Download or read book Cost Contained Regulatory Compliance written by Sandy Weinberg and published by John Wiley & Sons. This book was released on 2011-04-18 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.
Download or read book Business Regulation and Public Policy written by André Nijsen and published by Springer. This book was released on 2008-11-01 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: For years, businesses have complained about the costs of regulatory compliance. On the other hand, society is becoming increasingly aware of the environmental, safety, health, financial, and other risks of business activity. Government oversight seems to be one of the answers to safeguard against these risks. But how can we deregulate and regulate without jeopardizing our public goals or acting as a brake on economic growth? Many instruments are available to assess the effects of laws regulating business, including the regulatory impact assessment (RIA), which contains cost/benefit analysis, cost-effectiveness analysis, risk analysis, and cost assessments. This book argues that public goals will be achieved more effectively if compliance costs of the enterprises are as low as possible. Highlighting examples from a wide spectrum of industries and countries, the authors propose a new kind of RIA, the business impact assessment (BIA), designed to improve both business and public policy decision making.
Download or read book OECD Regulatory Compliance Cost Assessment Guidance written by OECD and published by OECD Publishing. This book was released on 2014-04-28 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidance document provides a practical, technical and user-friendly guidance on measuring and reducing compliance costs of regulation in OECD countries.
Download or read book The Cost of Regulatory Compliance in the United States written by Francesco Trebbi and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: We quantify firms' compliance costs of regulation from 2002 to 2014 in terms of their labor input expenditure to comply with government rules, a primary component of regulatory compliance spending for large portions of the U.S. economy. Detailed establishment-level occupation data, in combination with occupation-specific task information, allow us to recover the share of an establishment's wage bill owing to employees engaged in regulatory compliance. Regulatory costs account on average for 1.34 percent of the total wage bill of a firm, but vary substantially across and within industries, and have increased over time. We investigate the returns to scale in regulatory compliance and find an inverted-U shape, with the percentage regulatory spending peaking for an establishment size of around 500 employees. Finally, we develop an instrumental variable methodology for decoupling the role of regulatory requirements from that of enforcement in driving firms' compliance costs.
Download or read book Impact of Regulatory Compliance Costs on Small Airports written by and published by . This book was released on 2013 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt: "TRB's Airport Cooperative Research Program (ACRP) Report 90: Impact of Regulatory Compliance Costs on Small Airports explores the cumulative costs of complying with regulatory and other federal requirements at small hub and non-hub airports."--Publisher's description.
Download or read book Understanding the Implicit Costs of Regulatory Compliance at a Small Liberal Arts College written by Phillip A. Olt and published by . This book was released on 2018 with total page 143 pages. Available in PDF, EPUB and Kindle. Book excerpt: This single instrumental case study examined the implicit opportunity costs of regulatory compliance at a small liberal arts college (SLAC) in the Midwest. Regulatory compliance was defined broadly, including government sources from all levels as well as institutional accreditation and the National Collegiate Athletic Association (NCAA). I found that regulatory compliance had significant impacts on labor at the SLAC involved in the study. The first theme I found was that regulatory compliance drove many of the staff to perform multiple roles, or, as they described it, to wear many hats. The second theme I identified was that the work of regulatory compliance led those performing the de-centralized duties to become overwhelmed with their responsibilities. The third theme then was that regulatory compliance had altered the institution, as both a strain on its ethos and a driver for positive change. Utilizing the microeconomic concept of implicit cost as a form of opportunity cost, I analyzed the results of this study to discover the substance of the next-best alternative sacrificed for compliance. For individual employees, the implicit cost was self, wherein they would reinvest extra work hours back into their own well-being and relationships. For the institution, there were sacrifices of time with students, what positions were hired, and employee specialization. For society, sacrifices came from common sense, excellence toward achieving policy goals, and innovation toward excellence. I concluded by providing recommendations for policy, practice, and further research.
Download or read book Management of Animal Care and Use Programs in Research Education and Testing written by Robert H. Weichbrod and published by CRC Press. This book was released on 2017-09-07 with total page 917 pages. Available in PDF, EPUB and Kindle. Book excerpt: AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all types of programs involving animal care and use. The new edition has more than doubled the number of chapters in the original volume to present a more comprehensive overview of the current breadth and depth of the field with applicability to an international audience. Readers are provided with the latest information and resource and reference material from authors who are noted experts in their field. The book: - Emphasizes the importance of developing a collaborative culture of care within an animal care and use program and provides information about how behavioral management through animal training can play an integral role in a veterinary health program - Provides a new section on Environment and Housing, containing chapters that focus on management considerations of housing and enrichment delineated by species - Expands coverage of regulatory oversight and compliance, assessment, and assurance issues and processes, including a greater discussion of globalization and harmonizing cultural and regulatory issues - Includes more in-depth treatment throughout the book of critical topics in program management, physical plant, animal health, and husbandry. Biomedical research using animals requires administrators and managers who are knowledgeable and highly skilled. They must adapt to the complexity of rapidly-changing technologies, balance research goals with a thorough understanding of regulatory requirements and guidelines, and know how to work with a multi-generational, multi-cultural workforce. This book is the ideal resource for these professionals. It also serves as an indispensable resource text for certification exams and credentialing boards for a multitude of professional societies Co-publishers on the second edition are: ACLAM (American College of Laboratory Animal Medicine); ECLAM (European College of Laboratory Animal Medicine); IACLAM (International Colleges of Laboratory Animal Medicine); JCLAM (Japanese College of Laboratory Animal Medicine); KCLAM (Korean College of Laboratory Animal Medicine); CALAS (Canadian Association of Laboratory Animal Medicine); LAMA (Laboratory Animal Management Association); and IAT (Institute of Animal Technology).
Download or read book Regulatory Compliance Costs and Other Burdens written by and published by . This book was released on 1996 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Cost of Compliance with Product Standards for Firms in Developing Countries written by Keith E. Maskus and published by . This book was released on 2012 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Standards and technical regulations exist to protect consumer safety or to achieve other goals, such as ensuring the interoperability of telecommunications systems, for example. Standards and technical regulations can, however, raise substantially both start-up and production costs for firms. Maskus, Otsuki, and Wilson develop econometric models to provide the first estimates of the incremental production costs for firms in developing nations in conforming to standards imposed by major importing countries. They use firm-level data generated from 16 developing countries in the World Bank Technical Barriers to Trade (TBT) Survey Database. Their findings indicate that standards do increase short-run production costs by requiring additional inputs of labor and capital. A 1 percent increase in investment to meet compliance costs in importing countries raises variable production costs by between 0.06 and 0.13 percent, a statistically significant increase. The authors also find that the fixed costs of compliance are nontrivial-approximately $425,000 per firm, or about 4.7 percent of value added on average. The results may be interpreted as one indication of the extent to which standards and technical regulations might constitute barriers to trade. While the relative impact on costs of compliance is relatively small, these costs can be decisive factors driving export success for companies. In this context, there is scope for considering that the costs associated with more limited exports to countries with import regulations may not conform to World Trade Organization rules encouraging harmonization of regulations to international standards, for example. Policy solutions then might be sought by identifying the extent to which subsidies or public support programs are needed to offset the cost disadvantage that arises from nonharmonized technical regulations.
Download or read book Government Operations written by U S Government Accountability Office (G and published by BiblioGov. This book was released on 2013-06 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pursuant to a congressional request, GAO reviewed National Institutes of Health grantees' compliance with applicable federal regulations. GAO noted that: (1) researchers and administrators are increasingly concerned about the increase in regulations with which they must comply, but they also acknowledge that the regulations serve important safety goals; (2) researchers believe that certain regulations are inordinately burdensome and costly; (3) regulations that are considered burdensome and costly include those governing environmental protection, protection for human subjects, animal care and use, and conflict-of-interest disclosure; (4) the greatest cost of these regulations is attributed to the staff time devoted to compliance; (5) researchers cannot provide direct compliance cost data or determine how much of their grants they spend on compliance because their information systems cannot differentiate compliance costs from other costs; (6) some costs cannot be avoided even if federal regulations did not exist because they are part of good management and scientific and safety procedures; and (7) eliminating federal regulations may not reduce the compliance burden or cost, since institutions would still need to comply with state and local regulations.
Download or read book Ten Thousand Commandments written by Clyde Wayne Crews and published by Cato Institute. This book was released on 2004 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Cost Principles for Educational Institutions written by United States. Office of Management and Budget and published by . This book was released on 1979 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Government Auditing Standards 2018 Revision written by United States Government Accountability Office and published by Lulu.com. This book was released on 2019-03-24 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: Audits provide essential accountability and transparency over government programs. Given the current challenges facing governments and their programs, the oversight provided through auditing is more critical than ever. Government auditing provides the objective analysis and information needed to make the decisions necessary to help create a better future. The professional standards presented in this 2018 revision of Government Auditing Standards (known as the Yellow Book) provide a framework for performing high-quality audit work with competence, integrity, objectivity, and independence to provide accountability and to help improve government operations and services. These standards, commonly referred to as generally accepted government auditing standards (GAGAS), provide the foundation for government auditors to lead by example in the areas of independence, transparency, accountability, and quality through the audit process. This revision contains major changes from, and supersedes, the 2011 revision.
Download or read book The Regulatory Compliance Matrix Regulation of Financial Services Information and Communication Technology and Generally Related Matters written by Guido Reinke and published by Gold Rush Publishing. This book was released on 2015-07-31 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: This exceptional guidebook is ideal for industry professionals, regulators and scholars in the domain of regulatory governance. The Regulatory Compliance Matrix with more than 2500 entries brings clarity to a domain which is widely considered to be complex, unstructured, and in constant flux. It is a compendious guide to the laws, regulations, standards, and recommendations applicable to compliance programmes. What practitioners find in this book will empower them to save money, man-hours, and consultancy interventions. Inside, the reader will find the following key resources: Regulatory Compliance Matrix: a synopsis of the principal domains of applicable regulation, setting forth legal norms, ancillary standards and guidelines. This Matrix covers the laws and regulations specific to financial services (Part I) and information and communications technology (Part II) at the global and European as well at the UK national and sub-national level. Part III of the Matrix covers generally applicable regulatory domains like corporate governance, consumer protection and employment law, information security, data protection and electronic commerce. Regulatory authorities: a comprehensive listing with descriptions of authorities who define the regulatory agenda. Weblinks are provided for each authority, which enables the reader to access the latest regulatory developments and updates. Overview of the conduct of effective compliance programmes: a pragmatic approach to the entire process, from scoping and prioritisation, conducting risk assessments, defining control activities and reporting requirements; to undertaking effectiveness reviews, documenting findings and making recommendations; to assessing compliance maturity and creating action plans. Non-compliance costs checklist: a detailed list of financial, operational, personal, and regulatory risks. This will assist readers with risk assessment and prioritisation of compliance domains."
Download or read book Business Regulation and Public Policy written by André Nijsen and published by Springer Science & Business Media. This book was released on 2008-12-03 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: For years, businesses have complained about the costs of regulatory compliance. On the other hand, society is becoming increasingly aware of the environmental, safety, health, financial, and other risks of business activity. Government oversight seems to be one of the answers to safeguard against these risks. But how can we deregulate and regulate without jeopardizing our public goals or acting as a brake on economic growth? Many instruments are available to assess the effects of laws regulating business, including the regulatory impact assessment (RIA), which contains cost/benefit analysis, cost-effectiveness analysis, risk analysis, and cost assessments. This book argues that public goals will be achieved more effectively if compliance costs of the enterprises are as low as possible. Highlighting examples from a wide spectrum of industries and countries, the authors propose a new kind of RIA, the business impact assessment (BIA), designed to improve both business and public policy decision making.
Download or read book Model Rules of Professional Conduct written by American Bar Association. House of Delegates and published by American Bar Association. This book was released on 2007 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.
Download or read book Pharmaceutical and Medical Device Compliance Manual written by Ela Bochenek and published by . This book was released on 2019 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: A robust compliance program is essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. The second edition of the Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies develop a compliance program tailored to today's complex enforcement and business environment. Study of this Manual will enable compliance professionals and lawyers to understand the government's expectations of an effective compliance program and ethical business practices, as well as: how the government discovers potential enforcement actions, its approach to pursuing such actions, what behaviors can constitute mitigating factors for a company in the event of a legal violation. Coverage includes new chapters covering:Pharmaceutical industry interactions with patient organizations Compliance 2.0: compliance analytics in the era of big dataThe art and science of health care compliance in the pharmaceutical and medical device industries The Manual will be a great tool for health and life sciences attorneys, compliance officers, and others in the pharmaceutical and medical devices industry
