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Cost-Contained Regulatory Compliance

Cost-Contained Regulatory Compliance
Author: Sandy Weinberg
Publisher: John Wiley & Sons
Total Pages: 295
Release: 2011-04-18
Genre: Medical
ISBN: 111800227X

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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.


Business Regulation and Public Policy

Business Regulation and Public Policy
Author: André Nijsen
Publisher: Springer
Total Pages: 360
Release: 2008-12-18
Genre: Law
ISBN: 9780387776774

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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.


The Cost of Regulatory Compliance in the United States

The Cost of Regulatory Compliance in the United States
Author: Francesco Trebbi
Publisher:
Total Pages: 0
Release: 2022
Genre:
ISBN:

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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.


Impact of Regulatory Compliance Costs on Small Airports

Impact of Regulatory Compliance Costs on Small Airports
Author:
Publisher:
Total Pages: 96
Release: 2013
Genre: Airports
ISBN:

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"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.


Business Regulation and Public Policy

Business Regulation and Public Policy
Author: André Nijsen
Publisher: Springer Science & Business Media
Total Pages: 361
Release: 2008-12-03
Genre: Law
ISBN: 0387776788

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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.


Valuing Health for Regulatory Cost-Effectiveness Analysis

Valuing Health for Regulatory Cost-Effectiveness Analysis
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 382
Release: 2006-04-28
Genre: Medical
ISBN: 0309164842

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Promoting human health and safety by reducing exposures to risks and harms through regulatory interventions is among the most important responsibilities of the government. Such efforts encompass a wide array of activities in many different contexts: improving air and water quality; safeguarding the food supply; reducing the risk of injury on the job, in transportation, and from consumer products; and minimizing exposure to toxic chemicals. Estimating the magnitude of the expected health and longevity benefits and reductions in mortality, morbidity, and injury risks helps policy makers decide whether particular interventions merit the expected costs associated with achieving these benefits and inform their choices among alternative strategies. Valuing Health for Regulatory Cost-Effectiveness Analysis provides useful recommendations for how to measure health-related quality of- life impacts for diverse public health, safety, and environmental regulations. Public decision makers, regulatory analysts, scholars, and students in the field will find this an essential review text. It will become a standard reference for all government agencies and those consultants and contractors who support the work of regulatory programs.


Management of Animal Care and Use Programs in Research, Education, and Testing

Management of Animal Care and Use Programs in Research, Education, and Testing
Author: Robert H. Weichbrod
Publisher: CRC Press
Total Pages: 917
Release: 2017-09-07
Genre: Medical
ISBN: 1498748457

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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).


OECD Regulatory Compliance Cost Assessment Guidance

OECD Regulatory Compliance Cost Assessment Guidance
Author: OECD
Publisher: OECD Publishing
Total Pages: 78
Release: 2014-04-28
Genre:
ISBN: 9264209654

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This guidance document provides a practical, technical and user-friendly guidance on measuring and reducing compliance costs of regulation in OECD countries.


The Regulatory Compliance Matrix: Regulation of Financial Services, Information and Communication Technology, and Generally Related Matters

The Regulatory Compliance Matrix: Regulation of Financial Services, Information and Communication Technology, and Generally Related Matters
Author: Guido Reinke
Publisher: Gold Rush Publishing
Total Pages: 298
Release: 2015-07-31
Genre: Business & Economics
ISBN: 9781908585059

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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."


Cost Principles for Educational Institutions

Cost Principles for Educational Institutions
Author: United States. Office of Management and Budget
Publisher:
Total Pages: 72
Release: 1979
Genre: Federal aid to higher education
ISBN:

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