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Author: Publisher: World Health Organization ISBN: 9240021329 Category : Business & Economics Languages : en Pages : 52
Book Description
This policy paper outlines the features of existing traceability systems and provides guidance on developing workable traceability regulation. In the light of the widely varying needs, capacity, and resources of Member States, the risk mitigation and sustainability strategies embedded in implementation efforts will vary. Given the range of possible implementation pathways, a set of guiding principles will assist Member States in establishing systems best suited to their needs and constraints.
Author: Publisher: World Health Organization ISBN: 9240021329 Category : Business & Economics Languages : en Pages : 52
Book Description
This policy paper outlines the features of existing traceability systems and provides guidance on developing workable traceability regulation. In the light of the widely varying needs, capacity, and resources of Member States, the risk mitigation and sustainability strategies embedded in implementation efforts will vary. Given the range of possible implementation pathways, a set of guiding principles will assist Member States in establishing systems best suited to their needs and constraints.
Author: Michael Cheng Publisher: World Health Organization ISBN: 9241546182 Category : Medical Languages : en Pages : 54
Book Description
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Author: OECD Publisher: OECD Publishing ISBN: 9264431683 Category : Languages : en Pages : 145
Book Description
This report offers insights into the risks and vulnerabilities of the supply chains of medicines and medical devices. Policy options to anticipate and mitigate risks of shortages of medicines and medical devices, both routinely and in the context of severe crises, are analysed. Most importantly, the report shows that strengthening the long-term resilience of medical supply chains requires collaborative approaches that balance measures best undertaken by the private sector with those more appropriately managed by governments or supranationally.
Author: World Health Organization Publisher: World Health Organization ISBN: 9241564040 Category : Medical Languages : en Pages : 147
Book Description
Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
Author: Jane Huang Publisher: Springer Science & Business Media ISBN: 1447122380 Category : Computers Languages : en Pages : 495
Book Description
Software and Systems Traceability provides a comprehensive description of the practices and theories of software traceability across all phases of the software development lifecycle. The term software traceability is derived from the concept of requirements traceability. Requirements traceability is the ability to track a requirement all the way from its origins to the downstream work products that implement that requirement in a software system. Software traceability is defined as the ability to relate the various types of software artefacts created during the development of software systems. Traceability relations can improve the quality of a product being developed, and reduce the time and cost of development. More specifically, traceability relations can support evolution of software systems, reuse of parts of a system by comparing components of new and existing systems, validation that a system meets its requirements, understanding of the rationale for certain design and implementation decisions, and analysis of the implications of changes in the system.
Author: Borah, Malaya Dutta Publisher: IGI Global ISBN: 1799896072 Category : Computers Languages : en Pages : 289
Book Description
Health information about any patent is extremely critical. As there are many malicious users and misuses of health data, this information is not shared amongst health organizations due to security and privacy issues. Blockchain is being explored as a platform for securely exchanging healthcare data among the organizations in public domains, allowing doctors and practitioners to have access to more comprehensive health histories and in turn provide better care to patients. Prospects of Blockchain Technology for Accelerating Scientific Advancement in Healthcare disseminates the recent research findings on blockchain in healthcare and reviews current state-of-the-art blockchain applications in healthcare. This book also discusses various challenges faced by the healthcare community in securing healthcare data. Covering topics such as consensus mechanisms, smart healthcare systems, and supply chain management, it serves as an essential resource for healthcare professionals, computer scientists, information security professionals, data scientists, policymakers, researchers, and academicians.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309269393 Category : Medical Languages : en Pages : 377
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: Susanne Lundin Publisher: African Sun Media ISBN: 1991260318 Category : Medical Languages : en Pages : 239
Book Description
Medicine Across Borders provides an interdisciplinary space to discuss the issue of substandard and falsified medical products. Scholars from social and medical sciences collaboratively contribute insight to improving safe medicine access. The circulation of medicines and medical products on the informal market is well-known. Stakeholders, including governmental agencies and biotechnic enterprises, invest much effort in designing and implementing macrolevel interventions to limit the spread of such products. Nevertheless, there is a lack of knowledge and understanding of how informal markets function in everyday medicine access and use. This applies to professionals within and beyond academia, state governments, as well as the general public. This book takes an international perspective, examining the issue of substandard and falsified medical products cross nationally. Falsified and poor-quality medicines are prevalent in low- and middle-income countries, but this book also includes research from high-income countries arguing that they too have vulnerabilities, and emphasising the need for vigilance even in well-resourced and well-regulated regimes. Medicine Across Borders: Exploration of Grey Zones provides an interdisciplinary space for a depth and diversity of material that spotlights some contemporary themes hindering access to essential medicines and driving the penetration of substandard and falsified medical products. The authors are drawn from a range of academic disciplines across the social and medical sciences presenting findings from data collected using an eclectic mix of methods and analysis. Surveys, ethnography, narrative case studies, statistical, and thematic analysis are all deployed.
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Author: world health organization
Author: Michael Cheng
Author: OECD
Author: World Health Organization
Author: Jane Huang
Author: Borah, Malaya Dutta
Author: Institute of Medicine
Author: Susanne Lundin
Author: Mergent