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FDA and Intellectual Property Strategies for Medical Device Technologies, Gerald B. Halt; John C. Donch; Amber R. Stiles; Li


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Цена: 20962.00р.
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Автор: Gerald B. Halt; John C. Donch; Amber R. Stiles; Li
Название:  FDA and Intellectual Property Strategies for Medical Device Technologies
ISBN: 9783030044619
Издательство: Springer
Классификация:




ISBN-10: 3030044610
Обложка/Формат: Hardcover
Страницы: 333
Вес: 0.71 кг.
Дата издания: 2019
Язык: English
Издание: 1st ed. 2019
Иллюстрации: 5 illustrations, color; 30 illustrations, black and white; xxiv, 333 p. 35 illus., 5 illus. in color.
Размер: 234 x 156 x 21
Читательская аудитория: Professional & vocational
Основная тема: Engineering
Ссылка на Издательство: Link
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Поставляется из: Германии
Описание: 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.
Дополнительное описание: Introduction.- Development of A New Medical Device.- Determining If A Medical Device Technology Is FDA Regulated.- Basic FDA Regulatory Requirements For Medical Devices.- Other Regulatory Consideration For Medical Devices.- Benefits of Having FDA Approval



Intellectual Property: A Very Short Introduction

Автор: Vaidhyanathan Siva
Название: Intellectual Property: A Very Short Introduction
ISBN: 0195372778 ISBN-13(EAN): 9780195372779
Издательство: Oxford Academ
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Цена: от 1138.00 р.
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Описание: Provides a comprehensive and engaging introduction to copyright, patents, trademarks, and other forms of knowledge that are subject to global law and regulation.

Intellectual Property, 5e: Valuation, Infringement , and Joint Venture Strategies

Автор: Russell L. Parr
Название: Intellectual Property, 5e: Valuation, Infringement , and Joint Venture Strategies
ISBN: 1119356210 ISBN-13(EAN): 9781119356219
Издательство: Wiley
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Цена: 45144.00 р.
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Описание:

A new edition of the trusted book on intellectual property

Intellectual Property simplifies the process of attaching a dollar amount to intellectual property and intangible assets, be it for licensing, mergers and acquisitions, loan collateral, investment purposes, and determining infringement damages.

Written by Russell L. Parr, an expert in the valuation/intellectual property field, this book comprehensively addresses IP Valuation, the Exploitation Strategies of Licensing and Joint Ventures, and determination of Infringement Damages. The author explains commonly used strategies for determining the value of intellectual property, as well as methods used to set royalty rates based on investment rates of returns.

This book examines the business economics of strategies involving intellectual property licensing and joint ventures, provides analytical models that can be used to determine reasonable royalty rates for licensing and for determining fair equity splits in joint venture arrangements.

Key concepts in this book are brought to life by presenting real-world examples of exploitation strategies being used by major corporations.

  • Provides practical tools for and examines the business economics for determining the value intellectual property in licensing and joint venture decisions
  • Presents analytical models for determining reasonable royalty rates for licensing and for determining fair equity splits in joint venture arrangements
  • Provides a detailed discussion about determining intellectual property infringement damages focusing on lost profits and reasonable royalties.
Genetic resources in an access and benefit sharing era

Автор: Chidi Oguamanam
Название: Genetic resources in an access and benefit sharing era
ISBN: 1108470769 ISBN-13(EAN): 9781108470766
Издательство: Cambridge Academ
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Цена: 15840.00 р.
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Описание: This collection focuses on Indigenous perspectives on the sharing of traditional knowledge and the exploitation of genetic resources in Canada. This book is for public policy makers, Indigenous communities, environmental policymakers, lawyers, and researchers with a biodiversity, biotechnology, traditional knowledge, or climate change focus. This book is also available as Open Access.

Governing Medical Knowledge Commons

Автор: Katherine J. Strandburg, Brett M. Frischmann, Michael J. Madison
Название: Governing Medical Knowledge Commons
ISBN: 1107146879 ISBN-13(EAN): 9781107146877
Издательство: Cambridge Academ
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Цена: 12514.00 р.
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Описание: This book collects fifteen new case studies documenting successful knowledge and information sharing commons institutions for medical and health sciences innovation. Also available as Open Access.

Health Technologies and International Intellectual Property Law: A Precautionary Approach

Автор: Li Phoebe
Название: Health Technologies and International Intellectual Property Law: A Precautionary Approach
ISBN: 1138937584 ISBN-13(EAN): 9781138937581
Издательство: Taylor&Francis
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Цена: 6583.00 р.
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Описание:

The global transmission of infectious diseases has fuelled the need for a more developed legal framework in international public health to provide prompt and specific guidance during a large-scale emergency. This book develops a means for States to take advantage of the flexibilities of compulsory licensing in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which promotes access to medicines in a public health emergency. It presents the precautionary approach (PA) and the structure of risk analysis as a means to build a workable reading of TRIPS and to help States embody the flexibilities of intellectual property (IP).

The work investigates the complementary roles of the World Health Organization (WHO) and the World Trade Organization (WTO) in order to promote the harmonisation of the precautionary approach in relation to the patenting of crucial pharmaceutical products. By bringing together international trade law and intellectual property law Phoebe Li demonstrates how through the use of risk analysis and the precautionary approach, States can still comply with their legal obligations in international law, while exercising their sovereignty right in issuing a compulsory licence of a drug patent in an uncertain public health emergency.

This book will be of great interest to students and academics of medical and healthcare law, intellectual property law, international trade law, and human rights law.

Intellectual Property and Financing Strategies for Technology Startups

Автор: Halt, Jr.
Название: Intellectual Property and Financing Strategies for Technology Startups
ISBN: 3319492160 ISBN-13(EAN): 9783319492162
Издательство: Springer
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Цена: 20962.00 р.
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Описание: This book offers a comprehensive, easy to understand guide for startup entities and developing companies, providing insight on the various sources of funding that are available, how these funding sources are useful at each stage of a company’s development, and offers a comprehensive intellectual property strategy that parallels each stage of development. The IP strategies offered in this book take into consideration the goals that most startups and companies have at each stage of development, as well as the limitations that exist at each stage (i.e., limited available resources earmarked for intellectual property asset development), and provides solutions that startups and companies can implement to maximize their return on intellectual property investments. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by startups and companies across all industries. Readers will garner an appreciation for the value that intellectual property rights provide to a startup entity or company and will gain an understanding of the types of intellectual property rights that are available to companies and how to procure, utilize and monetize those intellectual property rights to help their company grow.

Comparative Defamation and Privacy Law

Автор: Kenyon Andrew T.
Название: Comparative Defamation and Privacy Law
ISBN: 1107559189 ISBN-13(EAN): 9781107559189
Издательство: Cambridge Academ
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Цена: 6019.00 р.
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Описание: Defamation and privacy, major and interrelated issues for law and media, are examined here by experts from common law jurisdictions. Aimed at a wide legal audience, this book will be of interest to all those working on commonwealth or US law, as well as scholars from wider jurisdictions.

Cambridge International Trade and Economic Law

Автор: Hsu Locknie
Название: Cambridge International Trade and Economic Law
ISBN: 1107421039 ISBN-13(EAN): 9781107421035
Издательство: Cambridge Academ
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Цена: 6970.00 р.
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Описание: Locknie Hsu brings together current trade, investment, innovation, intellectual property, competition and public health issues that impact upon access to medicines in Asia. This book will be useful to academic researchers, regulators, law-makers and global organizations involved in the issue of access to medicines.

Patents on life

Название: Patents on life
ISBN: 1108428681 ISBN-13(EAN): 9781108428682
Издательство: Cambridge Academ
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Цена: 16474.00 р.
Наличие на складе: Поставка под заказ.

Описание: Brings legal, religious, ethical, and political perspectives to bear on debates about biotechnology patents or `patents on life`. With international, interfaith, and cross-disciplinary contributions, it will appeal to legal scholars, policymakers, advocates, and religious ethicists and leaders working in the area of social ethics and justice.

Drugs, Money, and Secret Handshakes: The Unstoppable Growth of Prescription Drug Prices

Автор: Robin Feldman
Название: Drugs, Money, and Secret Handshakes: The Unstoppable Growth of Prescription Drug Prices
ISBN: 1108482457 ISBN-13(EAN): 9781108482455
Издательство: Cambridge Academ
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Цена: 6334.00 р.
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Описание: Feldman explains the secretive world of drug pricing deals that push patients into more expensive drugs. This book is intended for an audience of policymakers, scholars, jurists, higher education students, journalists, and general interest readers and aims to provide an accessible, easy-to-read tour of issues faced by the pharmaceutical industry.

Big data, health law, and bioethics

Автор: Edited By I. Glenn C
Название: Big data, health law, and bioethics
ISBN: 1107193656 ISBN-13(EAN): 9781107193659
Издательство: Cambridge Academ
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Цена: 24077.00 р.
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Описание: This book explores the legal and ethical implications - both challenges and opportunities - of using big data in health care and research.

Identity, Invention, and the Culture of Personalized Medicine Patenting

Автор: Ghosh
Название: Identity, Invention, and the Culture of Personalized Medicine Patenting
ISBN: 1107655773 ISBN-13(EAN): 9781107655775
Издательство: Cambridge Academ
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Цена: 5069.00 р.
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Описание: This book provides an overview of developments in personalized medicine patenting, which develops medical treatments tailored to individuals based on race and other characteristics. The book explores the normative implications of personalized medicine patenting and suggests ways to best regulate policies.


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