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Regulated Industries
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Book Synopsis Regulated Industries in a Nutshell by : Richard J. Pierce
Download or read book Regulated Industries in a Nutshell written by Richard J. Pierce and published by West Academic Publishing. This book was released on 1999 with total page 460 pages. Available in PDF, EPUB and Kindle. Book excerpt: This authoritative guide presents the reasons behind industry regulation and the legal basis for it. Text discusses calculating rate base and rate of return, cost allocation, and rate design. Added attention is given to many of the new market-oriented forms of regulation, such as service unbundling, equal access to bottleneck facilities, competitive contracting, managed competition in health care, and incentive regulation.
Book Synopsis Risk and Return for Regulated Industries by : Bente Villadsen
Download or read book Risk and Return for Regulated Industries written by Bente Villadsen and published by Academic Press. This book was released on 2017-04-27 with total page 362 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Handbook of Investigation and Effective CAPA Systems by : Jose (Pepe) Rodriguez-Perez
Download or read book Handbook of Investigation and Effective CAPA Systems written by Jose (Pepe) Rodriguez-Perez and published by Quality Press. This book was released on 2022-02-15 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the ‘usual suspects' to identify other quality issues in order to minimize risks (including safe ones) and reduce costs. Enhancements to this third edition include: A new section linking the investigation and CAPA programs with the overall quality culture of the company Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485 Updated inspectional observations from the U.S. FDA and U.K. MHRA A revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis process New charts and information related to the investigation of human errors; the human factor section includes information about training and competence A new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing results Updated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human error Jose(Pepe) Rodrguez-Perez, PhD, is president of Business Excellence Consulting, Inc., (BEC), a Puerto Rico-based, consulting, training, and remediation firm that focuses on the areas of regulatory compliance, FDA-regulatory training, and risk management. He is a biologist with a doctoral degree in biology from the University of Granada (Spain). Over his career, he has served as an educator, a technical services manager, and as a science advisor to the FDA.
Book Synopsis Quality Risk Management in the FDA-Regulated Industry by : José Rodríguez Pérez
Download or read book Quality Risk Management in the FDA-Regulated Industry written by José Rodríguez Pérez and published by Quality Press. This book was released on 2012-06-12 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Expanding Competition in Regulated Industries by : Michael A. Crew
Download or read book Expanding Competition in Regulated Industries written by Michael A. Crew and published by Springer Science & Business Media. This book was released on 2013-03-09 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Expanding Competition in Regulated Industries reviews the changing regulatory environment, notably incentive regulation and competition in regulated industries. Some of the major changes in electricity, gas, and telephone utilities allow for competition in local service through unbundling. This book is of interest to researchers, utility managers, regulatory commissions, and the Federal Government.
Book Synopsis Statistical Process Control for the FDA-Regulated Industry by : Manuel E. Pena-Rodriguez
Download or read book Statistical Process Control for the FDA-Regulated Industry written by Manuel E. Pena-Rodriguez and published by Quality Press. This book was released on 2013-04-11 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: The focus of this book is to understand and apply the different SPC tools in a company regulated by the Food and Drug Administration (FDA): those that manufacture pharmaceutical products, biologics, medical devices, food, cosmetics, and so on. The book is not intended to provide an intensive course in statistics; instead, it is intended to provide a how-to guide about the application of the diverse array of statistical tools available to analyze and improve the processes in an organization regulated by FDA. This book is aimed at engineers, scientists, analysts, technicians, managers, supervisors, and all other professionals responsible to measure and improve the quality of their processes. Although the examples and case studies presented throughout the book are based on situations found in an organization regulated by FDA, the book can also be used to understand the application of those tools in any type of industry. Readers will obtain a better understanding of some of the statistical tools available to control their processes and be encouraged to study, with a greater level of detail, each of the statistical tools presented throughout the book. The content of this book is the result of the authors almost 20 years of experience in the application of statistics in various industries, and his combined educational background of engineering and law that he has used to provide consulting services to dozens of FDA-regulated organizations.
Book Synopsis The Regulated Industries and the Economy by : Paul W. MacAvoy
Download or read book The Regulated Industries and the Economy written by Paul W. MacAvoy and published by W W Norton & Company Incorporated. This book was released on 1979 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: An authority on regulation who has served on the Council of Economic Advisers calls attention to the explosive growth in regulation since the late 1960s and its effects and examines movements for reform and deregulation
Book Synopsis Cases and Materials on Regulated Industries by : William K. Jones
Download or read book Cases and Materials on Regulated Industries written by William K. Jones and published by . This book was released on 1976 with total page 1340 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :European Institute for Advanced Studies in Management Publisher :Lexington, Mass. : Lexington Books ISBN 13 : Total Pages :312 pages Book Rating :4.F/5 ( download)
Book Synopsis Regulated Industries and Public Enterprise by : European Institute for Advanced Studies in Management
Download or read book Regulated Industries and Public Enterprise written by European Institute for Advanced Studies in Management and published by Lexington, Mass. : Lexington Books. This book was released on 1980 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Antitrust and Regulated Industries by : David C. Hjelmfelt
Download or read book Antitrust and Regulated Industries written by David C. Hjelmfelt and published by John Wiley & Sons. This book was released on 1985 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Mergers in Regulated Industries by : Dennis W. Carlton
Download or read book Mergers in Regulated Industries written by Dennis W. Carlton and published by . This book was released on 2007 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Regulating Artificial Intelligence in Industry by : Damian M. Bielicki
Download or read book Regulating Artificial Intelligence in Industry written by Damian M. Bielicki and published by Routledge. This book was released on 2021-12-24 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: Artificial Intelligence (AI) has augmented human activities and unlocked opportunities for many sectors of the economy. It is used for data management and analysis, decision making, and many other aspects. As with most rapidly advancing technologies, law is often playing a catch up role so the study of how law interacts with AI is more critical now than ever before. This book provides a detailed qualitative exploration into regulatory aspects of AI in industry. Offering a unique focus on current practice and existing trends in a wide range of industries where AI plays an increasingly important role, the work contains legal and technical analysis performed by 15 researchers and practitioners from different institutions around the world to provide an overview of how AI is being used and regulated across a wide range of sectors, including aviation, energy, government, healthcare, legal, maritime, military, music, and others. It addresses the broad range of aspects, including privacy, liability, transparency, justice, and others, from the perspective of different jurisdictions. Including a discussion of the role of AI in industry during the Covid-19 pandemic, the chapters also offer a set of recommendations for optimal regulatory interventions. Therefore, this book will be of interest to academics, students and practitioners interested in technological and regulatory aspects of AI.
Book Synopsis Regulatory Affairs in the Pharmaceutical Industry by : Javed Ali
Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Book Synopsis Change Control for FDA Regulated Industries by : David N. Muchemu
Download or read book Change Control for FDA Regulated Industries written by David N. Muchemu and published by AuthorHouse. This book was released on 2007 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book accomplishes the following: .It addresses requirements for Pharmaceutical, Medical Device, Biologics, and Tissue banking change control .Defines the different phases of the change control life cycle .Establishes the relationship between risk management, cost of doing business and change control .Defines regulatory requirements for change control, including requirements for (510k) submission .Provides tools for risk assesment, and cost/benefit analysis .Helps the reader design a Change control system that meets and exceeds cGMP requirements
Book Synopsis Regulatory Risk: Economic Principles and Applications to Natural Gas Pipelines and Other Industries by : A. Lawrence Kolbe
Download or read book Regulatory Risk: Economic Principles and Applications to Natural Gas Pipelines and Other Industries written by A. Lawrence Kolbe and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is common to assert that utility investors are compensated in the allowed rate of return for the risk of large disallowances, such as arise for investments found imprudent or not `used and useful'. However, this book develops a new theory of asymmetric regulatory risk that shows that infallible estimates of the cost of capital are sure to provide downward-biased estimates of the necessary allowed rates of return in the presence of such regulatory risks. The book uses the new theory of regulatory risk to understand recent developments in the risk of natural gas pipelines and other regulated industries.
Book Synopsis Competition and the Regulation of Utilities by : Michael A. Crew
Download or read book Competition and the Regulation of Utilities written by Michael A. Crew and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: companies to diversify may outweigh the costs of doing so, and that some traditional regulatory concerns may be excessively restrictive. The papers by Hillman, Harris, and Jang and Norsworthy, while all relating to individual industries, have lessons for other regulated industries. Hillman's paper, "Oil Pipeline Rates: A Case for Yardstick Regulation," deals with the important topic of yardstick regulation for oil pipelines. While his application is highly specific, the potential application of yardstick regulation goes beyond oil pipelines. He reviews the evolution in the law regulating oil pipelines. While showing that some progress has been made in introducing economic efficiency considerations into regulation, he provides a careful critique of the operation of existing regulation and suggests an alternative based upon a yardstick approach. His approach seeks to use competitive market prices as the yardstick, with administration of price discrimination limited to dealing with possible "favoritism" to subsidiaries and affiliates. "Telecommunications Services as a Strategic Industry: Implications for United States Public Policy" by Harris and "Productivity Growth and Technical Change in the United States Telecommunications Equipment Manufacturing Industries" by Jang and Norsworthy provide important insights for telecommunications.
Book Synopsis China's Regulatory State by : Roselyn Hsueh Romano
Download or read book China's Regulatory State written by Roselyn Hsueh Romano and published by Cornell University Press. This book was released on 2011-10-15 with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today's China is governed by a new economic model that marks a radical break from the Mao and Deng eras; it departs fundamentally from both the East Asian developmental state and its own Communist past. It has not, however, adopted a liberal economic model. China has retained elements of statist control even though it has liberalized foreign direct investment more than any other developing country in recent years. This mode of global economic integration reveals much about China’s state capacity and development strategy, which is based on retaining government control over critical sectors while meeting commitments made to the World Trade Organization. In China's Regulatory State, Roselyn Hsueh demonstrates that China only appears to be a more liberal state; even as it introduces competition and devolves economic decisionmaking, the state has selectively imposed new regulations at the sectoral level, asserting and even tightening control over industry and market development, to achieve state goals. By investigating in depth how China implemented its economic policies between 1978 and 2010, Hsueh gives the most complete picture yet of China's regulatory state, particularly as it has shaped the telecommunications and textiles industries. Hsueh contends that a logic of strategic value explains how the state, with its different levels of authority and maze of bureaucracies, interacts with new economic stakeholders to enhance its control in certain economic sectors while relinquishing control in others. Sectoral characteristics determine policy specifics although the organization of institutions and boom-bust cycles influence how the state reformulates old rules and creates new ones to maximize benefits and minimize costs after an initial phase of liberalization. This pathbreaking analysis of state goals, government-business relations, and methods of governance across industries in China also considers Japan’s, South Korea’s, and Taiwan’s manifestly different approaches to globalization.
