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FDA and Intellectual Property Strategies for Medical Device Technologies

Including Artificial Intelligence, Software and Applications

de Gerald B. Halt, Jr., John C. Donch, Jr., Amber R. Stiles, Brandon R. Theiss, Michelle Byrne, William F. Hodnick, Joshua Eldridge, Randy Goodman, Lisa Jenkins VanLuvanee, Dana L. Blue ...

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

$2,207 MXN

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
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Clinical Research Coordinator Handbook, Fourth Edition

de Deborah Norris ...

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

$172 MXN o gratis con Kobo Plus

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,
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Clinical Research Coordinator Handbook, 5th edition

de Deborrah Norris ...

“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

$172 MXN o gratis con Kobo Plus

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

de Barton Cobert, William Gregory, Jean-loup Thomas ...

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

$712 MXN

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
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Supply Chain Management in the Drug Industry

Delivering Patient Value for Pharmaceuticals and Biologics

de 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 ... Leer más

$1,588 MXN

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
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The Combination Products Handbook

A Practical Guide for Combination Products and Other Combined Use Systems

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

$1,359 MXN

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
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Logistics Operations and Management

Concepts and Models

Edición de Reza Farahani, Shabnam Rezapour, Laleh Kardar ...

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

$1,795 MXN

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
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Risky Business: Sharing Health Data While Protecting Privacy

Edición de Khaled El Emam ...

Due to the digitization of medical records, more and more health data is readily available. This dynamic has created many opportunities to unlock this information and use it to improve medical practice, and through research and surveillance understand the effectiveness and side effects of drugs and medical devices to ultimately improve the public’s health. This data can also be used for commercial ... Leer más

$69 MXN

Due to the digitization of medical records, more and more health data is readily available. This dynamic has created many opportunities to unlock this information and use it to improve medical practice, and through research and surveillance understand the effectiveness and side effects of drugs and medical devices to ultimately improve the public’s health. This data can also be used for commercial
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Medical Device

A Primer Based on Best Practices

de Rommel Garcia ...

This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who ... Leer más

$69 MXN

This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who
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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

$2,323 MXN

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
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Regulatory Aspects of Pharmaceutical Quality System

Brief Introduction

de Arun Kumar Pandey ...

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

$1,049 MXN o gratis con Kobo Plus

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
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Medical Devices

Regulations, Standards and Practices

de Seeram Ramakrishna, Lingling Tian, Charlene Wang, Susan Liao, Wee Eong Teo ...

Series series Woodhead Publishing Series in Biomaterials
Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new ... Leer más

$2,572 MXN

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new
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Engineering (R0) Serie de eBooks

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Clinical Research Coordinator Handbook, Fourth Edition

Clinical Research Coordinator Handbook, 5th edition

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

Supply Chain Management in the Drug Industry

The Combination Products Handbook

Logistics Operations and Management

Risky Business: Sharing Health Data While Protecting Privacy

Medical Device

The ASQ Certified Medical Device Auditor Handbook

Regulatory Aspects of Pharmaceutical Quality System

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