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Author: Fred A. Kuglin
Publisher: CRC Press
ISBN: 1482258943
Category : Business & Economics
Languages : en
Pages : 204
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Book Description
Error-proofing in the production process of pharmaceuticals isn‘t just a matter of good business, it has life-and-death implications for consumers. The 2013 Drug Quality and Security Act introduces more stringent compliance factors towards this common goal, in large part requiring new mandates on tracking and tracing chain of custody in the supply chain. This book comprehensively overviews the new mandate and its implications, including implementation strategies for track-and-trace programs along with presenting a fuller understanding of the mechanics of intergovernmental policies and oversights.
Author: Fred A. Kuglin
Publisher: CRC Press
ISBN: 1482258943
Category : Business & Economics
Languages : en
Pages : 204
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Book Description
Error-proofing in the production process of pharmaceuticals isn‘t just a matter of good business, it has life-and-death implications for consumers. The 2013 Drug Quality and Security Act introduces more stringent compliance factors towards this common goal, in large part requiring new mandates on tracking and tracing chain of custody in the supply chain. This book comprehensively overviews the new mandate and its implications, including implementation strategies for track-and-trace programs along with presenting a fuller understanding of the mechanics of intergovernmental policies and oversights.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309269393
Category : Medical
Languages : en
Pages : 377
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Book Description
The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
Author: Nozari, Hamed
Publisher: IGI Global
ISBN: 1522559221
Category : Business & Economics
Languages : en
Pages : 399
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Book Description
In a rapidly growing global economy, where there is a constant emergence of new business models and dynamic changes to the business ecosystem, there is a need for the integration of traditional, new, and hybrid concepts in the complex structure of supply chain management. Within the fast-paced pharmaceutical industry, product strategy, life cycles, and distribution must maintain the highest level of agility. Therefore, organizations need strong supply chain capabilities to profitably compete in the marketplace. Global Supply Chains in the Pharmaceutical Industry provides innovative insights into the efforts needed to build and maintain a strong supply chain network in order to achieve efficient fulfillment of demand, drive outstanding customer value, enhance organizational responsiveness, and build network resiliency. This publication is designed for supply chain managers, policymakers, researchers, academicians, and students, and covers topics centered on economic cycles, sustainable development, and new forces in the global economy.
Author: United States. Congress. House. Committee on Government Reform. Subcommittee on Criminal Justice, Drug Policy, and Human Resources
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 136
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Book Description
Author: Roger Bate
Publisher: AEI Press
ISBN: 0844772348
Category : Business & Economics
Languages : en
Pages : 489
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Book Description
Roger Bate has spend years on the trail of counterfeit medicines in Asia, Africa, and the Middle East, learning the anatomy of a nebulous, far-reaching black market that has resulted in countless deaths and injuries around the world. Phake: The Deadly World of Falsified and Substandard Medicines is the culmination of Bate's research and travels—both a fascinating first hand account of the counterfeit drug trade and an incisive policy analysis with important ramifications for decision makers in the U.S. Food and Drug Administration and the international World Health Organization.
Author: Ravendra Singh
Publisher: Elsevier
ISBN: 0444639667
Category : Technology & Engineering
Languages : en
Pages : 700
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Book Description
Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes. Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering. - Introduces Process System Engineering (PSE) methods and tools for discovering, developing and deploying greener, safer, cost-effective and efficient pharmaceutical production processes - Includes a wide spectrum of case studies where different PSE tools and methods are used to improve various pharmaceutical production processes with distinct final products - Examines the future benefits and challenges for applying PSE methods and tools to pharmaceutical manufacturing
Author: Steven Carnovale
Publisher: World Scientific
ISBN: 9811233136
Category : Business & Economics
Languages : en
Pages : 235
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Book Description
What are the cyber vulnerabilities in supply chain management? How can firms manage cyber risk and cyber security challenges in procurement, manufacturing, and logistics?Today it is clear that supply chain is often the core area of a firm's cyber security vulnerability, and its first line of defense. This book brings together several experts from both industry and academia to shine light on this problem, and advocate solutions for firms operating in this new technological landscape.Specific topics addressed in this book include: defining the world of cyber space, understanding the connection between supply chain management and cyber security, the implications of cyber security and supply chain risk management, the 'human factor' in supply chain cyber security, the executive view of cyber security, cyber security considerations in procurement, logistics, and manufacturing among other areas.
Author: Martha A. Embrey
Publisher:
ISBN: 9781565495876
Category : Drugs
Languages : en
Pages : 0
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Book Description
Managing Drug Supply (MDS) is the leading reference on how to manage essential medicines in developing countries. MDS was originally published in 1982; it was revised in 1997 with over 10,000 copies distributed in over 60 countries worldwide. The third edition, MDS-3: Managing Access to Medicines and Health Technologies reflects the dramatic changes in politics and public health priorities, advances in science and medicine, greater focus on health care systems, increased donor funding, and the advent of information technology that have profoundly affected access to essential medicines over the past 14 years. Nearly 100 experts from a wide range of disciplines and virtually every corner of the world have contributed to this third edition. In addition to many new country studies, references, and extensive revisions, MDS-3 offers new chapters on areas such as pharmaceutical benefits in insurance programs, pricing, intellectual property, drug seller initiatives, and traditional and complementary medicine. The revisions and new chapters echo the wide variety of issues that are important to health practitioners and policy makers today. MDS-3 will be a valuable tool in the effort to ensure universal access to quality medicines and health technologies and their appropriate use.
Author: Hedley Rees
Publisher: John Wiley & Sons
ISBN: 0470922842
Category : Medical
Languages : en
Pages : 458
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Book Description
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 and other relevant parties to help secure responsive, cost effective and risk mitigated supply chains to compete on a world stage. This should not wait until a drug has been registered, but should start as early as possible in the development process and before registration or clinical trials. The author suggests that CMC (chemistry manufacturing controls) drug development must reset the line of sight – from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. Capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste. All these factors can and should be addressed at the CMC development stage.
Author: Pethuru Raj Chelliah
Publisher: Engineering Science Reference
ISBN: 9781799883678
Category : Artificial intelligence
Languages : en
Pages :
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Book Description
"This book articulates and accentuates various AI algorithms, fresh innovations in the IoT and blockchain spaces explaining how suggested AI algorithms come in handy in producing predictive and prescriptive insights out of big data"--
