Download or read book Training Guide on Regulatory Frameworks and Market Surveillance written by and published by . This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This guide is a practical tool to help trainers in the preparation, delivery and follow-up to a set of training workshops. Both this guide and the workshop materials have been prepared by the UNECE Secretariat, in collaboration with training and subject-matter experts. The subject of the trainings is that this guidebook supports concerns how to build risk-based regulatory frameworks"--Page 1.
Download or read book WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices written by World Health Organization and published by . This book was released on 2017-05-09 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.
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 International Convergence of Capital Measurement and Capital Standards written by and published by Lulu.com. This book was released on 2004 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Ensuring Quality to Gain Access to Global Markets written by Martin Kellermann and published by World Bank Publications. This book was released on 2019-04-09 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a modern world with rapidly growing international trade, countries compete less based on the availability of natural resources, geographical advantages, and lower labor costs and more on factors related to firms' ability to enter and compete in new markets. One such factor is the ability to demonstrate the quality and safety of goods and services expected by consumers and confirm compliance with international standards. To assure such compliance, a sound quality infrastructure (QI) ecosystem is essential. Jointly developed by the World Bank Group and the National Metrology Institute of Germany, this guide is designed to help development partners and governments analyze a country's quality infrastructure ecosystems and provide recommendations to design and implement reforms and enhance the capacity of their QI institutions.
Download or read book Powering the Digital Economy Opportunities and Risks of Artificial Intelligence in Finance written by El Bachir Boukherouaa and published by International Monetary Fund. This book was released on 2021-10-22 with total page 35 pages. Available in PDF, EPUB and Kindle. Book excerpt: This paper discusses the impact of the rapid adoption of artificial intelligence (AI) and machine learning (ML) in the financial sector. It highlights the benefits these technologies bring in terms of financial deepening and efficiency, while raising concerns about its potential in widening the digital divide between advanced and developing economies. The paper advances the discussion on the impact of this technology by distilling and categorizing the unique risks that it could pose to the integrity and stability of the financial system, policy challenges, and potential regulatory approaches. The evolving nature of this technology and its application in finance means that the full extent of its strengths and weaknesses is yet to be fully understood. Given the risk of unexpected pitfalls, countries will need to strengthen prudential oversight.
Download or read book Medical Devices and the Public s Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Download or read book Guide to the Implementation of Directives Based on the New Approach and the Global Approach written by European Commission and published by . This book was released on 2000 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book NCUA Examiner s Guide written by United States. National Credit Union Administration and published by . This book was released on 1997 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book WHO Global Benchmarking Tool GBT for evaluation of national regulatory systems of medical products revision VI written by and published by World Health Organization. This book was released on 2021-05-10 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Download or read book Improving Healthcare Quality in Europe Characteristics Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.
Download or read book Regulatory Policy and Governance Supporting Economic Growth and Serving the Public Interest written by OECD and published by OECD Publishing. This book was released on 2011-10-25 with total page 155 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report encourages governments to “think big” about the relevance of regulatory policy and assesses the recent efforts of OECD countries to develop and deepen regulatory policy and governance.
Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
Download or read book NASDAQ Glossary The NASDAQ Investor s Guide written by Chetan Singh and published by Chetan Singh. This book was released on 2023-10-11 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt: Are you an aspiring investor looking to navigate the complex world of NASDAQ with confidence? "NASDAQ Glossary: The NASDAQ Investor's Guide" is your essential companion to understanding and mastering the intricacies of this dynamic stock exchange. Inside the pages of this comprehensive guide, you'll find a treasure trove of information that demystifies the NASDAQ market. Whether you're a novice investor or a seasoned trader, this book serves as your indispensable reference, equipping you with the knowledge and terminology required to make informed decisions. Whether you aim to build a robust investment portfolio or simply seek to broaden your financial knowledge, "NASDAQ Terms: The NASDAQ Investor's Guide" is an indispensable resource. By the time you've turned the final page, you'll be equipped with the skills and confidence to navigate the NASDAQ market effectively and make informed investment decisions. Unlock the potential of NASDAQ with this invaluable guide, and embark on your journey towards financial success. Get ready to invest smarter, trade wiser, and secure your financial future with NASDAQ Glossary Book.
Download or read book International Regulatory Co operation written by OECD and published by Org. for Economic Cooperation & Development. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Borders are becoming increasingly porous, with growing flows of goods, services, people and capital. Governments, more than ever, need to co-ordinate their efforts to develop global standards to address climate change, as well as crises related to finance, health, environment and migration; secure peace; and ensure sustainable economic prosperity and social inclusion. International organisations play a key role in fostering multilateral action and addressing the fragmentation that may undermine effective domestic action. To shed greater light on international standard setting, this unique report collects, compares and assesses the practices of 50 international organisations on their governance arrangements, operational modalities, use of quality management disciplines and co-operation efforts. It analyses different types of organisations - inter-governmental, supra-national, trans-governmental and private - and identifies avenues for making their action more effective, inclusive and relevant. [Resumen de editor]
