The Generic Challenge

Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition)

by Martin A. Voet

09/07/2016

This Fifth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.

Knowledge Management in Police Oversight

Law Enforcement Integrity and Accountability

by Petter Gottschalk

09/24/2009

Police oversight agencies are citizens' watchdog organizations designed to ensure that the police are operating with integrity and accountability. Integrity is defined as the quality of being honest and morally upright. Accountability refers to situations in which someone is required or expected to justify actions or decisions. Based on integrity and accountability challenges in police forces all over the world, this book discusses the roles and methods of police oversight agencies. Knowledge management in police oversight is presented by identifying knowledge categories and knowledge management systems. A model for police oversight performance is developed in the book, and the model is applied to an oversight agency as a case study. By the same author: White-Collar Crime: Detection...

Dying To Know.Info

The Comprehensive Guide to Kicking the Bucket including Legal Forms, Estate Planning, Wills, Funeral Arrangements, Death Certificates, Obituaries, Life Insurance, and Everything Else to Prepare Before You Go

by Julian J. Blum

02/24/2014

Dying To Know.Info details an invaluable step-by-step process that will provide your loved ones peace of mind with the legal forms and other information they will need in order to deal with your affairs in the event of your passing. This book presents a fun, humorous, streamlined process to help with the completion of the documents quickly and easily. Everyone will pass on someday, so to a degree everyone needs this book. It contains the forms needed to appoint your executor, the person who gives your beneficiaries the news about who gets your favorite fishing rod or sewing machine. The provided living will expresses whether you want to be kept on life support, or be allowed to meet your maker when your doctor says you are ready to go. It explains how you can cut funeral costs, avoid ...

by Rosemary Passantino (editor)

03/17/2005

This anthology features accessible, enjoyable, thought-provoking essays on timely legal issues by prominent journalists and scholars. Selected from well-known magazines like Atlantic Monthly, Harvard Business Review, The New Yorker, Slate, and Vanity Fair, each essay explores an important question currently being debated in our counts. Should government intervene in the business of a free market? Should people of the same sex be allowed to marry? Should religious icons be displayed in government buildings? Is a college student who mixes music on his laptop a thief? Any reader who would like to gain insight into the workings of the legal system while taking pleasure in excellent writing will enjoy this valuable collection. Including: Vikram Amar on What's Wrong with the Modern Jury Al...

Beyond the Bodyguard

Proven Tactics and Dynamic Strategies for Protective Practices Success

by Gavriel Schneider

05/20/2009

This book is an advanced, well-rounded and in-depth view about what it takes to be the best in the international arena, in a world where change is the only constant. It is endorsed by a wide range of industry experts. This well-researched book will take you to higher levels, enabling you to be among the best in the demanding world of the truly professional bodyguard, by giving you the tools to develop and measure yourself. Who would benefit from this unique and powerful book? 1. Everyone who is in or wants to be involved in the close protection industry 2. Everyone in the security industry worldwide including: - Police, military, and related agencies - Anti-terror and counter-terrorist units - Current Close Protection or bodyguarding organizations - Private security organiz...

Hidden Treuhand

How Corporations and Individuals Hide Assets and Money

by Shelley A. Stark

07/24/2009

What part is Hidden Treuhand playing in the ensuing global financial crisis? The Hidden Treuhand is the single most powerful business tool in the world of globalization today. It is the missing key, reshaping the world’s financial system though few have ever heard of it. With a Hidden Treuhand you can anonymously exercise complete economic rights in all commercial markets worldwide hiding assets and money from stockholders and taxation alike. Many are unaware that U.S. corporations are using Hidden Treuhand to hide the scope of their economic activities – for example - Halliburton. From banks to bailouts, to shareholder value and pension funds – wealth is disappearing. How is it possible to hide stockholder wealth or economic activities worldwide? Hidden Treuhand is a trade...

by Kenneth K. Mwenda

04/08/2003

The book examines principles of arbitration law as they apply to many common law and civil law jurisdictions. In many countries, the use of alternative dispute resolution to resolve matters in areas relating to, say, foreign direct investment and industrial unrest has been heralded by many as a cost-effective way of settling disputes. Chapters in the book cover, among other things: the efficacy of the legal framework for arbitration in Zambia under the Arbitration Act 1933; the efficacy of the legal framework for arbitration under Zambia's Arbitration Act 2000; aspects of international law applicable to the legal framework for arbitration; and efforts to develop international and regional frameworks for arbitration.Other books by this author include: Banking Supervision and Systemac Bank R...

Implicity of Electronic Contract Formation

With Reference to Email and Website

by Taimur Inayat Malik

12/19/2011

This research is conducted with an intention to have an overview of the contracts made online, what possible difficulties can arise within such commercial transactions and to assist readers upon the legal ambiance which environs it.

Prisons in the Neoliberal Era

Class and Symbolic Dimensions

by Dimitris Koros

04/04/2011

The aim of this paper is to explore prison's class and symbolic dimensions in the Neoliberal Era. Neoliberalism was approached as the empowerment of the market which leads to the dismantlement of the social welfare state and to the strengthening of the penal state for the marginalised populations. Also, it was analysed as the 'conduct of conduct' in the Foucauldian sense, as it was argued that prison is a tool of government, functioning for the management of the marginalised populations. An effort was undertaken to discuss the differences of the US, the 'carceral example', with the European Union countries. The class and symbolic dimensions of punishment were first approached from a historical and a theoretical perspective respectively, before attempting to discuss neoliberalism, aiming to...

The Applicable Law to International Commercial Contracts and the Status of Lex Mercatoria

With a Special Emphasis on Choice of Law Rules in the European Community

by Mert Elcin

09/13/2010

International commercial contracts in the context of increasing globalization of the national markets have posed some of the most difficult questions of the legal theory as developed since the emergence of nation states; those are, whether it is possible or desirable to allow international commercial contracts to be governed by the law merchant or, in its medieval name, lex mercatoria, a body of rules which has not been derived from the will of sovereign states, but mainly from transnational trade usages and practices, and to what extent those rules should govern transnational transactions. The traditional approach of legal positivism to the questions maintains that law governing contracts containing a foreign element should be a national law which will be determined according to choice of...

by Lawrence J. Appleman

09/19/2008

The Internet was designed for effective movement of data -accurate and complete- from any point to any other point. The communication protocols, technological foundation, and original governance of the Internet all worked toward this goal. In contrast, legal constraints on transmission of information often have the obverse objectives of limiting, controlling, or preventing this movement of content. This dissertation proposes that the fundamental architecture of the Internet must change in order to allow effective regulation and legal control of content on the Internet.

Sharia Law and the Arab Oil Bust

PetroCurse or Cost of Being Muslim?

by Glenn L Roberts

01/22/2007

The delayed development of the Islamic world, in defiance of the formulaic approaches long favored by economists, suggests that the traditional Sharia and Islamic values and principles are at least partially responsible for the region’s persistent backwardness. By analyzing the impact of the legal regime of the Sharia on Saudi Arabia during the Arab Oil Bust of the 1980s, this thesis concludes that Islamic social values and the Sharia’s de facto role as an uncodified pre-emptive Arab common law implemented with high regard to precedent by ulama with extraordinary power of judicial review had the effect of accentuating the effects of the Oil Bust, making the theory of the Petrocurse a subset of a larger Cost of Being Muslim. On the other hand, the author concludes that not only is th...

Legal Aspects of Privatisation

A Comparative Study of European Implementations

by Bulent Seven

02/12/2003

The main aims of this thesis are as follows:(a) To present a comprehensive analysis of the concept of privatisation its origins and limits, (b) To identify the legal and institutional framework for privatisation in different European countries from a comparative perspective; (c) To define and analyse particularly legal issues which arise during the privatisation transactions: e.g. labour law, competition law etc.; (d) To evaluate which features of the successful legal and organisational framework of privatisation have been successful so as to provide guidelines for those individuals and organisations participating in the privatisation exercises.This work found out that there is no simple, internationally applicable recipe for privatisation; various legal methods and techniques can be used ...

by Sherrie Steiner Aeschliman

12/29/1998

The theory and data of environmental science suggest that growth in rates of population, consumption and environmental degradation, as a result of the activities of industrialized societies, has created an ecological crisis to which modern societies must adapt. However, adaptation is problematic. Max Weber studied adaptive social change during the industrial revolution. The evolution of this new way of life was initially problematic because individuals who established industrialism were socialized under feudalism. In this dissertation, I consider The Protestant Ethic and the Spirit of Capitalism as a theoretical treatise framed by modern human ecology in order to study social change in the context of the ecological crisis of industrialism. The Protestant Ethic is known for descr...

by Seamus Breathnach

07/28/2002

In civilised society the rising "crime rate" is a thing of terror. Clever governments manipulate it, the public messianically fear it, and the social scientists misunderstand it. In the face of such confusion Emile Durkheim reminds us that without a crime rate society is utterly impossible; it cannot constitute itself, maintain its solidarity, or develop morally. In short, we cannot live with or without a crime rate.This dissertation is an exegetical work, and attempts to unpack the Criminology of Emile Durkheim. It is divided into six chapters, five of which are expository, the sixth critical. It begins with a look - in overview - at Durkheim`s philosophy and how it underpins his theories of crime and punishment (chap.1).By their nature theories of crime and punishment (chap.2) presuppose...

by Trevor Hicks

11/28/2003

‘Nervous shock’ cases form an area of law, which illustrates well the operation of judicial policy. It is possible from such cases to trace the changing attitudes of lawyers, doctors and of society in general to psychiatric injury over the last century. These cases also highlight the changing judicial attitudes to the scope of duty of care and to the whole issue of policy decisions.The recognition of nervous shock similarly illustrates the development of medical knowledge in relation to psychiatric injury. The recognition of Post traumatic Stress Syndrome (PTSD) has been a relatively new and controversial phenomenon and this disorder has now been incorporated into the various classifications of mental disorder as a recognisable psychiatric illness.This book examines the development ...

by A. Hunsicker

04/09/2010

Any professional actively engaged in the executive protection field, novice or veteran, whether in a team or as team leader, must train for, and be able to pinpoint, even the most unexpected security concerns. The continuation of The Fine Art of Executive Protection - Handbook for the Executive Protection Officer (2007), Advanced Skills in Executive Protection contains carefully selected and illustrated material for the executive protection and security enforcement professional. All available training and study material, individual case studies, and real scenarios, combined with professional experience, serve as the foundation for this specialist's manual. For the client, as a prospective principal, it provides important details that will assure lifesaving protection. Comprehensive, d...

The Right on Abortion

Comparative Approach Concerning Croatia, Federal Republic of Germany, and US

by Dalida Rittossa

07/19/2008

I. Introduction The actuality of the abortion issue is explained in this chapter. The author expresses his determination to explore philosophical and historical background of this problem in the United States and Germany emphasising the legal development of abortion regulations. The comparative legal method was used as a proper means to illuminate Croatian controversial situation concerning the termination of pregnancy and to contribute in a modest way to probable law reforms. The objective of this thesis is to prove, despite very different substantive rules of abortion regulations in these countries, the similarities behind formal differences which witness about the universality of abortion dilemmas. Bearing this in mind, it is possible to propose suitable legal solutions and to foresee...

Do African Children Have Rights?

A Comparative and Legal Analysis of the United Nations Convention on the Rights of the Child

by Stephen N. Achilihu

05/04/2010

Children are the most politically powerless citizens of all nations. Infants and young children, especially, are the most vulnerable. The United Nations 1989 Convention on the Rights of the Child (CRC) constitutes a landmark in the development of international human rights law and reflects an historic turn in universal thinking about children and their rights. It is almost universally embraced, with more ratifications than any other human rights treaty in history. Africa is one of the continents in the world where the rights of the child are still a mirage; a continent where half of the population is made up of children. But the sad reality for many of these children is that violation of their rights is not seen as a serious problem. These violations, in most cases, have severe conseque...

Incapacitating the Innocent

An Investigation of Legal and Extralegal Factors Associated with the Preadjudicatory Detention of Juveniles

by Patrick R. Webb

09/13/2010

The purpose of this study was to identify the factors associated with the utilization of preadjudicatory detention among juveniles in the United States. Specifically, this study identified: (a) the philosophical basis associated with the utilization of the preadjudicatory detention of juveniles, (b) the legal origins of the preadjudicatory detention of juveniles, (c) a number of theoretical perspectives associated with the use of preadjudicatory detention of juveniles, and (d) whether legal (i.e., prior record, offense, etc.) or extralegal factors (i.e., race, gender, etc.) were associated with the detention of juveniles in the juvenile justice system. The study utilized a quantitative method design in which secondary data were employed. A total of 7,135 juveniles were analyzed from sec...

by Glenn L. Roberts

01/29/2007

Traditional Islamic law has long been regarded as academic, local in nature, and relevant only as a measure of the inadequacy of women’s rights in the family law regimes of a few Islamic states. In opposition, the author argues that the Sharia is both a quasi-regional customary international law capable of competing with prevailing customary international law, and brings its own international agenda of “Islamic human rights” that compete with and seek to displace “Western human rights.” Rather than acknowledging the rights of Muslims qua Muslims internationally, aggressive proponents of an “American customary-law-of-human-rights school” have responded with a new militant doctrine of “instant customary law” to aid the U.S. in its “war on terror,” targeting the Sharia w...

by Bethel G.A. Erastus-Obilo

10/30/2008

Lay participation in the criminal justice process in the form of a jury is a celebrated phenomenon throughout the common law jurisdictions. While not claiming credit for its origin, England, as the latent cradle of the modern jury, disseminated this mode of trial to a great part of the world through colonization. Yet, trial by jury does not enjoy constitutional protection under English law. The system has been under severe criticism, curtailment and considerable pressure in recent times, perhaps far more than in other countries. Critics have demanded reform or outright abolition and supporters have opposed the demands just as vehemently and any reform achieved has been piecemeal and reluctant. The furore has helped to galvanise robust and extensive intellectual debate on the subject. It ha...

by Craig Paterson

05/13/2010

Chapter one argues for the important contribution that a natural law based framework can make towards an analysis and assessment of key controversies surrounding the practices of suicide, assisted suicide, and voluntary euthanasia. The second chapter considers a number of historical contributions to the debate. The third chapter takes up the modern context of ideas that have increasingly come to the fore in shaping the 'push' for reform. Particular areas focused upon include the value of human life, the value of personal autonomy, and the rejection of double effect reasoning. Chapter four engages in the task of pointing out structural weakness in utilitarianism and deontology. The thesis argues that major systemic weaknesses in both approaches can be overcome by a teleology of ...

Reasons for Disclosure in the Physician-Patient Relationship

How Physician Conduct and Reimbursement Methodologies Lead to Fraud and Abuse in Medicare

by Kathleen Johnson

05/19/2010

The solvency of the Medicare Trust Fund has been debated for the past twenty-five years and despite various stop-gap measures, fraud and abuse continues. Public policy in the form of Stark legislation, anti-kickback laws, and false claims acts were enacted to reduce over-utilization of services and prohibit self-referral and inducements for patients and services. Despite public policy and continued prosecution of fraud, Medicare reimbursement methods fail to control physician conduct of over-utilization and inducements for referrals. Following the concept of the informed consent doctrine and the theory of fiduciary trust in the patient-physician relationship, it is the author's thesis that transparency and disclosure with respect to physician prescription and referral practices can mit...

Unveiling the "Invisibility Cloak"

Investigating the Extent to Which the Kingdom of Thailand's Failure to Address the Issue of Enforced Disappearances Violates Their Responsibility towards the Protection of Basic Human Rights by Comparison with the International Human Rights Jurisprudence

by Sarah M.J. Muzart

04/26/2012

Despite being an act that is widely practiced under the guise of a significant number of States, little is known about the intrinsic realities of enforced disappearances. General literature on the topic is lacking, and laws that address the problem are scarce. Enforced disappearances have only come to the attention of the international community fairly recently. At the dawn of this century, Thailand understandably remains one of the most active countries in the practice of enforcedly disappearing people as a means of removing them from the protection of the law because of no legally justifiable reason for arrest or detention - an ultimate breach of the Rule of Law. This book aims to attribute responsibility to the Kingdom of Thailand for failing to introduce legal mechanisms and safeguard...

by Martin Apistola and Petter Gottschalk

06/27/2012

Knowledge management plays an important role in helping law firms as knowledge organizations create, share and apply knowledge to the needs of law firm clients. This book covers important topics such as characteristics of knowledge, knowledge management systems, objectives and strategies, knowledge processes, change analysis, and change strategy framework. By the same author: Practical Strategies for Effective Law Firm Knowledge Management White-Collar Crime: Detection, Prevention and Strategy in Business Enterprises Policing Financial Crime: Intelligence Strategy Implementation Knowledge Management in Police Oversight: Law Enforcement Integrity and Accountability

Exploring the Vitality of Stare Decisis in America

Debut Symposium Report for The Matthew Fogg Symposia on the Vitality of Stare Decisis in America

by Zena D. Crenshaw-Logal

07/07/2012

Grassroots advocates, public interest attorneys, and legal scholars gathered in October 2011 at the University of Baltimore for the debut symposium of "The Matthew Fogg Symposia On The Vitality of Stare Decisis In America." Convening such a broad and in many ways diverse audience, requires the program series to be worthwhile academically, yet have populist appeal. Towards that end, the event website explains: "It is both scholarly and practical to examine the current vitality of stare decisis as a legal doctrine in America." That we use Latin to describe the concept suggests it is complex, mysterious, and beyond the cares of most Americans. Yet stare decisis, sometimes called the "doctrine of precedent", arguably preserves what is among their most valued treasures, the legitimacy of Am...

by Bethel Erastus-Obilo

07/29/2009

Reason Curve, Jury Competence, and the English Criminal Justice System, a cross-jurisdictional and cross-disciplinary book, seeks to stimulate discussion and extend the debate in the area of criminal trials in light of the absence of an articulated explanation for a verdict. The book traces the history and development of the jury, from the Carolingian kings, its advancement in the English Courts following papal intervention, the impact of the Magna Carta, to its general use, current curtailment in England and Wales, and re-emergence in Continental Europe. Central to the book's submission is the dictum that the jurors' franchise to deliver a cryptic verdict is 'a matter between them and their conscience.' In light of human and civil rights movements, the book advances arguments that a cr...

The Development of International Arbitration on Bilateral Investment Treaties

Disputes Between States and Investor, ICSID Cases Against Turkey Regarding Energy Sector

by Zeynep Akgul, LLM

06/15/2008

This dissertation analyses developments of international arbitration on investment disputes. Recent years, there has been an extraordinary increase in the number of investment arbitration for breach of Bilateral Investment Treaties (BITs). These treaties include substantive and procedural rules to provide investment security and investment neutrality to foreign investor. In particular, most BITs have investor-state dispute settlement provision which allows investors to sue host states directly. Through analyzing the Turkish BIT experience, this study concludes that there are different approaches that utilized in various investor-state dispute settlement provisions. Thus, the wording of these provisions is important. Furthermore, the ICSID arbitration is mostly incorporated into BITs d...

The Development of International Investment Law

Lessons from the OECD MAI Negotiations and Their Application to a Possible Multilateral Agreement on Investment

by Yusuf Caliskan

06/14/2008

This dissertation analyses developments in the international regulation of foreign direct investment (FDI). The international legal framework of investment encompasses numerous binding or non-binding legal instruments, including customary international law, bilateral investment treaties, and international organizations’ decisions and resolutions. The rules established by the international legal framework become effective and significant when they are able to be adapted by appropriate and compatible domestic law frameworks. Through analyzing the Turkish foreign investment regulations and policies, this study concludes that there is a successful and complex interaction between international rules and domestic rules on FDI. Like many developing countries, since the 1980s Turkey has reva...