Author: Bente Villadsen
Publisher: Academic Press
ISBN: 0128125888
Category : Business & Economics
Languages : en
Pages : 362
Book Description
Risk and Return for Regulated Industries provides a much-needed, comprehensive review of how cost of capital risk arises and can be measured, how the special risks regulated industries face affect fair return, and the challenges that regulated industries are likely to face in the future. Rather than following the trend of broad industry introductions or textbook style reviews of utility finance, it covers the topics of most interest to regulators, regulated companies, regulatory lawyers, and rate-of-return analysts in all countries. Accordingly, the book also includes case studies about various countries and discussions of the lessons international regulatory procedures can offer. - Presents a unified treatment of the regulatory principles and practices used to assess the required return on capital - Addresses current practices before exploring the ways methods play out in practice, including irregularities, shortcomings, and concerns for the future - Focuses on developed economies instead of providing a comprehensive global reviews - Foreword by Stewart C. Myers
Risk and Return for Regulated Industries
Quality Risk Management in the FDA-Regulated Industry
Author: José Rodríguez Pérez
Publisher: Quality Press
ISBN: 0873898346
Category : Business & Economics
Languages : en
Pages : 289
Book Description
Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and effectiveness of the drugs and medical devices. Regulators must decide whether the benefits of a specific product for patients and users outweigh its risk, while recognizing that absolute safety (or zero risk) is not achievable. Every product and every process has an associated risk. Although there are some examples of the use of quality risk management in the FDA-regulated industry today, they are limited and do not represent the full contribution that risk management has to offer. The present FDA focus on risk-based determination is requiring that the regulated industries improve dramatically their understanding and capability of hazard control concepts. In addition, the importance of quality systems has been recognized in the life sciences industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system. The purpose of this book is to offer a systematic and very comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practices or good laboratory practices. The content of this book will provide FDA-regulated manufacturers with a framework within which experience, insight, and judgment are applied systematically to manage the risks associated with their products. Manufacturers in other industries may use it as an informative guidance in developing and maintaining a risk management system and process. The two appendices add even more insight: Appendix A contains general examples of risk management, while Appendix B includes 10 case studies illustrating real examples of the quality risk management process across the medical product arena.
Publisher: Quality Press
ISBN: 0873898346
Category : Business & Economics
Languages : en
Pages : 289
Book Description
Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and effectiveness of the drugs and medical devices. Regulators must decide whether the benefits of a specific product for patients and users outweigh its risk, while recognizing that absolute safety (or zero risk) is not achievable. Every product and every process has an associated risk. Although there are some examples of the use of quality risk management in the FDA-regulated industry today, they are limited and do not represent the full contribution that risk management has to offer. The present FDA focus on risk-based determination is requiring that the regulated industries improve dramatically their understanding and capability of hazard control concepts. In addition, the importance of quality systems has been recognized in the life sciences industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system. The purpose of this book is to offer a systematic and very comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practices or good laboratory practices. The content of this book will provide FDA-regulated manufacturers with a framework within which experience, insight, and judgment are applied systematically to manage the risks associated with their products. Manufacturers in other industries may use it as an informative guidance in developing and maintaining a risk management system and process. The two appendices add even more insight: Appendix A contains general examples of risk management, while Appendix B includes 10 case studies illustrating real examples of the quality risk management process across the medical product arena.
OECD Reviews of Regulatory Reform Risk and Regulatory Policy Improving the Governance of Risk
Author: OECD
Publisher: OECD Publishing
ISBN: 926408293X
Category :
Languages : en
Pages : 251
Book Description
This publication presents recent OECD papers on risk and regulatory policy. They offer measures for developing, or improving, coherent risk governance policies.
Publisher: OECD Publishing
ISBN: 926408293X
Category :
Languages : en
Pages : 251
Book Description
This publication presents recent OECD papers on risk and regulatory policy. They offer measures for developing, or improving, coherent risk governance policies.
Regulating Industrial Internet Through IPR, Data Protection and Competition Law
Author: Rosa Maria Ballardini
Publisher: Kluwer Law International B.V.
ISBN: 9403503416
Category : Law
Languages : en
Pages : 517
Book Description
The digitization of industrial processes has suddenly taken a great leap forward, with burgeoning applications in manufacturing, transportation and numerous other areas. Many stakeholders, however, are uncertain about the opportunities and risks associated with it and what it really means for businesses and national economies. Clarity of legal rules is now a pressing necessity. This book, the first to deal with legal questions related to Industrial Internet, follows a multidisciplinary approach that is instructed by law concerning intellectual property, data protection, competition, contracts and licensing, focusing on business, technology and policy-driven issues. Experts in various relevant fields of science and industry measure the legal tensions created by Industrial Internet in our global economy and propose solutions that are both theoretically valuable and concretely practical, identifying workable business models and practices based on both technical and legal knowledge. Perspectives include the following: regulating Industrial Internet via intellectual property rights (IPR); data ownership versus control over data; artificial intelligence and IPR infringement; patent owning in Industrial Internet; abuse of dominance in Industrial Internet platforms; data collaboration, pooling and hoarding; legal implications of granular versioning technologies; and misuse of information for anticompetitive purposes. The book represents a record of a major collaborative project, held between 2016 and 2019 in Finland, involving a number of universities, technology firms and law firms. As Industrial Internet technologies are already being used in several businesses, it is of paramount importance for the global economy that legal, business and policy-related challenges are promptly analyzed and discussed. This crucially important book not only reveals the legal and policy-related issues that we soon will have to deal with but also facilitates the creation of legislation and policies that promote Industrial-Internet-related technologies and new business opportunities. It will be warmly welcomed by practitioners, patent and other IPR attorneys, innovation economists and companies operating in the Industrial Internet ecosystem, as well as by competition authorities and other policymakers.
Publisher: Kluwer Law International B.V.
ISBN: 9403503416
Category : Law
Languages : en
Pages : 517
Book Description
The digitization of industrial processes has suddenly taken a great leap forward, with burgeoning applications in manufacturing, transportation and numerous other areas. Many stakeholders, however, are uncertain about the opportunities and risks associated with it and what it really means for businesses and national economies. Clarity of legal rules is now a pressing necessity. This book, the first to deal with legal questions related to Industrial Internet, follows a multidisciplinary approach that is instructed by law concerning intellectual property, data protection, competition, contracts and licensing, focusing on business, technology and policy-driven issues. Experts in various relevant fields of science and industry measure the legal tensions created by Industrial Internet in our global economy and propose solutions that are both theoretically valuable and concretely practical, identifying workable business models and practices based on both technical and legal knowledge. Perspectives include the following: regulating Industrial Internet via intellectual property rights (IPR); data ownership versus control over data; artificial intelligence and IPR infringement; patent owning in Industrial Internet; abuse of dominance in Industrial Internet platforms; data collaboration, pooling and hoarding; legal implications of granular versioning technologies; and misuse of information for anticompetitive purposes. The book represents a record of a major collaborative project, held between 2016 and 2019 in Finland, involving a number of universities, technology firms and law firms. As Industrial Internet technologies are already being used in several businesses, it is of paramount importance for the global economy that legal, business and policy-related challenges are promptly analyzed and discussed. This crucially important book not only reveals the legal and policy-related issues that we soon will have to deal with but also facilitates the creation of legislation and policies that promote Industrial-Internet-related technologies and new business opportunities. It will be warmly welcomed by practitioners, patent and other IPR attorneys, innovation economists and companies operating in the Industrial Internet ecosystem, as well as by competition authorities and other policymakers.
Ensuring Safe Food
Author: Institute of Medicine and National Research Council
Publisher: National Academies Press
ISBN: 0309173973
Category : Medical
Languages : en
Pages : 208
Book Description
How safe is our food supply? Each year the media report what appears to be growing concern related to illness caused by the food consumed by Americans. These food borne illnesses are caused by pathogenic microorganisms, pesticide residues, and food additives. Recent actions taken at the federal, state, and local levels in response to the increase in reported incidences of food borne illnesses point to the need to evaluate the food safety system in the United States. This book assesses the effectiveness of the current food safety system and provides recommendations on changes needed to ensure an effective science-based food safety system. Ensuring Safe Food discusses such important issues as: What are the primary hazards associated with the food supply? What gaps exist in the current system for ensuring a safe food supply? What effects do trends in food consumption have on food safety? What is the impact of food preparation and handling practices in the home, in food services, or in production operations on the risk of food borne illnesses? What organizational changes in responsibility or oversight could be made to increase the effectiveness of the food safety system in the United States? Current concerns associated with microbiological, chemical, and physical hazards in the food supply are discussed. The book also considers how changes in technology and food processing might introduce new risks. Recommendations are made on steps for developing a coordinated, unified system for food safety. The book also highlights areas that need additional study. Ensuring Safe Food will be important for policymakers, food trade professionals, food producers, food processors, food researchers, public health professionals, and consumers.
Publisher: National Academies Press
ISBN: 0309173973
Category : Medical
Languages : en
Pages : 208
Book Description
How safe is our food supply? Each year the media report what appears to be growing concern related to illness caused by the food consumed by Americans. These food borne illnesses are caused by pathogenic microorganisms, pesticide residues, and food additives. Recent actions taken at the federal, state, and local levels in response to the increase in reported incidences of food borne illnesses point to the need to evaluate the food safety system in the United States. This book assesses the effectiveness of the current food safety system and provides recommendations on changes needed to ensure an effective science-based food safety system. Ensuring Safe Food discusses such important issues as: What are the primary hazards associated with the food supply? What gaps exist in the current system for ensuring a safe food supply? What effects do trends in food consumption have on food safety? What is the impact of food preparation and handling practices in the home, in food services, or in production operations on the risk of food borne illnesses? What organizational changes in responsibility or oversight could be made to increase the effectiveness of the food safety system in the United States? Current concerns associated with microbiological, chemical, and physical hazards in the food supply are discussed. The book also considers how changes in technology and food processing might introduce new risks. Recommendations are made on steps for developing a coordinated, unified system for food safety. The book also highlights areas that need additional study. Ensuring Safe Food will be important for policymakers, food trade professionals, food producers, food processors, food researchers, public health professionals, and consumers.
Risks of Hazardous Wastes
Author: Paul E. Rosenfeld
Publisher: William Andrew
ISBN: 1437778437
Category : Technology & Engineering
Languages : en
Pages : 473
Book Description
Hazardous waste in the environment is one of the most difficult challenges facing our society. The purpose of this book is to provide a background of the many aspects of hazardous waste, from its sources to its consequences, focusing on the risks posed to human health and the environment. It explains the legislation and regulations surrounding hazardous waste; however, the scope of the book is much broader, discussing agents that are released into the environment that might not be classified as hazardous waste under the regulatory system, but nonetheless pose substantial hazards to human health and the environment. It provides a background of some of the major generators of hazardous wastes, explains the pathways by which humans and wildlife are exposed, and includes discussion of the adverse health effects linked to these pollutants. It provides numerous case studies of hazardous waste mismanagement that have led to disastrous consequences, and highlights the deficiencies in science and regulation that have allowed the public to be subjected to myriad potentially hazardous agents. Finally, it provides a discussion of measures that will need to be taken to control society's hazardous waste problem. This book was designed to appeal to a wide range of audiences, including students, professionals, and general readers interested in the topic. - Provides information about sources of and health risks posed by hazardous waste - Explains the legislation and regulations surrounding hazardous waste - Includes numerous case studies of mismanagement, highlights deficiencies in science and regulation and discusses measures to tackle society's hazardous waste problems
Publisher: William Andrew
ISBN: 1437778437
Category : Technology & Engineering
Languages : en
Pages : 473
Book Description
Hazardous waste in the environment is one of the most difficult challenges facing our society. The purpose of this book is to provide a background of the many aspects of hazardous waste, from its sources to its consequences, focusing on the risks posed to human health and the environment. It explains the legislation and regulations surrounding hazardous waste; however, the scope of the book is much broader, discussing agents that are released into the environment that might not be classified as hazardous waste under the regulatory system, but nonetheless pose substantial hazards to human health and the environment. It provides a background of some of the major generators of hazardous wastes, explains the pathways by which humans and wildlife are exposed, and includes discussion of the adverse health effects linked to these pollutants. It provides numerous case studies of hazardous waste mismanagement that have led to disastrous consequences, and highlights the deficiencies in science and regulation that have allowed the public to be subjected to myriad potentially hazardous agents. Finally, it provides a discussion of measures that will need to be taken to control society's hazardous waste problem. This book was designed to appeal to a wide range of audiences, including students, professionals, and general readers interested in the topic. - Provides information about sources of and health risks posed by hazardous waste - Explains the legislation and regulations surrounding hazardous waste - Includes numerous case studies of mismanagement, highlights deficiencies in science and regulation and discusses measures to tackle society's hazardous waste problems
Economic Regulation and Its Reform
Author: Nancy L. Rose
Publisher: University of Chicago Press
ISBN: 022613816X
Category : Business & Economics
Languages : en
Pages : 619
Book Description
The past thirty years have witnessed a transformation of government economic intervention in broad segments of industry throughout the world. Many industries historically subject to economic price and entry controls have been largely deregulated, including natural gas, trucking, airlines, and commercial banking. However, recent concerns about market power in restructured electricity markets, airline industry instability amid chronic financial stress, and the challenges created by the repeal of the Glass-Steagall Act, which allowed commercial banks to participate in investment banking, have led to calls for renewed market intervention. Economic Regulation and Its Reform collects research by a group of distinguished scholars who explore these and other issues surrounding government economic intervention. Determining the consequences of such intervention requires a careful assessment of the costs and benefits of imperfect regulation. Moreover, government interventions may take a variety of forms, from relatively nonintrusive performance-based regulations to more aggressive antitrust and competition policies and barriers to entry. This volume introduces the key issues surrounding economic regulation, provides an assessment of the economic effects of regulatory reforms over the past three decades, and examines how these insights bear on some of today’s most significant concerns in regulatory policy.
Publisher: University of Chicago Press
ISBN: 022613816X
Category : Business & Economics
Languages : en
Pages : 619
Book Description
The past thirty years have witnessed a transformation of government economic intervention in broad segments of industry throughout the world. Many industries historically subject to economic price and entry controls have been largely deregulated, including natural gas, trucking, airlines, and commercial banking. However, recent concerns about market power in restructured electricity markets, airline industry instability amid chronic financial stress, and the challenges created by the repeal of the Glass-Steagall Act, which allowed commercial banks to participate in investment banking, have led to calls for renewed market intervention. Economic Regulation and Its Reform collects research by a group of distinguished scholars who explore these and other issues surrounding government economic intervention. Determining the consequences of such intervention requires a careful assessment of the costs and benefits of imperfect regulation. Moreover, government interventions may take a variety of forms, from relatively nonintrusive performance-based regulations to more aggressive antitrust and competition policies and barriers to entry. This volume introduces the key issues surrounding economic regulation, provides an assessment of the economic effects of regulatory reforms over the past three decades, and examines how these insights bear on some of today’s most significant concerns in regulatory policy.
Tuberculosis in the Workplace
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309171253
Category : Medical
Languages : en
Pages : 334
Book Description
Before effective treatments were introduced in the 1950s, tuberculosis was a leading cause of death and disability in the United States. Health care workers were at particular risk. Although the occupational risk of tuberculosis has been declining in recent years, this new book from the Institute of Medicine concludes that vigilance in tuberculosis control is still needed in workplaces and communities. Tuberculosis in the Workplace reviews evidence about the effectiveness of control measuresâ€"such as those recommended by the Centers for Disease Control and Preventionâ€"intended to prevent transmission of tuberculosis in health care and other workplaces. It discusses whether proposed regulations from the Occupational Safety and Health Administration would likely increase or sustain compliance with effective control measures and would allow adequate flexibility to adapt measures to the degree of risk facing workers.
Publisher: National Academies Press
ISBN: 0309171253
Category : Medical
Languages : en
Pages : 334
Book Description
Before effective treatments were introduced in the 1950s, tuberculosis was a leading cause of death and disability in the United States. Health care workers were at particular risk. Although the occupational risk of tuberculosis has been declining in recent years, this new book from the Institute of Medicine concludes that vigilance in tuberculosis control is still needed in workplaces and communities. Tuberculosis in the Workplace reviews evidence about the effectiveness of control measuresâ€"such as those recommended by the Centers for Disease Control and Preventionâ€"intended to prevent transmission of tuberculosis in health care and other workplaces. It discusses whether proposed regulations from the Occupational Safety and Health Administration would likely increase or sustain compliance with effective control measures and would allow adequate flexibility to adapt measures to the degree of risk facing workers.
Framework for environmental health risk management
Author: United States. Presidential/Congressional Commission on Risk Assessment and Risk Management
Publisher:
ISBN:
Category : Administrative agencies
Languages : en
Pages : 80
Book Description
Publisher:
ISBN:
Category : Administrative agencies
Languages : en
Pages : 80
Book Description
Risk Management and Regulation
Author: Tobias Adrian
Publisher: International Monetary Fund
ISBN: 1484343913
Category : Business & Economics
Languages : en
Pages : 53
Book Description
The evolution of risk management has resulted from the interplay of financial crises, risk management practices, and regulatory actions. In the 1970s, research lay the intellectual foundations for the risk management practices that were systematically implemented in the 1980s as bond trading revolutionized Wall Street. Quants developed dynamic hedging, Value-at-Risk, and credit risk models based on the insights of financial economics. In parallel, the Basel I framework created a level playing field among banks across countries. Following the 1987 stock market crash, the near failure of Salomon Brothers, and the failure of Drexel Burnham Lambert, in 1996 the Basel Committee on Banking Supervision published the Market Risk Amendment to the Basel I Capital Accord; the amendment went into effect in 1998. It led to a migration of bank risk management practices toward market risk regulations. The framework was further developed in the Basel II Accord, which, however, from the very beginning, was labeled as being procyclical due to the reliance of capital requirements on contemporaneous volatility estimates. Indeed, the failure to measure and manage risk adequately can be viewed as a key contributor to the 2008 global financial crisis. Subsequent innovations in risk management practices have been dominated by regulatory innovations, including capital and liquidity stress testing, macroprudential surcharges, resolution regimes, and countercyclical capital requirements.
Publisher: International Monetary Fund
ISBN: 1484343913
Category : Business & Economics
Languages : en
Pages : 53
Book Description
The evolution of risk management has resulted from the interplay of financial crises, risk management practices, and regulatory actions. In the 1970s, research lay the intellectual foundations for the risk management practices that were systematically implemented in the 1980s as bond trading revolutionized Wall Street. Quants developed dynamic hedging, Value-at-Risk, and credit risk models based on the insights of financial economics. In parallel, the Basel I framework created a level playing field among banks across countries. Following the 1987 stock market crash, the near failure of Salomon Brothers, and the failure of Drexel Burnham Lambert, in 1996 the Basel Committee on Banking Supervision published the Market Risk Amendment to the Basel I Capital Accord; the amendment went into effect in 1998. It led to a migration of bank risk management practices toward market risk regulations. The framework was further developed in the Basel II Accord, which, however, from the very beginning, was labeled as being procyclical due to the reliance of capital requirements on contemporaneous volatility estimates. Indeed, the failure to measure and manage risk adequately can be viewed as a key contributor to the 2008 global financial crisis. Subsequent innovations in risk management practices have been dominated by regulatory innovations, including capital and liquidity stress testing, macroprudential surcharges, resolution regimes, and countercyclical capital requirements.