AHLA The Fundamentals of Life Sciences Law (Non-Members)

AHLA The Fundamentals of Life Sciences Law (Non-Members)

Author:

Publisher:

Published: 2016

Total Pages:

ISBN-13: 9781630440176

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The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech, Second Edition, provides a solid grounding in the legal principles and issues inherent in this complex area. Both new practitioners and experienced attorneys alike will benefit from this unparalleled coverage.This new edition features contributions from some of the most experienced and respected practitioners of life sciences and health law. Whether you're looking for an introduction to this area, or you need a go-to reference on your shelf, the coverage includes:Regulation of DrugsRegulation of Medical DevicesRegulation of BiologicsClinical TrialsFraud and AbuseFederal AgenciesRegulation of Advertising, and Promotion of Drugs, Medical Devices, and BiologicsAntitrustPrivacyState RegulationIntellectual PropertyPayment and ReimbursementInternational IssuesLife Sciences Licensing Transaction


The Fundamentals of International Human Rights Treaty Law

The Fundamentals of International Human Rights Treaty Law

Author: Bertrand G. Ramcharan

Publisher: Martinus Nijhoff Publishers

Published: 2011-02-14

Total Pages: 305

ISBN-13: 900417608X

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This book has a simple objective: to present the fundamentals of international human rights treaty law in a way that can be helpful to the national leader, official, or legal adviser whose duty it is to help put a human rights treaty regime into the law and practice in his or her country. It is a book of international law, as provided for in the principal international and regional human rights treaties and draws upon the jurisprudence and practice of their monitoring organs.


Fundamentals of Transfer Pricing

Fundamentals of Transfer Pricing

Author: Michael Lang

Publisher:

Published: 2019

Total Pages: 0

ISBN-13: 9789041189943

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Transfer pricing continues to be one of the most significant areas of heightened controversy in international taxation for multinational enterprises and tax administrations. Due to its far-reaching consequences, tax professionals and individual tax jurisdictions are required to understand the fundamentals of the topic, which is often caught in a maze of literature. Emerging from the joint research conducted by the WU Transfer Pricing Center at the Institute for Austrian and International Tax Law at WU (Vienna University of Economics and Business), the international tax law firm L&P - Ludovici Piccone & Partners, and the experiences from the annual advanced transfer pricing courses and conferences, this first edition of the book acts as a manual for understanding transfer pricing principles and their practical application. It provides a balanced approach by first detailing the basics of transfer pricing and second proceeding to specific topics that are highly relevant in today's tax environment. In analysing the topics, the work undertaken by the OECD, UN, EU, World Customs Organization, World Bank, International Monetary Fund and other international organizations is considered. Moreover, the book contains several practical examples, judicial precedents and illustrative explanations to complement the understanding.


AHLA Health Care Compliance Legal Issues Manual (Non-members)

AHLA Health Care Compliance Legal Issues Manual (Non-members)

Author: American Health Lawyers Association

Publisher:

Published: 2019

Total Pages:

ISBN-13: 9781522173441

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Authored by experts with years of health care compliance experience, this new edition integrates changes in regulation, trends in enforcement, and the reasoning of the courts to help you navigate emerging and unsettled areas of compliance risk, such as self-disclosure obligations, risks associated with opioid use, and the impact of statistical sampling.Highlights of this edition include:All new glossary of health care compliance terms, including key statutes, acronyms, governing agencies, and moreExpanded civil monetary penalty and exclusion authorities under 2017 final rulesDiscussion of core elements of compliance programs for Medicare Advantage Plans and Part D Plans as established by federal regulationsExpanded whistleblower protections under federal and state law, false claims based on lack of medical necessity, materiality after Escobar, and recent enforcement activityExpanded discussion of determinations of medical necessity, CMS review of medical necessity terminations, consequences, and appeals processesRecent health information privacy and security developments, including new guidance, risks associated with innovative technologies, and trends in Health Insurance Portability and Accountability Act (HIPAA) enforcement activityNew chapters:Chapter 1, Glossary of Key TermsChapter 10, The Relationship between Enforcement and ComplianceChapter 17, Health Care Civil Rights and Nondiscrimination Under Section 1557 of the Affordable Care ActChapter 19, Behavioral Health


Introduction to Biological Physics for the Health and Life Sciences

Introduction to Biological Physics for the Health and Life Sciences

Author: Kirsten Franklin

Publisher: John Wiley & Sons

Published: 2010-08-13

Total Pages: 468

ISBN-13: 9780470711392

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This book aims to demystify fundamental biophysics for students in the health and biosciences required to study physics and to understand the mechanistic behaviour of biosystems. The text is well supplemented by worked conceptual examples that will constitute the main source for the students, while combining conceptual examples and practice problems with more quantitative examples and recent technological advances.


The Medical Device R&D Handbook, Second Edition

The Medical Device R&D Handbook, Second Edition

Author: Theodore R. Kucklick

Publisher: CRC Press

Published: 2012-12-05

Total Pages: 513

ISBN-13: 143981189X

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Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designers to apply these specialized techniques for greater innovation and time saving. The author discusses the historical background of various technologies, helping readers understand how and why certain devices were developed. The text also contains interviews with leaders in the industry who offer their vast experience and insights on how to start and grow successful companies—both what works and what doesn’t work. This updated and expanded edition adds new information to help meet the challenges of the medical device industry, including strategic intellectual property management, operating room observation protocol, and the use of new technologies and new materials in device development.


Fundamentals of Sociology

Fundamentals of Sociology

Author: Vidya Bhushan

Publisher: Pearson Education India

Published: 2012

Total Pages: 309

ISBN-13: 8131799670

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Fundamentals of Sociology is a textbook for undergraduate students of sociology. This book comprehensively explains the basics of sociology, including social concepts, institutions and the theories of prominent thinkers. Importance has also been given to various important approaches to sociology, including women and society, social change and the role of social legislation in social change. The book is designed keeping in mind the students' needs. Therefore, every unit is divided into chapters, which are further divided into subtopics. Every chapter ends with a number of questions for the students' practice. The book contains an exhaustive list of suggested readings for students who wish to explore this subject further.