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Author:
Publisher:
ISBN: 9789213631256
Category : Business enterprises
Languages : en
Pages : 0
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Book Description
"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.
Author:
Publisher:
ISBN: 9789213631256
Category : Business enterprises
Languages : en
Pages : 0
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Book Description
"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.
Author: Lorenza Jachia
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 124
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Book Description
Recent years have been marked by many catastrophic events both natural and man-made. Close interconnections mean that the impact of these crises has been felt throughout the world. Although many tools have been developed to manage risks successfully, there can be no doubt that many of the losses we have recently witnessed could have been prevented, or minimised, in the context of an effective and well-balanced regulatory system. The goal of this publication is to provide insights and recommendations for policymakers on designing regulatory systems that result in an efficient, effective and transparent management of risks. This is a practical book. It introduces a holistic model of a regulatory system, function by function and with real-life examples, which is based on the objective of managing risks effectively.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309096316
Category : Medical
Languages : en
Pages : 481
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Book Description
Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.
Author: Marco Ventoruzzo
Publisher: Oxford University Press, USA
ISBN: 9780198811756
Category : Antitrust law
Languages : en
Pages : 0
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Book Description
This book analyses the European market abuse regime contained in the Market Abuse Regulation (MAR) and related directives and regulations. Written by leading scholars in the field of capital market law from a number of European jurisdictions, the book is divided into two main parts. The first consists of chapters considering relevant issues by topic; whilst the second provides the first article-by-article commentary on the Regulation, with a detailed and technical analysis of its terms. In the first part guidance is arranged by topic and includes aspects not directly addressed by MAR such as enforcement, and the impact of US securities regulation. As well as considering the sources of market abuse regulation in general, this first part also examines its theoretical and economic framework in order to provide better understanding of the Regulation itself.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141
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Book Description
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.
Author: MartÃn Molinuevo
Publisher:
ISBN: 9781306546225
Category : Foreign trade regulation
Languages : en
Pages :
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Book Description
The services sectorranging from telecommunications and banking to business processing and outsourcingis increasingly recognized as part and parcel of any trade strategy, both as a source of export diversification in its own right as well as a key component of a countrys competitiveness. Unlike trade in goods, which is governed by border measures that regulate the entry of foreign merchandise, international trade in services is subject to a wide range of domestic laws and regulations that govern access and operations by both domestic and foreign suppliers. While such regulations are essential where market failures or externalities exist and to ensure non-economic objectives, it is often difficult to differentiate between legitimate policy objectives and protectionist measures that introduce distortions and inefficiency in the market. An unnecessarily restrictive regulatory framework limits the potential of the services sector to develop, and undermines the export opportunities and competitiveness of domestic businesses. This toolkit offers a practical methodology to assess the impact of services regulations: the Regulatory Assessment on Services Trade and Investment (RASTI). The RASTI helps to evaluate whether a countrys regulatory framework is promoting the development of an efficient domestic services market, and offers guidance on how to ensure that services regulation correctly addresses market failures and achieves public policy goals. The authors propose three steps towards a trade-related regulatory assessment: - mapping laws and regulations that affect trade and investment in services, and assessing the regulatory process and institutional arrangements; - wherever possible, providing a quantitative assessment of the impact of regulations on performance and market structure, including prices, quality and access; and - identifying alternative regulations and institutional set-ups that promote an enabling regulatory environment for services trade while achieving the desired policy goals. Performing a regulatory assessment can serve multiple purposes depending on the circumstances and the needs of the evaluators, including bridging information gaps; supporting regulatory reform; supporting trade negotiations; assessing regulatory performance; and promoting better regulatory practices. The Regulatory Assessment Toolkit will be of particular interest to policy makers and government officials from regulatory bodies, experts at development banks and donor agencies, and academics and researchers in the field of economic regulation.
Author: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54
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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:
Publisher: Lulu.com
ISBN: 9291316695
Category : Bank capital
Languages : en
Pages : 294
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Book Description
Author: Ashley C. Brown
Publisher: World Bank Publications
ISBN: 0821365800
Category : Business & Economics
Languages : en
Pages : 422
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Book Description
More than 200 new infrastructure regulators have been created around the world in the last 15 years. They were established to encourage clear and sustainable long-term economic and legal commitments by governments and investors to encourage new investment to benefit existing and new customers. There is now considerable evidence that both investors and consumers-the two groups that were supposed to have benefited from these new regulatory systems-have often been disappointed with their performance. The fundamental premise of this book is that regulatory systems can be successfully reformed only if there are independent, objective and public evaluations of their performance. Just as one goes to a medical doctor for a regular health checkup, it is clear that infrastructure regulation would also benefit from periodic checkups. This book provides a general framework as well as detailed practical guidance on how to perform such "regulatory checkups."
Author: European Commission
Publisher:
ISBN:
Category : Det indre marked
Languages : en
Pages : 124
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Book Description
