Download or read book Policy paper on traceability of medical products written by and published by World Health Organization. This book was released on 2021-03-19 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Policy Paper on Traceability of Medical Products written by world health organization and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book OECD Health Policy Studies Securing Medical Supply Chains in a Post Pandemic World written by OECD and published by OECD Publishing. This book was released on 2024-02-23 with total page 145 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Medicine Across Borders Exploration of Grey Zones written by Susanne Lundin and published by African Sun Media. This book was released on 2023-11-15 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Prospects of Blockchain Technology for Accelerating Scientific Advancement in Healthcare written by Borah, Malaya Dutta and published by IGI Global. This book was released on 2021-12-13 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book People centred approach to addressing antimicrobial resistance in human health written by World Health Organization and published by World Health Organization. This book was released on 2023-10-19 with total page 63 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document outlines the concept and content of the WHO people-centred approach to addressing antimicrobial resistance (AMR) in the human health sector. The proposed approach recognizes and aims to address the challenges and health system barriers people face when accessing health services to prevent, diagnose and treat (drug-resistant) infections. It puts people and their needs at the centre of the AMR response and guides policy-makers in taking programmatic and comprehensive actions to mitigate AMR in line with a proposed package of core interventions. These interventions are based on a review of four pillars and two foundational steps that are critical to overcome barriers faced by people and health systems in addressing AMR. The four pillars are: (1) prevention of infections; (2) access to essential health services; (3) timely, accurate diagnosis; and (4) appropriate, quality-assured treatment. The pillars are supported by the two foundational steps: effective governance, awareness and education; and strategic information through surveillance and research. Building and adding on to the objectives of the Global action plan on AMR, the 13 core interventions and accompanying priority actions are designed to address AMR in a programmatic manner that puts people, their needs and equitable access to health services at the centre of the AMR response in the community, in primary care, secondary and tertiary care, and at national and/or subnational level. The development of the people-centred core package of AMR interventions was based on a review of the evidence and multidisciplinary expert opinion, complemented with feedback from a global online consultation and WHO’s strategic and technical advisory group on antimicrobial resistance. As countries develop or revise their national action plans (NAPs) on AMR, the people-centred core package of interventions can support the design and prioritization of actions in the human health sector at the different levels of implementation and integrated with broader health system strengthening and pandemic preparedness and response plans.
Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Countering the Problem of Falsified and Substandard Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-20 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Access to NCD medicines emergent issues during the COVID 19 pandemic and key structural factors written by World Health Organization and published by World Health Organization. This book was released on 2023-03-22 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt: The coronavirus disease (COVID-19) pandemic exacerbated pre-existing inequalities in the treatment and care of non-communicable diseases (NCD). The report examines the effect of the COVID-19 pandemic on access to NCD medicines, and the policies and strategies implemented by countries and health systems to anticipate and mitigate stresses across NCD medicine supply chains. The full range of upstream and downstream impacts are investigated, including: manufacturing; procurement, importation and last mile delivery; patient-level effects through affordability and availability; and the effects on NCD medicine availability by category of disease. The report culminates in recommended actions and interventions for key stakeholders in the NCD pharmaceutical supply chain, including governments, regulatory authorities, manufacturers and the private sector; as well as directions for future research for improving access and supply chain access resilience.
Download or read book Software and Systems Traceability written by Jane Huang and published by Springer Science & Business Media. This book was released on 2012-02-02 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Food Traceability written by Jennifer McEntire and published by Springer. This book was released on 2019-05-11 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a picture of food traceability for all aspects of the food system, recognizing the unique differences, challenges, and “states of the industry” in different types of food products, as well as the different pressures and opportunities at different points in the supply chain and the research that has already been done. It also provides some historical context, along with the types of solutions available to the food industry, and the benefits associated with better recordkeeping that go beyond the public good and impact the bottom line. Whenever a food related outbreak occurs, traceability is called into question. When lives are at stake, it is critical that the root of the problem is quickly identified to prevent further illness. Once the problem is found, it’s just as important to contain it quickly. Too often, recalls expand because implicated product is not readily accounted for. Mention of traceability stirs fear for many in the food industry for several reasons: within a company, it’s not clear if responsibility for traceability lies with food safety professionals involved in recalls, supply chain professionals who understand product movement, IT professionals who build and maintain the recordkeeping systems, or regulatory professionals who need to respond to government requests for information. There is also a sense that traceability is someone else’s problem. Few firms admit that they are the weak link and instead tout how quickly they can perform mock recalls. But traceability is about more than just recalls. It is about the connectivity of the supply chain as a product and its constituents travel from the farm to the consumer. Because it is a systems issue, there is a sense that the investment by a single firm will be meaningless if supply chain partners don’t have comparable abilities. This book will address both these surrounding issues and solutions.
Download or read book Healthcare Reference Book written by Mergent and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Strategy is Digital written by Carlos Cordon and published by Springer. This book was released on 2016-06-01 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents strategies and practices to allow everyday companies to cope with the fundamentally changing landscape of business models and to take advantage of the huge business opportunities arising from the advent of big data. It develops several case studies from companies in traditional industries like LEGO, Yamato and Mediq, but also examines small start-ups like Space Tango, which is partnering with major multinationals to develop new business models using big data. The book argues that businesses need to adapt and embark on their big data journey, helps them take the first step, and guides them along their way. It presents successful examples and deducts essential takeaway lessons from them, equipping executives to capitalize on big data and enabling them to make intelligent decisions in the big data transformation, giving their companies an essential competitive edge.
Download or read book Evergreening Patent Exclusivity in Pharmaceutical Products written by Frantzeska Papadopoulou and published by Bloomsbury Publishing. This book was released on 2021-09-23 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyses 4 central pieces of EU pharmaceutical regulation: the Orphan Drugs Regulation, the Paediatric Regulation, the Supplementary Protection Certificate Regulation, and the ATMP (Advanced Therapy Medicinal Products) Regulation. These four regulatory instruments constitute focal points in the pharmaceutical industry's approach to modern business and legal strategy. Their central role is justified by the way these regulatory instruments interact with each other and with the patent system, and by the considerable impact they (as a whole) have for the evergreening of exclusive rights on pharmaceutical products. The book guides the reader through the latest case law and legislative developments and discusses how these influence strategic legal and business choices in the pharmaceutical industry. It brings to the forefront the often-overlooked significance of the legislative architecture of the EU pharmaceutical regulatory framework, and evaluates its results through the lens of the efficiency test. The book is an important resource for academics and practitioners interested in updated case law and an in-depth analysis of these four regulations. It is also important for those interested in legislative studies, evaluation of legislation and a critical approach to legislative architecture.
Download or read book Medical Devices written by Christa Altenstetter and published by Routledge. This book was released on 2017-09-08 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices are the bread and butter from which health care and clinical research are derived. Such devices are used for patient care, genetic testing, clinical trials, and experimental clinical investigations. Without medical devices, there is no clinical research or patient care. Without life-adjusting devices, there are no medical procedures or surgery. Without life-saving and life-maintaining devices, there is no improvement in well-being and quality of life. Without innovative medical devices and experimentation, there can be no medical progress or patient safety. Medical devices and medical technology are used to create or support many different products and medical-surgical procedures. This volume on the regulation of medical devices in the European Union, with a focus on France, tackles a topic of interdisciplinary interest and significance for policymakers in countries around the globe. The EU regulatory regime is one of three global regional regimes, and medical products manufactured in EU countries are sold worldwide. As countries confront an aging population on a global scale, with associated increases in chronic diseases, physical handicaps, and multi-morbidity, there will inevitably be an increase in the demand for health services and, concomitantly, the use of medical devices in medical and surgical procedures. This will be the case regardless of whether services are delivered in hospitals, doctors' offices, or at home. The associated risks of a particular device will be the same whatever the country of origin for the device, or where the need occurs. Revolutionary medical advances increase diagnostic capabilities, but they increase the potential of harm and risks to patients. Medical technologies and devices are used ethically most of the time; yet they have the potential for unethical use when scientific medicine is elevated over human life and death. Assumptions that are taken for granted can be dangerous to a patient's health. That is why our understanding of appropriate and effective regulation of medical devices is significant to all people on all continents.
Download or read book Handbook of Systems Engineering and Risk Management in Control Systems Communication Space Technology Missile Security and Defense Operations written by Anna M. Doro-on and published by CRC Press. This book was released on 2022-09-27 with total page 817 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides multifaceted components and full practical perspectives of systems engineering and risk management in security and defense operations with a focus on infrastructure and manpower control systems, missile design, space technology, satellites, intercontinental ballistic missiles, and space security. While there are many existing selections of systems engineering and risk management textbooks, there is no existing work that connects systems engineering and risk management concepts to solidify its usability in the entire security and defense actions. With this book Dr. Anna M. Doro-on rectifies the current imbalance. She provides a comprehensive overview of systems engineering and risk management before moving to deeper practical engineering principles integrated with newly developed concepts and examples based on industry and government methodologies. The chapters also cover related points including design principles for defeating and deactivating improvised explosive devices and land mines and security measures against kinds of threats. The book is designed for systems engineers in practice, political risk professionals, managers, policy makers, engineers in other engineering fields, scientists, decision makers in industry and government and to serve as a reference work in systems engineering and risk management courses with focus on security and defense operations.
