The 2022 edition of the Rules and Guidance for Pharmaceutical Distributors, the 'Green Guide', is the essential reference for all distributors, brokers of human medicines, importers and distributors of active substances in the UK.It provides you with the single authoritative source of European good distribution practices and UK guidance, information and UK legislation on these activities.The new 5th edition has been updated to incorporate changes made after the UK's exit from the European Union on the 31st January 2020.It also incorporates new guidance on pharmacovigilance for wholesalers, the naming of sites on a licence, self-inspection, and the responsible person for import.It brings together EU guidance on good distribution practice and the MHRA's expectations for compliance. There is also a new flowchart for the registration of handling active substances

New York City has the largest medical examiner's office in the United States, and the Brooklyn division is the busiest of the five boroughs. Charles A. Catanese received his Forensic Pathology fellowship training in New York, and then worked full time as a Medical Examiner in the Brooklyn office for more than 10 years. He has personally performed more than 4000 autopsies, including over 400 homicides. Dr. Catanese has worked through several disasters, including TWA Flight 800, AA Flight 587, and more than nine months on the World Trade Center fatalities. He is currently the Chief Medical Examiner of Orange County, New York. Drawing on his wealth of knowledge and experience in solving some of the most difficult cases a forensic examiner could encounter, he assembles hundreds of images from his own work experience to present the Color Atlas of Forensic Medicine and Pathology. Featuring twice the number of images as any other forensic pathology atlas, the book is filled with high-resolution photos that demonstrate postmortem changes of the human body and the different types of patterns produced in deaths caused by: Natural causes Diagnostic or therapeutic procedures Substance abuse Poisoning Child abuse Firearms Blunt instruments Sharp instruments Burns Asphyxia This easy-to-read atlas, created for medical and non-medical personnel, covers basic and advanced forensic concepts that relate to all manners of deaths. The carefully worded, unambiguous text describing each photo and the side-by-side comparisons of similar, yet different, pathologies make this remarkable atlas a powerful teaching tool for all those who must confront and solve the mystery of human demise. A fully searchable DVD version is also available.

This book presents a comprehensive analysis of the alterations and problems caused by new technologies in all fields of the global digital economy. The impact of artificial intelligence (AI) not only on law but also on economics is examined. In the first part, the economics of AI are explored, including topics such as e-globalization and digital economy, corporate governance, risk management, and risk development, followed by a quantitative econometric analysis which utilizes regressions stipulating the scale of the impact. In the second part, the author presents the law of AI, covering topics such as the law of electronic technology, legal issues, AI and intellectual property rights, and legalizing AI. Case studies from different countries are presented, as well as a specific analysis of international law and common law. This book is a must-read for scholars and students of law, economics, and business, as well as policy-makers and practitioners, interested in a better understanding of legal and economic aspects and issues of AI and how to deal with them.

Title IX, a landmark federal statute enacted in 1972 to prohibit sex discrimination in education, has worked its way into American culture as few other laws have. It is an iconic law, the subject of web blogs and T-shirt slogans, and is widely credited with opening the doors to the massive numbers of girls and women now participating in competitive sports. Yet few people fully understand the law's requirements, or the extent to which it has succeeded in challenging the gender norms that have circumscribed women's opportunities as athletes and their place in society more generally.

In this first legal analysis of Title IX, Deborah L. Brake assesses the statute's successes and failures. While the statute has created tremendous gains for female athletes, not only raising the visibility and cultural acceptance of women in sports, but also creating social bonds for women, positive body images, and leadership roles, the disparities in funding between men's and women's sports have remained remarkably resilient. At the same time, female athletes continue to receive less prestige and support than their male counterparts, which in turn filters into the arena of professional sports. Brake provides a richer understanding and appreciation of what Title IX has accomplished, while taking a critical look at the places where the law has fallen short. A unique contribution to the literature on Title IX, Getting in the Game fully explores the theory, policy choices, successes, and limitations of this historic law.

Patient abuse and neglect is a daily occurrence in our nation's medical and psychiatric hospitals, nursing homes, group homes, and other care facilities. But it is not just in institutional settings where at-risk adults are vulnerable. Crimes of abuse also occur in private homes, beyond the sight of regulators, medical professionals, and even family members.

Using real-world examples from Joseph Bostwick's extensive career leading investigations into cases of patient abuse, "The Patient Abuse and Neglect of Our Vulnerable Adults" provides law enforcement officers, investigators, legal staff, government regulatory agencies, and care providers with the critical information they need to effectively conduct criminal and administrative investigations into allegations of patient mistreatment and neglect. It also provides families and friends with information and resources for identifying and preventing the abuse and neglect of loved ones.

Today, we tend to our vulnerable adults who served our country during World War II, the generation that literally saved the world. Tomorrow, another wave of vulnerable adults awaits our care and protection. The battle against patient abuse and neglect is never-ending, and well-intentioned support and informed diligence is crucial, today and always.

With California's passage of the Save Our State Initiative in 1994, fear of aliens has once again appeared in U.S. legislative history. Since 1790, congressional legislation on federal immigration and naturalization policy has been harsh on Asian immigrants, although less so since 1965. This documentary history covers all major immigration laws passed by Congress since 1790. The volume opens with an overview of the basis on which Congress has restricted Asian immigration. It then includes discussions of particular immigration legislation, showing the significance to Asian Americans and the documents themselves.

With California's passage of the Save Our State Initiative in November 1994, fear of aliens has once again appeared in U.S. legislative history. Since 1790, congressional legislation establishing federal immigration and naturalization policy has been particularly harsh on Asian immigrants. Although Congress has been less hostile to Asian immigration since 1965, there was a renewed effort to limit immigration from Asia as recently as 1989, and the restrictive national mood will undoubtedly find its way into the 1996 elections. Showing the impact of immigration laws on Asian immigrants, this documentary history covers all major immigration laws passed by Congress since 1790.

The volume's opening chapter points to three major theses--that initially Congress restricted and excluded Asian immigration on the basis of its traditional policy of denying citizenship to nonwhite people, that Congress denied Asians entry to the U.S. on the grounds that their culture made them incompatible with Americans, and that Congress passed laws treating each of the Asian ethnic groups as a racialized ethnic group. The volume then includes discussions of particular immigration legislation, showing the significance to Asian Americans and the documents themselves.

Dr. Scott W. Atlas examines the status of US health care under the Affordable Care Act and presents key reforms to meet the nation's significant health care challenges. Updated for 2020, the revised edition includes the facts about single-payer systems and the implications of Medicare for All proposals. Atlas's six-point incentive-based plan instills market-based competition, empowers consumers, and reduces government authority over health care. These reforms lower costs, stimulate innovation, and broaden access to quality care.

Founded in 1981, the Cardozo Arts & Entertainment Law Journal is one of the first student-edited entertainment law journals in the United States. Over the course of the years, it has grown to be one of the most widely-subscribed journals in the field. To celebrate the 20th anniversary of the Journal, this volume collects some of the most widely-cited articles published in the past 20 years, as well as distinguished intellectual property lectures sponsored by the Benjamin N. Cardozo School of Law, Yeshiva University. Contributors to this volume include leading commentators in the field of intellectual property, art, and communications law, as well as eminent jurists and former government officials from the U.S. Copyright Office and the U.S. Patent and Trademark Office.

This book outlines the legal powers of a major Western nation - Australia - to collect and use location information. Mobile service and social media service providers now have the ability to track, record and store more precise location information. Unlike 4G, 5G mobile communications require that cell towers and antennas be in much closer proximity; as a result, the location data can reveal more personal and sensitive information about individual citizens. Despite this aspect, service providers are required to disclose the data to the authorities, without the need for a judicial warrant. This book was written from the perspective of big location data software analytics, a capability that makes it possible to combine various location data points to create a profile on a given individual's movements, habits, and political, religious and ideological orientation. In this regard, privacy is poorly protected. The rationale used to justify the powers was enforcing serious crimes - terrorism offences. Location data can now be retained for at least two years and be collected to investigate even minor offences. This can be done without the person being reasonably suspected of a criminal offence - when the individual is simply determined to be a person of interest. This poses legal risks to vulnerable communities. And yet, such investigative techniques are deemed lawful and reasonable. At a time when national security is so broadly defined to include economic issues, which in turn overlap with climate change and environmental protection, these legal powers should be reassessed. The book clarifies the complex rules that every citizen must know in order to have agency. Further, it calls upon authorities to reflect and to self-regulate, by making the conscious decision to surrender some of their powers to review by the independent judiciary. Without the requirement for a judicial warrant or judicial review, the powers are unfairly broad. The book pursues an interdisciplinary approach to assess the functionality of mobile telecommunications in direct relation to law enforcement powers and existing judicial precedents. Further, it offers a unifying techno-legal perspective on a complex issue touching on modern privacy law and communications technologies.

This book offers a new perspective on advance directives through a combined legal, ethical and philosophical inquiry. In addition to making a significant and novel theoretical contribution to the field, the book has an interdisciplinary and international appeal. The book will help academics, healthcare professionals, legal practitioners and the educated reader to understand the challenges of creating and implementing advance directives, anticipate clinical realities, and preparing advance directives that reflect a higher degree of assurance in terms of implementation.

This book provides a comprehensive overview on the long-term care systems in 12 EU member states and Norway. Focusing on the legal background and its main principles, it includes a comparative analysis which highlights the principal dissimilarities between European long term care benefits, but at the same time also a variety of features in common. It also discusses the increasingly transnational dimension of long-term as a result of migrants returning to their country of origin in old age, and the still-unsolved legal problem of entitlement to long-term care benefits in another EU-member state.

This book provides a comprehensive overview of the development of educational policies and legislation in China, particularly following the introduction of Reform and Opening Up in 1978. The scope of this book: (1) provides the theoretical basis and framework of educational policies; (2) explains key educational laws and legislation; and (3) introduces readers to policies for educational internationalization, private education, lifelong learning and teacher education. The book is intended for researchers, teachers and graduate students in the field of comparative education, educational policy and legislation, educational management. Readers will find essential information on the most important educational laws and legislation, as well as the recent characteristics of and trends in educational policies in China.

This collection is the multifaceted result of an effort to learn from those who have been educated in an American law school and who then returned to their home countries to apply the lessons of that experience in nations experiencing social, economic, governmental, and legal transition. Written by an international group of scholars and practitioners, this work provides a unique insight into the ways in which legal education impacts the legal system in the recipient's home country, addressing such topics as efforts to influence the current style of legal education in a country and the resistance faced from entrenched senior faculty and the use of U.S. legal education methods in government and private legal practice. This book will be of significant interest not only to legal educators in the United States and internationally, and to administrators of legal education policy and reform, but also to scholars seeking a more in-depth understanding of the connections between legal education and socio-political change.

This book offers an exhaustive analysis of extraterritorial employment standards. Part I addresses the U.S. role in the enforcement of internationally recognized worker rights in the world community. Worker rights include the right of association; the right to organize and bargain collectively; a prohibition on the use of any form of forced or compulsory labor; a minimum age for the employment of children; acceptable conditions of work with respect to minimum wages, hours of work, and occupational safety and health; and the right to work in an environment free from discrimination. By using economic coercion in the form of preferential trade benefits, investment incentives, and trade sanctions, the United States attempts to encourage foreign governments and employers, both local and transnational, to abandon exploitative working conditions for employment standards recognized by the world community. Part II is an exhaustive review of employment standards for U.S. citizens employed abroad, including equal employment opportunity standards. It also addresses extraterritorial wage and hour regulation and federal statutes establishing worker compensation standards to persons employed at military installations or in areas where the risk of war hazards are prevalent. Part III is a discussion of the policy concerns and implications of extraterritorial employment standards. These standards impact domestic producers, domestic workers and their representative organizations, consumers, exporters and importers, as well as multinational enterprises and their employees. This book is indispensable for managers, legal counsel for employers and employees, and policy makers and labor leaders in any industry having contact with the global economy.

In this analysis of federal court cases relying upon the landmark Roe v. Wade decision, the author finds that the pro-life movement in the United States has suffered repeated losses in abortion litigation. Additionally, her research indicates that, despite claims to the contrary, the pro-life movement is a loose collection of underfunded and understaffed public interest organizations. The pro-choice forces are vastly more powerful in abortion litigation, have superior organization and financing, and include not only public interest groups but also private interests such as clinics and professional medical organizations. Divided into three parts, the study begins with a public law analysis of the progeny of Roe cases, examining those variables which appear to impact court decisions. Next the work examines political factors and litigation resources as variables in explaining court decisions. And finally, the work offers a descriptive analysis of abortion litigants which divides the groups into major categories and evaluates them in terms of their resources, longevity, and other such factors. This book will be of interest to those seriously interested in the political and legal ramifications of the abortion controversy.

This book discusses feature films that enrich our understanding of doctor-patient dilemmas. The book comprises general clinical ethics themes and principles and is written in accessible language. Each theme is discussed and illuminated in chapters devoted to a particular film. Chapters start with a discussion of the film itself, which shares details behind the making of the film; box-office and critical reception; casting; and other facts about production. The chapter then situates the film in a history of medicine and medical sociology context before it delves into the clinical ethics issues in the film, and how to use it as a teaching aid for clinical ethics. Readers will understand how each film in this collection served to bring particular clinical ethics issues to the public's attention or reflected medico-legal issues that were part of the public discourse. The book is a perfect instructor's guide for anyone teaching bioethics, healthcare ethics, medical sociology, medical history, healthcare systems, narrative medicine, or nursing ethics.

Participatory democracy has become a buzzword in current discussions about how to democratize the EU. European institutions associate it with civil society involvement in European governance and claim that it might reduce its so-called democratic deficit. The Treaty of Lisbon formalizes this promise by enacting a new Article 11 TEU specifically dedicated to participatory democracy as a founding principle of the EU legal order. This participatory turn has already attracted much scholarly attention. However, two fundamental paradoxes have been overlooked.Whereas participatory democracy was traditionally meant to further the maximum participation of citizens in political life, the EU supports a modern version of the participatory ideal where citizens are represented by a selfdesignated elite of civil society experts. This book takes a critical stance on that technocratic form of government. At the same time, it examines whether there are realistic ways for a bureaucratic organization like the EU to involve a truly civil society of active citizens in governance.Participatory democracy was also intended to overcome the social inequalities of market capitalism. Yet, the EU came into existence as a European economic community embracing free and undistorted competition. This book claims that European civil society may only flourish if social Europe acts as a counterweight to economic Europe. So it analyses whether the EU has developed a social dimension strong enough to protect civil society from the colonizing forces of European economic integration.The author is currently working as an attorney at Van Olmen & Wynant, a Brussels-based law firm with a niche expertise in social and employment law. He also holds a PhD in law from the University of Leicester, awarded for the doctoral thesis upon which this book is based.

View the Table of Contents. Read Chapter 1.

aJackson is at his best when exposing the connections of leading racialists with former Nazi party members and Holocaust-denial groups.a
--"Journal of American Ethnic History"

aA well-researched and well-argued book....Jackson underscored the nexus of asciencea and arace, a probes the ademarcation between science and politics, a and questions the very meaning of aobjectivea scientific inquiry.a
--"Historian"

aScience for Segregation adds considerably to our understanding of racist ideologies and their persistance in the post-war era. The author has done an admirable job of covering a forgotten chapter in the struggle over segregation and shedding light on how scientific research can become highly politicized.a
--"Journal of American History"

"This book asks if science can be divorced from politics. . . . Recommended."
--"Choice"

aA fascinating and comprehensive look at a largely neglected aspect of American history--the role of science and scientists in supporting and sustaining white racist thought and institutions during the battle over de-segregation. And like most good social history, it does not require much strain to draw the relevance to today's debates about the salience of biological taxonomies of race.a
--Troy Duster, author of "Backdoor to Eugenics"

aA very important book that explores the fuzzy zone between science and pseudo-science, exposing the political action of right-wing scientists in the 1950s and 1960s who argued for school segregation on ostensibly scientific grounds. The role of science as an authority in society has never been more evident than in the work and rhetoric of these zealouslyracist scholars. This well-researched book is a must-read for anyone interested in modern debates over the study of human diversity or the role of science in contemporary society.a
--Jonathan Marks, author of "What It Means to Be 98% Chimpanzee: Apes, People, and Their Genes"

aA deeply-researched, fascinating, and judicious assessment of the ascientifica arguments that were marshaled against the Supreme Courtas landmark school desegregation decision. Jackson has made a contribution that will endure.a
--Raymond Wolters, author of "Du Bois and His Rivals"

aJacksonas thorough research and a nuanced understanding of the complexities of race and law provide a disturbing cadence to the ongoing debate on race in America.a
--"Multicultural Review"

In this fascinating examination of the intriguing but understudied period following the landmark "Brown v. Board of Education" decision, John Jackson examines the scientific case aimed at dismantling the legislation.

Offering a trenchant assessment of the so-called scientific evidence, Jackson focuses on the 1959 formation of the International Society for the Advancement of Ethnology and Eugenics (IAAEE), whose expressed function was to objectively investigate racial differences and publicize their findings. Notable figures included Carleton Putnam, Wesley Critz George, and Carleton Coon. In an attempt to link race, eugenics and intelligence, they launched legal challenges to the Brown ruling, each chronicled here, that went to trial but ultimately failed.

The history Jackson presents speaks volumes about the legacy of racism, as we can see similar arguments alive and well today in such books as "The Bell Curve" and in otherdebates on race, science, and intelligence. With meticulous research and a nuanced understanding of the complexities of race and law, Jackson tells a disturbing tale about race in America.

The piecemeal developments in product liability reform in Europe have their origins in the tragic association of phocomelia in children with thalidomide in 1962. In many ways these events have continued to generate pressure for reform of product liability, especially for the victims of drug-induced injury. This monograph attempts to address the major problems that typify claims for drug-induced injury, as well as highlighting the complex interrelationship between liability exposure and drug regulation. While medicinal products are subject to strict liability under the product liability directive, the claimant may have considerable difficulty in establishing that the relevant product is defective and that it caused the damage. It may also be necessary to overcome the development risk defence where this is pleaded. The monograph addresses these problems on a comparative jurisprudential basis, and seeks to determine whether medicinal products should be treated as a special case in the field of product liability. It examines the role of epidemiological evidence in assessing causation in product liability cases concerning medicinal products in the light of recent developments in the UK Supreme Court, the United States, Canada and France. In particular, it addresses the difficulties in reconciling the standards of proof in law and science, including the theory that causation can be proved on the balance of probabilities by reference to the doubling of risk of injury. An important case study compares and contrasts the approaches of the UK and the US to the measles, mumps, rubella Litigation. The book also examines the question as to whether compliance with regulatory standards should protect pharmaceutical manufacturers from product liability suits. It seeks to support a via media whereby the victims of drug induced injury can receive justice, while at the same time encouraging drug safety and innovation in drug development.

This book delves into the legal traditions that relegated women to an inferior social and legal status worldwide. Winnie Hazou probes the nature of law, changes in legislation, and the trend of modern law toward a social engineering that effects gender equality. Hazou analyzes changes in major areas of women's lives, such as family, employment, and the acquisition of social power. She presents a global perspective of women's status and discusses international law aimed at eliminating the exploitation and abuse of women. The book highlights five countries, exploring the cultural basis for and social attitudes toward the position of women in each country. Students and scholars of women's studies will find this book a valuable resource.

The book concludes that both national and international law are slowly evolving into an effective tool for the elimination of discrimination against women. In spite of residual traditions, and beliefs across all cultures concerning gender roles, there is great institutional support in governments as well as the United Nations to elevate the status of women. This book combines the sociology of women and the sociology of law to give a global perspective on not only the current position of women but the changes that are occurring in their lives.

The relationships between knowledge, technologies, and legal processes are central to the constitution of contemporary societies. As such, they have come to provide the focus for a range of academic projects, across interdisciplinary legal studies and the social sciences. The domains of medical law and ethics, intellectual property law, environmental law and criminal law are just some of those within which the pervasive place and 'impact' of technoscience is immediately apparent. At the same time, social scientists investigating the making of technology and expertise - in particular, scholars working within the tradition of science and technology studies - frequently interrogate how regulation and legal processes, and the making of knowledge and technologies, are intermingled in complex ways that come to shape and define each other. This book charts the important interface between studies of law, science and society, as explored from the perspectives of socio-legal studies and the increasingly influential field of science and technology studies. It brings together scholars from both areas to interrogate the joint roles of law and science in the construction and stabilization of socio-technical networks, objects, and standards, as well as their place in the production of contemporary social realities and subjectivities.