fifth Edition in 2010. The authors have also taken the opportunity to write a much-extended chapter on private enforcement and a dedicated section on competition law in the pharmaceutical sector. As one would expect, the new edition continues to meet the challenge for businesses and their counsel, providing a thoroughly practical guide to the application of the EU competition rules. The critical commentary cuts through the theoretical underpinnings of EU competition law to expose its actual impact on business. In this comprehensive new edition, the authors examine such notable developments as the following: important rulings concerning the concept of a restriction by object under Article 101; the extensive case law in the field of cartels, including in relation to cartel facilitation and price signalling; important Article 102 rulings concerning pricing and exclusivity, including the Post Danmark and Intel judgments, as well as standard essential patents; the current block exemption and guidelines applicable to vertical agreements, including those applicable to the motor vehicle sector; developments concerning online distribution, including the Pierre Fabre and Coty rulings; the current guidelines and block exemptions in the field of horizontal cooperation, including the treatment of information exchange; the evolution of EU merger control, including court defeats suffered by the Commission and the case law on procedural infringements; the burgeoning case law related to pharmaceuticals, including concerning reverse payment settlements; the current technology transfer guidelines and block exemption; procedural developments, including in relation to the right to privacy, access to file, parental liability, fining methodology, inability to pay and hybrid settlements; the implementation of the Damages Directive and the first interpretative rulings. As a comprehensive, up-to-date and above all practical analysis of the EU competition rules as developed by the Commission and EU Courts, this authoritative new edition of a classic work stands alone. Like its predecessors, it will be of immeasurable value to both business persons and their legal advisers.

Download or read book Private Enforcement of European Competition and State Aid Law written by Ferdinand Wollenschläger and published by Kluwer Law International B.V.. This book was released on 2020-01-09 with total page 439 pages. Available in PDF, EPUB and Kindle. Book excerpt: Private Enforcement of European Competition and State Aid Law Current Challenges and the Way Forward Edited by: Ferdinand Wollenschläger, Wolfgang Wurmnest & Thomas M.J. Möllers The overlapping European Union (EU) regimes of competition law and State aid law both provide mechanisms allowing private plaintiffs to claim compensation for losses or damages. It is thus of significant practical value to provide, as this book does, analysis and guidance on achieving enforcement of such claims, written by renowned authorities in the two fields. The book examines the two areas of law both from an EU perspective and from the perspectives of private enforcement in France, Germany, Italy, the Netherlands, Spain and the United Kingdom. In country reports for these major jurisdictions, as well as in more general and comparative chapters, the authors focus on such issues as the following: impediments to private enforcement; which entity is liable for damages; binding effect of decisions of competition authorities; limitation of actions; collective actions and pooling of claims; enforcement of the standstill obligation (Article 108(3) TFEU); remedies and information deficits; cooperation and coordination between national courts and the European Commission; transposition of the so-called Damages Directive (Directive 2014/104/EU) by the EU Member States; extent to which the strengthening of private enforcement of competition law has a spillover effect on State aid law; and prospects for harmonisation of State aid law. A concluding section identifies enforcement deficits and proposes ways to improve the existing legal framework. As an in-depth assessment of key obstacles and best practices in private enforcement actions, this highly informative and practical volume facilitates choice of the best forum for competition and State aid law cases. Academics and practitioners engaged with this important area of European law will appreciate the authors’ awareness of the economic need and legal particularities which could generate an effective European system of private enforcement of legitimate claims under EU competition and State aid law.

Download or read book An Introductory Guide to EEC Competition Law and Practice written by Valentine Korah and published by . This book was released on 1986 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book A Guide to the European VAT Directives written by Julie Kajus and published by . This book was released on 2017 with total page 1668 pages. Available in PDF, EPUB and Kindle. Book excerpt: Resumen del editor. "Published annually, this two-volume set provides a comprehensive overview of the most essential parts of VAT Directives in Europe. Volume 1 offers a systematic survey of the implications of the legal principles on indirect tax matters and of the VAT rules of the European Union in force, and a discussion of the case law of the Court of Justice of the European Union in indirect tax matters, particularly in VAT. Volume 2 provides an (unofficial) integrated text of Directive 77/388/EEC of 17 May 1977 (the Sixth Directive as amended by subsequent directives, treaties of accession and regulations), as applicable until 1 January 2007. The articles of Council Regulation (EC) No. 1777/2005 of 17 October 2005, laying down implementing measures, are indicated under the articles of the Sixth Directive to which they relate. The latest directive integrated into the text is Directive 2006/98/EC of 20 December 2006. This integrated text is unofficial in nature, since headings and footnotes have been added and, where relevant, the text of other directives inserted. On 28 November 2006, Directive 2006/112/EC on the common system of value added tax (the Recast of the First and Sixth VAT Directives) was adopted, entering into force on 1 January 2007. In order to improve the drafting quality, the text of the Sixth Directive has undergone numerous changes. Although the changes do not affect its substantive content, they do alter the format with the 53 articles of the Sixth Directive divided into 414 new articles, of which article 411 repeals the Sixth Directive as set out in this integrated text "

Download or read book Guide to Foreign and International Legal Citations written by and published by . This book was released on 2006 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Formerly known as the International Citation Manual"--p. xv.

Download or read book The European Marketplace written by James Hogan and published by Springer. This book was released on 1990-11-19 with total page 565 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book An Introductory Guide to EC Competition Law and Practice written by Valentine Korah and published by . This book was released on 1994 with total page 2354 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Principles of European Constitutional Law written by Armin von Bogdandy and published by Bloomsbury Publishing. This book was released on 2009-12-03 with total page 856 pages. Available in PDF, EPUB and Kindle. Book excerpt: For the time being, the political project of basing the European Union on a document entitled 'Constitution' has failed. The second, revised and enlarged edition of this volume retains its title nonetheless. Building on a scholarly rather than black-letter law account, it shows European constitutional law as it looks following the Treaty of Lisbon, with the EU's foundational treaties mandating the exercise of public authority, establishing a hierarchy of norms and legitimising legal acts, providing for citizenship, and granting fundamental rights. In this way the treaties shape the relations between legal orders, between public interest regulation and market economy, and between law and politics. The contributions demonstrate in detail how a constitutional approach furthers understanding of the core issues of EU law, how it offers theoretical and doctrinal insights, and how it adds critical perspective. From Reviews of the First Edition: "...should be mandatory reading for anyone who wants to get a holistic perspective of the academic debate on Europe's constitutional foundations...It is impossible to present the richness of thought contained in the 833 pages of the book in a short review." Common Market Law Review "an enduring scholarly work, which gives an English-speaking audience important, and overdue, access to the long-standing and forever-vigorous traditions of (European) constitutional law... unhesitatingly recommend[ed]." European Law Journal "...real scholarship in the profound sense of the word..." K Lenaerts, Professor of European Law, Leuven

Download or read book Economic Policies and Practices written by United States. Congress. Joint Economic Committee and published by . This book was released on 1963 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Steiner Woods EU Law written by Josephine Steiner and published by Oxford University Press, USA. This book was released on 2012-08-30 with total page 862 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'EU Law' covers both the institutions of the EU and the substantive law they produce. The new constitution is introduced, its aims and the reasons for its negotiation. Pedagogical features have been incorporated into this edition making the text easier to navigate

Download or read book An Introductory Guide to EC Competition Law and Practice written by Valentine Korah and published by . This book was released on 1994 with total page 1002 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Download or read book Handbook of Environmental Impact Assessment Volume 2 written by Judith Petts and published by John Wiley & Sons. This book was released on 2009-04-01 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: Environmental Impact Assessment (EIA) is a significant, anticipatory, environmental management tool. International debate focuses on its enhancement to meet the challenges of sustainable development as well as demands for scientifically robust integrated and participative decision-making. This handbook hopes to improve practices by contributing an international, multidisciplinary, ready-reference source to this debate. Volume I addresses EIA principles, process and methods. Part 1 maps the EIA process and its impact on decision. It positions EIA in the context of sustainable development and relative to other decision tools, including economic valuation. It also positions strategic environmental assessment (SEA) in a similar way. Part 2 addresses the elements of the EIA process and significant impact assessment topics (air, water, ecological, social, risk, landscape and visual) not only in terms of good practice but also methodological evolution. This volume concludes by addressing cumulative impact assessment and SEA methods. Volume II provides a unique consideration for EIA implementation and practice in Europe, Africa, the Far East, South America and North America. It uses a number of project types to provide 'how to do' guidance and addresses practice in policy and plan assessment. This book should be read by legislators, decision-makers, economists, developers, industrial managers and consultants involved in this significant field.

Download or read book Essential EU law in charts written by Christa Tobler and published by . This book was released on 2014 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: