In Vitro Diagnostic Industry in China
In Vitro Diagnostic Industry in China

Author: Haibo Song

Publisher: Springer Nature

Published: 2021-07-28

Total Pages: 287

ISBN-13: 9811623163

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This book systematically describes the achievements and current situation of in vitro diagnostic (IVD) industry in China. It consists of eight parts, including the overview on the IVD industry in China in 2019, hot technologies and products of IVD industry, academic, technological and product development in the field of IVD, such as biochemical diagnosis, immune-diagnosis, molecular diagnosis, blood and body fluid diagnosis, microbial detection, point-of-care testing, laboratory assembly line, etc. This book is compiled by an editorial committee composed of well-known entrepreneurs, experts and professors in IVD industry in China. It is a reference book for practitioners of IVD industry, medical laboratory and medical staffs all over the world.

In Vitro Diagnostic Industry in China
In Vitro Diagnostic Industry in China

Author: Haibo Song

Publisher: Springer Nature

Published: 2024-01-09

Total Pages: 580

ISBN-13: 981993110X

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This book systematically describes the achievements and current situation of in vitro diagnostic (IVD) industry in China. It consists of twelve parts, including the overview on the IVD industry in China in 2021, hot technologies and products of IVD industry, academic, technological and product development in the field of IVD, such as biochemical diagnosis, immune-diagnosis, point-of-care testing, molecular diagnosis, blood and body fluid diagnosis, microbial detection, laboratory assembly line, etc. In this second edition, the new contents added include the development of new coronavirus molecular diagnostic products, flight mass spectrometry, tandem mass spectrometry, tumor markers, ELISA immune reagents, autoimmune diagnostics, concomitant diagnosis, fecal and intestinal microecology detection, pathological diagnosis, raw materials for in vitro diagnostic reagents, standard substances and quality controls for in vitro diagnostic reagents, etc., making the content of the whole book more novel and rich. This book is compiled by an editorial committee composed of well-known entrepreneurs, experts and professors in IVD industry in China. It is a reference book for practitioners of IVD industry, medical laboratory and medical staffs all over the world.

Approaching China's Pharmaceutical Market
Approaching China's Pharmaceutical Market

Author: Ming Q. Lu

Publisher: Springer

Published: 2015-07-30

Total Pages: 657

ISBN-13: 3319155768

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​This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registration process, it explores the differences between the China Food and Drug Administration (CFDA)—including its regulations and registration procedures—and those of the Western world. The volume discusses disparities between China's application requirements compared to Western standards to make it easier for companies to prepare their application packages. It also provides detailed commentary on CFDA guidelines in reference to clinical trial (IND) and market application (NDA) requirements. Overall, this book offers guidance for Western companies aspiring to expand into China’s pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future issues.

China's Healthcare System and Reform
China's Healthcare System and Reform

Author: Lawton Robert Burns

Publisher: Cambridge University Press

Published: 2017-01-26

Total Pages: 744

ISBN-13: 1316738396

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This volume provides a comprehensive review of China's healthcare system and policy reforms in the context of the global economy. Following a value-chain framework, the 16 chapters cover the payers, the providers, and the producers (manufacturers) in China's system. It also provides a detailed analysis of the historical development of China's healthcare system, the current state of its broad reforms, and the uneasy balance between China's market-driven approach and governmental regulation. Most importantly, it devotes considerable attention to the major problems confronting China, including chronic illness, public health, and long-term care and economic security for the elderly. Burns and Liu have assembled the latest research from leading health economists and political scientists, as well as senior public health officials and corporate executives, making this book an essential read for industry professionals, policymakers, researchers, and students studying comparative health systems across the world.

In Vitro Diagnostic Industry in China
In Vitro Diagnostic Industry in China

Author: Haibo Song

Publisher:

Published: 2021

Total Pages: 0

ISBN-13: 9789811623172

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This book systematically describes the achievements and current situation of in vitro diagnostic (IVD) industry in China. It consists of eight parts, including the overview on the IVD industry in China in 2019, hot technologies and products of IVD industry, academic, technological and product development in the field of IVD, such as biochemical diagnosis, immune-diagnosis, molecular diagnosis, blood and body fluid diagnosis, microbial detection, point-of-care testing, laboratory assembly line, etc. This book is compiled by an editorial committee composed of well-known entrepreneurs, experts and professors in IVD industry in China. It is a reference book for practitioners of IVD industry, medical laboratory and medical staffs all over the world.

First WHO Model List of Essential In Vitro Diagnostics
First WHO Model List of Essential In Vitro Diagnostics

Author: World Health Organization

Publisher: World Health Organization

Published: 2019-05-16

Total Pages: 73

ISBN-13: 9241210265

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The objective of the list is to help countries develop or update their national essential diagnostics lists, raise awareness and political will, guide procurement and regulation policies and improve access to the most important in vitro diagnostics that all countries need to make available to their populations, particularly in low-resourced countries. It will also contribute towards health systems strengthening and realizing universal health coverage.

Companion and Complementary Diagnostics
Companion and Complementary Diagnostics

Author: Jan Trøst Jørgensen

Publisher: Academic Press

Published: 2019-05-08

Total Pages: 509

ISBN-13: 0128135409

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Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies. - Covers all aspects, from biomarker discovery, to development and regulatory approval - Explains the "how to" aspects of companion diagnostics - Incorporates information on the entire process, allowing for easier and deeper understanding of the topic

Commentary on the UN Sales Law (CISG)
Commentary on the UN Sales Law (CISG)

Author: Christoph Brunner

Publisher: Kluwer Law International B.V.

Published: 2019-03-18

Total Pages: 923

ISBN-13: 9041199799

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Buyers and sellers engaging in the cross-border sale of goods are well-advised to be conversant with the United Nations Convention on Contracts for the International Sale of Goods (CISG), which governs international sales contracts. The CISG has been ratified by 89 states, which together account for over three-quarters of all world trade. This practically-oriented, article-by-article commentary on the CISG will be useful to legal practitioners, counsel and arbitrators dealing with international sales contracts. The in-depth annotations deal extensively with the legal issues likely to arise under each CISG article. The annotations include up-to-date analyses of state court and arbitral decisions, the legal doctrines derived from these decisions, and relevant scholarship to date. Among the issues and topics discussed are the following: interface with national laws; scope of application; obligations of seller and buyer; non-conforming goods and duty to notify; breach of contract and remedies; damages; force majeure exemption; and termination of contract and its consequences. This book is an updated translation of the second German edition of a valued resource in Germany, Switzerland, and Austria, and an authority regularly cited by the Swiss Supreme Court. The commentary is influenced by legal authorities from both civil law and common law backgrounds. Throughout, the contributors refer to the cisg-online.ch database, enabling users to locate decisions easily. User-friendly, focused on practical questions, concise but comprehensive, this article-by-article commentary provides a quick and trenchant overview of existing legal opinions and court/arbitral decisions. It will prove immensely valuable to legal practitioners, facilitating their formulation of reliable solutions to legal problems involving the CISG.

Public Health Effectiveness of the FDA 510(k) Clearance Process
Public Health Effectiveness of the FDA 510(k) Clearance Process

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2010-10-04

Total Pages: 141

ISBN-13: 0309162904

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The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.