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


Book Description

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


Book Description

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.







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


Book Description

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




Fundamentals of Transfer Pricing


Book Description

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.







The Medical Device R&D Handbook, Second Edition


Book Description

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.




Introduction to Biological Physics for the Health and Life Sciences


Book Description

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.




Fundamentals of Lawyer Leadership


Book Description

Buy a new version of this textbook and receive access to the Connected eBook on Casebook Connect, including lifetime access to the online ebook with highlight, annotation, and search capabilities. Access also includes an outline tool and other helpful resources. Connected eBooks provide what you need most to be successful in your law school classes. In Fundamentals of Lawyer Leadership: A Skills Guide to Professional Identity Formation, we explore the aspects of leadership and professional identity formation that take root and begin to grow while students are in law school and throughout their lifelong journey as practicing attorneys and professionals. We like to describe professional identity and its formation as the process of becoming a complete lawyer; however, honing the skill sets of a complete lawyer takes time and study. Just as developing legal skills is a life-long endeavor, growing as a leader is a process that evolves over a lifetime. To become whole, healthy, skilled professionals, it is imperative that lawyers engage in a process of lifelong learning. That journey begins in law school, where professors help guide students not only in the formation of their professional identities, but also to develop as effective, thoughtful leaders. This process is vital, not merely as an ABA requirement, but to ensure the future of the profession. For students to develop as both professionals and leaders requires a personal, practical, and reflective approach to the issues. This ownership of continuous professional growth toward excellence, grounded in a service-oriented approach is a cornerstone of preparedness for leadership, and therefore, development as a lawyer. This textbook begins with professional identity formation and foundational leadership and what each means. In Part II, Leadership of Self: Growing into Leadership, the leadership journey requires looking inward to examine who you are, what type of lawyer you want to be, and how you will lead. In Part III, Leadership with Others: Effective Group Dynamics, the book covers topics such as building and nurturing relationships, developing emotional and cultural intelligence, becoming a valuable member of teams, civility, civil discourse, and creating inclusive environments. Finally, in Part IV, Leadership within Community: Service and Impact, the book examines the role of the lawyer in society, including crisis management, how to be prepared for moments of opportunity, and how you can use your skills to have influence and impact others. Contributing your energy to worthy causes about which you are passionate will bring purpose and satisfaction to your life. The authors are available to advise any law school faculty who plan to teach a leadership course and would be happy to discuss the lessons they’ve learned in teaching leadership. Their contact information will be provided upon request. Highlights of Second Edition: Incorporates more clearly the ABA’s requirements for professional identity formation (PIF) Discusses the intersection of that concept with leadership Provides a practical skills approach to becoming a professional Includes an overview of lawyers’ professional identity and formation as a first step to influence and impact through leadership Adds material on new topics, including: Civility and Civil Discourse Character Development o Addressing Fear, Failure, and Feedback Preparing for the future through innovation Design theory Technology The business of lawyering and marketing/branding Addresses the disruptions facing the profession (via changes such as artificial intelligence) and suggests a way forward Takes a fresh look at the issues facing those who would join the profession and gives meaningful, relevant guidance to prepare lawyers to be their best as they serve their clients and communities Professors and students will benefit from: A modular nature due to its multipartite organization, making the book uniquely adaptable for different settings, including: Leadership as a full course, incorporating a module into doctrinal courses, or providing leadership training in a professional development setting, and more A roadmap for teaching these concepts in an easy-to-understand manner that allows for flexibility and adaptability via its teaching framework A book and comprehensive resources written and designed for both new and experienced professors The emphasis of the themes of life-long professional development, lawyers’ ethical obligations, and service throughout




Fundamentals of Sociology


Book Description

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.