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  • FDA and Intellectual Property Strategies for Medical Device Technologies

    Series series Engineering (R0)
    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 ... Read more

    $153.99 CAD

  • FDA and Intellectual Property Strategies for Medical Device Technologies

    Including Artificial Intelligence, Software and Applications

    Series series Engineering (R0)
    This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States Food and Drug Administration (US FDA) regulatory review and approval/grant/clearance 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 ... Read more

    $153.99 CAD

  • Intellectual Property in Consumer Electronics, Software and Technology Startups

    Series series Engineering (R0)
    This book provides a comprehensive guide to procuring, utilizing and monetizing intellectual property rights, tailored for readers in the high-tech consumer electronics and software industries, as well as technology startups. Numerous, real examples, case studies and scenarios are incorporated throughout the book to illustrate the topics discussed. Readers will learn what to consider throughout ... Read more

    $115.99 CAD

  • Intellectual Property and Financing Strategies for Technology Startups

    Series series Engineering (R0)
    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 ... Read more

    $128.99 CAD

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  • Clinical Research Coordinator Handbook, 5th edition

    “This extremely useful title is written for anyone planning to implement clinical trials at an institution. … the author has carefully detailed the types of forms, study records, and case report forms. … A powerful appendix and glossary of relevant terms help make this a needed book for any clinical trials office.”— Journal of Hospital LibrarianshipIn this fully revised and expanded fifth edition ... Read more

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  • Cobert's Manual of Drug Safety and Pharmacovigilance

    Cobert's Manual of Drug Safety and Pharmacovigilance, Fourth Edition, is an updated how-to manual of guiding principles and concepts for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and the practicalities of ... Read more

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  • Supply Chain Management in the Drug Industry

    Delivering Patient Value for Pharmaceuticals and Biologics

    by Hedley Rees ...
    This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners ... Read more

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  • The Combination Products Handbook

    A Practical Guide for Combination Products and Other Combined Use Systems

    Edited by Susan Neadle ...
    Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled ... Read more

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  • Logistics Operations and Management

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  • The Survival Guide to EU Medical Device Regulations

    The Regulations for medical devices and in vitro diagnostic medical devices were published in the Official Journal of the European Union on 5 May 2017, and they entered into force 26 May 2017. A regulation is a legal act of the European Union that becomes immediately enforceable as law in all Member States simultaneously. This book gives guidance on the definitions, the key concepts and the main ... Read more

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  • Risky Business: Sharing Health Data While Protecting Privacy

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