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  • 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 ... Leer más

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  • Clinical Research Coordinator Handbook, Fourth Edition

    In this fully revised and expanded fourth edition of the essential reference for clinical research coordinators, Deborrah Norris provides expanded coverage of CRC duties and regulatory requirements, including new sections on investigator responsibilities, data clarification, and adverse event reporting. The books five appendices include a directory of CRC resources, updated forms and checklists, ... Leer más

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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 ... Leer más

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  • Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)

    Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual 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 drug safety ... Leer más

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  • Supply Chain Management in the Drug Industry

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    de Hedley Rees ...
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  • The Combination Products Handbook

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    Edición de 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 ... Leer más

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  • Logistics Operations and Management

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    This book provides a comprehensive overview of how to strategically manage the movement and storage of products or materials from any point in the manufacturing process to customer fulfillment. Topics covered include important tools for strategic decision making, transport, packaging, warehousing, retailing, customer services and future trends. - An introduction to logistics - Provides practical ... Leer más

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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 ... Leer más

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  • Risky Business: Sharing Health Data While Protecting Privacy

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  • Medical Device

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  • The ASQ Certified Medical Device Auditor Handbook

    Edición de Scott A. Laman ...
    The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified ... Leer más

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  • Regulatory Aspects of Pharmaceutical Quality System

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    If you're a B. Pharm or M. Pharm student seeking a comprehensive yet concise guide to the regulatory aspects of pharmaceutical quality systems, look no further than Regulatory Aspects of Pharmaceutical Quality System – Brief Introduction. While other textbooks on quality assurance cover a variety of topics to varying degrees of depth, this book provides a unified approach that is both insightful ... Leer más

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