This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators.

On 1 December 2009 the Treaty of Lisbon entered into force. Although often described as primarily technical, it significantly amended the Treaty on the European Union (TEU) and the old EC Treaty (now the Treaty on the Functioning of the European Union, TFEU). The authors' aim in this book is to explore what the Treaty means for social law and social policy at the European level. The first part of the book on the general framework looks - at a time of financial crisis - for new foundations for Europe's Social market economy, questions the balance between fundamental social rights and economic freedoms, analyses the role of the now binding Charter of Fundamental Rights, maps the potential impact of the horizontal clauses on social policy and addresses the possibilities for social partners to enlarge their role in labour law and industrial relations. The second part, on the social framework of the Treaty, focuses on the development of the Union's competences. In it the authors evaluate the consequences of the new general framework on social competences, analyse the evolution of the principle of subsidiarity and its impact in the new Treaty, look at the coordination of economic policies in the light of fundamental rights, and analyse the adoption in the Treaty of a new architecture for services of general interest.

Social justice and the market economy often seem to be on a collision course. Human dignity and equal treatment are of little commodity value. More and more, however, labour law theorists are insisting that, without more serious attention to human rights in the workplace, the dominance of market-driven economics will continue to engender grave and potentially explosive social problems. This collection of essays -- composed in honour of the leading labour law and social security jurist Ruth Ben-Israel -- offers incisive perspectives on this vital aspect of today's post-industrial society. Featuring the most recent views of a virtual who's who of major labour law authorities, the book includes in-depth analyses of such important aspects of the field as the following: + workplace representation; + safety and health at work; + labour conflicts; + labour courts; + the ILO supervisory system; + right to strike; + employee privacy; + enterprise reorganisation; and + treatment of blue collar vs. white collar workers. All issues are treated from a comparative legal viewpoint, with valuable contributions from Germany, Italy, Belgium, the Netherlands, the United Kingdom, the United States, Israel, and Japan. Ruth Ben-Israel is notable for her commitment -- as teacher, writer, and international advisor - to the continuity and expansion of social justice as the welfare state has increasingly succumbed to the pressure of the corporate-driven global economic model. Her extensive body of work emphasizes collective bargaining, strikes and lockouts, workers' participation, equal employment opportunity (especially for women), and unfair dismissal. Labour Law, Human Rights and Social Justice is a faithful and fitting tribute from her colleagues to her determination and eloquence in pursuing this most worthy of goals.

The Internet brings opportunity and peril for media freedom and freedom of expression. It enables new forms of publication and extends the reach of traditional publishers, but its power increases the potential damage of harmful speech and invites state regulation and censorship as well as manipulation by private and commercial interests. In jurisdictions around the world, courts, lawmakers and regulators grapple with these contradictions and challenges in different ways with different goals in mind. The media law reforms they are adopting or considering contain crucial lessons for those forming their own responses or who seek to understand how technology is driving such rapid change in how information and opinion are distributed or restricted. In this book, many of the world's leading authorities examine the emerging landscape of reform in nations with variable political and legal contexts. They analyse developments particularly through the prisms of defamation and media regulation, but also explore the impact of technology on privacy law and national security. Whether as jurists, lawmakers, legal practitioners or scholars, they are at the front lines of a story of epic change in how and why the Internet is changing the nature and raising the stakes of 21st century communication and expression.

The debate over teaching evolution in the public schools remains one of the most emotionally charged controversies in twentieth-century America. This third edition of Edward J. Larson's highly acclaimed study - which ranges from before the Scopes trial of 1925 to the creationism disputes of the 1980's - offers the first comprehensive account of the educational and legal battles errupting from this persistent belief.

The South African Schools Act 84 of 1996 aims to make high-quality basic education accessible to all South African children irrespective of race and geographic location in the country. Written by significant role-players and members of the judiciary, Pathways to Successful Schooling reflects on the journey of South African schooling over the past 20 years. This book was prompted by the 2016 Schools Act symposium, Schools Act @ 20: Charting the Way Forward, which celebrated the 20th anniversary of the Schools Act. Looking at education since 1996, this book considers practical alternatives for addressing contentious matters. Unique to this work is the inclusion of the first ever analysis of the background to the drafting of the Schools Act. Pathways to Successful Schooling gives perspectives on dreams, expectations and realities. It reflects on what became of the vision of the Education White Paper 1 and the Schools Act. An international dimension is added by the discussion of constitutional changes and values in the context of the United Nations' Sustainable Development Goals. The book also looks at legislating for the realisation of children's rights and offers the view that, although the Act has set the pace, broader efforts will enhance children's rights in South Africa.

One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchical system of rules characterized by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created at both the international and regional level are directly applicable to national legal systems. Also, norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation.

In this project the author uses multilevel regulation as a term to characterize a regulatory space in which the process of rule making, rule enforcement and rule adjudication (the regulatory lifecycle) is dispersed across more than one administrative or territorial level and amongst several different actors, both public and private. The author draws on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is non-hierarchical and they may be independent of each other. The lack of central ordering of the regulatory lifecycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for the notion of legal certainty have attracted limited attention from scholars and the demand for legal certainty in regulatory practice is still a puzzle. The book explores the idea of legal certainty in terms of the perceptions and expectations of regulatees in the context of medical products - specifically, pharmaceuticals and medical devices, which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, the book necessarily explores new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies it in the context of multilevel regulation.

Under articles 149 (education) and 150 (vocational training) of the European Union Treaty, the EU has competence to complement the education systems of Member States. This book not only explores the nature and likely extent of that competence, but investigates other ways in which education law and policy may grow at the European level. Beginning with a detailed analysis of EU law and policy in this area and how it has developed, the author identifies the maximum extent Community education and vocational training competencies may reach under Articles 149 and 150. Although the Community may indeed implement education and vocational training policies with a very wide content, the kind of action it may carry out in these fields is limited by the nature of the competence it has received. However, "Towards an EU Right to Education" goes on to investigate whether Community education and vocational training competencies may have a distinct parallel evolution outside the framework of the two Articles in question. Focusing on the issues of individual educational and training rights under Community law, the author shows that the development of education and vocational training competencies may still occur in the context of European citizenship, free movement and equal treatment. This approach to the issue of education is clearly affirmed by the recent consolidation of a right to education in the Charter of Fundamental Rights of the European Union - a step which strongly implies the transnational application of a national right to education.

In this book various perspectives on fundamental rights in the fields of public and private international law are innovatively covered. Published on the occasion of the 50th anniversary of the T.M.C. Asser Instituut in The Hague, the collection reflects the breadth and scope of the Institute's research activities in the fields of public international law, EU law, private international law and international and European sports law. It does so by shedding more light on topical issues - such as drone warfare, the fight against terrorism, the international trade environment nexus and forced arbitration - that can be related to the theme of fundamental rights, which runs through all these four areas of research. Points of divergence and areas of common ground are uncovered in contributions from both staff members and distinguished external authors, having long-standing academic relations with the Institute. The Editors of this book are all staff members of the T.M.C. Asser Instituut, each of them representing one of the areas of research the Institute covers.

This book is a comprehensive, practice-oriented guide to the evidentiary regime under the 2015 World Anti-Doping Code (WADC) including the functioning of the Athlete Biological Passport. It is the first to show how the interplay between science and law affects the collection and evaluation of evidence in anti-doping, and how paradigm shifts in anti-doping strategies may modify evidentiary assumptions implicit to the WADC regime. Unique in its dealing with the subtleties of anti-doping science and legal implications, the book gives lawyers involved in anti-doping the keys to a better understanding of the science underlying the WADC regime, while providing anti-doping scientists with the first reference material to understand the legal framework in which their activities are embedded. The emphasis of the book is on international doping cases and it relies predominantly on CAS awards published up to Spring 2015. Written by an experienced Swiss lawyer it provides an insight into the Swiss legal system and its importance for the legal practice in doping matters. Marjolaine Viret is an attorney-at-law in Geneva, Switzerland, specialising in sports and health law. She has gained significant experience in sports arbitration as a senior associate in one of Switzerland's leading law firms. She also holds positions within committees in sport, in particular as a member of the UCI Anti-Doping Commission. Ms Viret had her doctorate on anti-doping approved summa cum laude in 2015. She participates as a researcher in a project for a commentary of the 2015 WADC funded by the National Science Foundation and is regularly invited to lecture or speak in various fields of sports law. The book appears in the ASSER International Sports Law Series, under the editorship of Dr. Dave McArdle, Prof. Dr. Ben Van Rompuy and Marco A. van der harst LL.M.

David Saari provides an extended essay on the nature of freedom in contemporary America, its historical roots, and its present-day manifestations. Drawing on the fields of history, law, politics, business, and philosophy, this wide-ranging study examines three facets of freedom--national freedom, freedom from the state, and freedom within the state--as they have developed in American law, politics, and society. Each of these facets is carefully defined and then applied to such contemporary issues as authority, property, equality, justice, and privacy.

Organ transplantation is a much-discussed subject, and the importance of living organ donation is increasing significantly. Yet despite all efforts, too few donor organs are available to help all patients in need. This book analyses whether the national legal regulations are also partly responsible for the organ shortage in the Member States of the European Union. In addition to a detailed analysis of the various national regulations, the main arguments in favour of and against legal restrictions on living organ donation are considered. Furthermore, the European Union's authority is investigated, namely, whether it is entitled to establish statutory provisions for the Member States with respect to a harmonized regulation of living organ donation. Based on the results of the analysis, the author establishes a Best Practice Proposal for living organ donation.

This study is an empirical analysis of how the fluctuating legal environment in the courts surrounding obscenity litigation over a thirty year period is an appropriate vehicle with which to demonstrate the dynamics of widespread group involvement in the judicial process. Joseph F. Kobylka traces how the development of the obscenity law from the 1957 Roth v. United States decision, which established the proscription of obscenity through its libertarian interpretation by the Warren court and its reaffirmation by the 1973 Miller v. California decision, necessitated changes in both the behaviors and strategies of libertarian and conservative groups in the active pursuit of their particular goals.

After a review of the shifts in the Supreme Court's doctrines concerning obscenity, Kobylka identifies the various political interest groups, and examines their motives, goals, and the factors, both internal and external, that determined their responses to Miller. He concludes with a summary of findings confirming that the study's empirical approach yields a comprehensive understanding of the fluidity of group politics. Specific group involvement is documented in the appendices, and bibliographies furnish lists of books, articles, and a table of cases. "The Politics of Obscenity" will be a useful, authoritative volume for advanced courses in the judicial process and group politics, and will also be invaluable to academic libraries, political scientists, and other scholars.

This volume deals with institutions, implementation and innovations in the field of international marine environmental law. It discusses some controversial legal aspects of the marine environment in the context of UNCLOS, as a framework for national, regional and global action in the marine sector. The purpose of this work is to faithfully report scientific expertise, legal insight and policy wisdom presented by the speakers and participants at the Conference. The book identifies major aspects of the current situation and possible future developments in a critical way. Among the key issues covered are implementation and enforcement of environmental conventions; the avoidance, prevention and settlement of disputes; and, liability and compensation for environmental damage. Also included are several articles that discuss the role of the main institutions in this field within the UN system. There is a companion website--andreekirchner.de/imel--specially created to work alongside the texts. A selected bibliography, documents, conventions and links connected to the contents of the book are included to provide an updated and comprehensive resource for the reader.

This study examines and explains the relationship between social health insurance (SHI) participation and out-of-pocket expenditures (OOP) as well as the mediating role the institutional arrangement of SHI plays in this relationship in China. Embracing a new institutionalist approach, it develops two analytical perspectives: determination, which identifies the mechanisms of social health insurance, and strategic interaction, which explores the interaction among social health insurance agencies, healthcare providers, patients, and institutions. It reveals the poor performance of social health insurance in decreasing out-of-pocket health expenditures caused by a trade-off between the reimbursement, behavior management, and purchasing mechanisms of social health insurance programs. Further, it finds that the inequitable allocation of healthcare resources and patients' concerns regarding the benefits offset the strategies used by social health insurance agencies to manage care-seeking behavior. It also discovers that the complex interactions between insurance agencies, doctors, patients and a larger disenabling institutional surrounding restricts the purchasing efficiency of social health insurance. This book is characterized by its unique synthesis of the role of the institutional arrangement of social health insurance in China, the interaction between the stakeholders in health sectors, and of the relationship between healthcare institutions, actors, and policy outcomes. Providing a comprehensive overview, it enables scholars and graduate students to understand the ongoing process of social health insurance reform as well as the dynamics of health cost inflation in China. It also benefits policymakers by recommending a single-payer model based on an evidence-based investigation.

This book examines how intellectual property rights (IPR) affect the daily lives of individuals worldwide and how that may in turn impact the health and wealth of nations. While the protection of the intellectual endeavours of authors and inventors is vital for a fair and just society it is important that the IPR regime remains flexible enough to encourage creativity, innovation and the free flow of information and technology that are critical to the well being of billions of people, especially in the developing world. This work examines the implications of the IPR regime for basic human security. It examines the relationship between IPR regime and fundamental human rights, such as the right to education, health and food, and the broader right to development. This book will be of interest to IP scholars, international relations specialists and international security analysts, in particular those interested in non-traditional security issues. It may also serve as resource book for the international business community on developmental and human rights aspects of IP.

A comprehensive reference work intended for the business community, sports clubs, sponsors, international sports associations, sports administrators, agents, advertising agencies, sponsorship and marketing directors, licensing and mechandising executives and legal counsels. It covers in detail: sponsorship relationship (contract law); formalities of contract; tax aspects; exclusive arrangements; territorial restrictions; royalties; merchandising; licensing; copyright; trademark policing; advertising; television; video; intellectual property; distribution; insurance; competition law; franchising; packaging; arbitration; litigation; and broadcasting. It covers 26 European countries as well as EC aspects.

"Clubhouse Lawyer" offers an intriguing look at legal cases encountered in the world of sports and the principles behind them. Author and attorney Frederick Day offers an insider's perspective as essential to sports fans and athletes as the batting cage or the putting green. "Clubhouse Lawyer" belongs in every fan's library, if not in the dugout itself.

EU Anti-Discrimination Law provides a detailed and critical analysis of the corpus of European Union law prohibiting discrimination on the grounds of sex, racial or ethnic origin, religion or belief, disability, age, and sexual orientation. It takes into account the changes brought about by the Treaty of Lisbon and contains a thorough examination of the relevant case law of the Court of Justice of the EU. The book examines the background to the legislation and explains the essential characteristics and doctrines of EU law and their relevancy to the topic of anti-discrimination. It also analyses the increasingly significant general principles of EU law, the Charter of Fundamental Rights, and the relevant law flowing from the European Convention on Human Rights. The key concepts contained in anti-discrimination law are subjected to close scrutiny. The substantive provisions of the law on equal pay and the workplace and non-workplace provisions of the governing Directives are similarly examined, as are the numerous exceptions permitted to them. The complex rules governing the rights of pregnant women and those who have recently given birth are dealt with comprehensively and in a separate chapter. Equality in social security schemes is also discussed. The book concludes with an assessment of the practical utility of the existing law and the current proposals for its reform.

A major step towards the comprehensive protection of the Antarctic environment is the adoption of the Protocol on Environmental Protection to the Antarctic Treaty in 1991. The Protocol entered into force in January 1998 and provides a comprehensive system of obligations and prohibitions addressing most types of activities in the region south of 60 degrees south latitude. However, because of the absence of undisputed sovereignty in Antarctica, the legal protection of the Antarctic environment depends on the collective efforts of the Contracting Parties to the Protocol. Have the Contracting Parties adequately incorporated the key provisions of the Protocol into their domestic legal systems? Will the complex of domestic legal systems of the Contracting Parties adequately ensure a 'comprehensive protection' of the 'natural reserve' of Antarctica, as specified by Article 2 of the Protocol? These questions are the subject of this book.

This book explores the disruptive changes in the media ecosystem caused by convergence and digitization, and analyses innovation processes in content production, distribution and commercialisation. It has been edited by Professors Miguel Tunez-Lopez (Universidade de Santiago de Compostela, Spain), Valentin-Alejandro Martinez-Fernandez (Universidade da Coruna, Spain), Xose Lopez-Garcia (Universidade de Santiago de Compostela, Spain), Xose Ruas-Araujo (Universidade de Vigo, Spain) and Francisco Campos-Freire (Universidade de Santiago de Compostela, Spain). The book includes contributions from European and American experts, who offer their views on the audiovisual sector, journalism and cyberjournalism, corporate and institutional communication, and education. It particularly highlights the role of new technologies, the Internet and social media, including the ethics and legal dimensions. With 30 contributions, grouped into diverse chapters, on information preferences and uses in journalism, as well as public audiovisual policies in the European Union, related to governance, funding, accountability, innovation, quality and public service, it provides a reliable media resource and presents lines of future development.

The nature and purpose of legal education has become a topic of intense debate in recent years. This timely book calls for a critical re-evaluation of university legal education, with the particular aim of strengthening its academic nature. The contributors emphasise lecturers' responsibility to challenge the assumptions students have about law, and the importance of putting law in a theoretical and social context that allows for critical reflection and sceptical detachment. In addition, the book reports upon teaching experiences and innovations, offering tools for teachers to strengthen the academic nature of legal education, and concludes with concrete proposals for change. Students and scholars engaged in the debate regarding the re-evaluation of academic legal education will find this book invaluable to their work. It will also be of interest to practitioners, such as educational experts and administrators looking to understand the role of law schools in creating responsible citizens. Contributors include: T. Bleeker, A. Boening, L. Corrias, U. de Vries, M. Del Mar, L. Francot, S. Germain, T. Hutchinson, B. Oomen, C. Schwoebel-Patel, B. Sokhi-Bulley, G. Uygur, B. van Klink, W. van Rossum