Author : Sandy Weinberg
Publisher : John Wiley & Sons
Page : 295 pages
File Size : 13,55 MB
Release : 2011-04-18
Category : Medical
ISBN : 111800227X
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.
Author : André Nijsen
Publisher : Springer
Page : 0 pages
File Size : 24,94 MB
Release : 2008-11-01
Category : Law
ISBN : 9780387569291
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.
Author : OECD
Publisher : OECD Publishing
Page : 78 pages
File Size : 38,53 MB
Release : 2014-04-28
Category :
ISBN : 9264209654
This guidance document provides a practical, technical and user-friendly guidance on measuring and reducing compliance costs of regulation in OECD countries.
Author : Francesco Trebbi
Publisher :
Page : 0 pages
File Size : 12,7 MB
Release : 2022
Category :
ISBN :
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.
Author : Keith Eugene Maskus
Publisher : World Bank Publications
Page : 35 pages
File Size : 38,23 MB
Release : 2005
Category : Administrative and Regulatory Law
ISBN :
Abstract: 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.
Author :
Publisher :
Page : 96 pages
File Size : 37,51 MB
Release : 2013
Category : Airports
ISBN :
"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.
Author : André Nijsen
Publisher : Springer Science & Business Media
Page : 361 pages
File Size : 44,53 MB
Release : 2008-12-03
Category : Law
ISBN : 0387776788
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.
Author : Phillip A. Olt
Publisher :
Page : 143 pages
File Size : 10,78 MB
Release : 2018
Category : Education, Higher
ISBN : 9780438121683
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.
Author : Robert H. Weichbrod
Publisher : CRC Press
Page : 917 pages
File Size : 42,36 MB
Release : 2017-09-07
Category : Medical
ISBN : 1498748457
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).
Author :
Publisher :
Page : 54 pages
File Size : 39,7 MB
Release : 1996
Category : Business enterprises
ISBN :
