Achieving Regulatory Excellence

Achieving Regulatory Excellence
Author: Cary Coglianese
Publisher: Brookings Institution Press
Total Pages: 360
Release: 2016-12-20
Genre: Political Science
ISBN: 0815728433

Whether striving to protect citizens from financial risks, climate change, inadequate health care, or the uncertainties of the emerging “sharing” economy, regulators must routinely make difficult judgment calls in an effort to meet the conflicting demands that society places on them. Operating within a political climate of competing demands, regulators need a lodestar to help them define and evaluate success. Achieving Regulatory Excellence provides that direction by offering new insights from law, public administration, political science, sociology, and policy sciences on what regulators need to do to improve their performance. Achieving Regulatory Excellence offers guidance from leading international experts about how regulators can set appropriate priorities and make sound, evidence-based decisions through processes that are transparent and participatory. With increasing demands for smarter but leaner government, the need for sound regulatory capacity—for regulatory excellence—has never been stronger.

Responsive Regulation

Responsive Regulation
Author: Ian Ayres
Publisher: Oxford University Press
Total Pages: 216
Release: 1995-02-16
Genre: Law
ISBN: 0199879958

This book transcends current debate on government regulation by lucidly outlining how regulations can be a fruitful combination of persuasion and sanctions. The regulation of business by the United States government is often ineffective despite being more adversarial in tone than in other nations. The authors draw on both empirical studies of regulation from around the world and modern game theory to illustrate innovative solutions to this problem. Their ideas include an argument for the empowerment of private and public interest groups in the regulatory process and a provocative discussion of how the government can support and encourage industry self-regulation.

Fundamentals of Regulatory Design

Fundamentals of Regulatory Design
Author: Malcolm Sparrow
Publisher:
Total Pages: 144
Release: 2020-07-30
Genre:
ISBN:

Subject: The modern regulatory world is crowded with ideas about different regulatory approaches including, among others: performance-based regulation, self-regulation, light-touch regulation, right-touch regulation, safety management systems, 3rd party regulation, co-regulation, prescriptive regulation, risk-based regulation, a harm-reduction approach, problem-solving, and responsive regulation. Are these various terms merely rhetorical, or aspirational? Do they signal the political preferences of the times? Which of them actually affect operations? Professional regulators--along with everyone else in the risk-control business--face a complex array of choices when they design (or redesign) their strategies and structures, programs, work-flows, relationships, and day-to-day operations. What regulators choose to do, and how they choose to do it, greatly affects their effectiveness, as well as the quality of life in a democracy. This book tackles five major design issues that affect all regulators (and can be applied by anyone else in the risk-control business). It demystifies the various labels and vogue prescriptions for regulatory conduct, clarifies the options, and generates a range of distinct ideas about what it might mean to be a "risk-based regulator." Audience: This book is designed primarily for regulatory practitioners, but will be relevant for other professionals whose roles include risk-management and harm-reduction. In the public sector, this includes law-enforcement and public-safety organizations, as well as security and intelligence agencies. In the private sector it includes compliance managers, safety officers and risk-managers. In the not-for-profit sector this includes any organization that takes on, or contributes to, harm-reduction missions. Author: Professor Malcolm K. Sparrow, of Harvard's Kennedy School of Government, has been working with senior officials in regulatory and enforcement agencies for over 30 years. Prior to joining Harvard's faculty in 1988, he served ten years with the British Police Service, rising to the rank of Detective Chief Inspector. He has authored eight other books, including The Regulatory Craft (Brookings, 2000) and The Character of Harms (Cambridge University Press, 2008). He chairs Harvard's Executive Program: "Strategic Management of Regulatory & Enforcement Agencies." Contents: This book is designed, in the context of a pandemic, to substitute for five core lectures/discussions that would normally be delivered face-to-face in executive-level courses and workshops. Professor Sparrow offers these lectures here in a comfortably accessible and conversational style. Each chapter describes a different dimension of choice, inviting readers to assess their own organization's history and habits as a precursor to figuring out whether, looking forward, some adjustment is warranted or desirable. Each chapter contains a collection of "Frequently Asked Questions" reflecting practitioners' common queries about the concepts presented, and ends with a "Diagnostic Exercise" (a set of probing questions) that readers can use, perhaps with colleagues in a book-group, to apply the analysis in their own setting. Online Teaching: Individual chapters can be assigned as "asynchronous study assignments" for courses on regulatory practice. Students, feeling "all screened out," may appreciate the availability of the paperback edition.

Regulatory Compliance Fundamentals

Regulatory Compliance Fundamentals
Author: M.L. Humphrey
Publisher: M.L. Humphrey
Total Pages: 68
Release: 2020-01-02
Genre: Business & Economics
ISBN:

We live in a regulated world. And for someone whose role is in regulatory compliance or regulatory enforcement knowledge is often gained on an ad hoc basis through trial and error, via on the job training, or through conversations with others in a similar role. In Regulatory Compliance Fundamentals M.L. Humphrey has taken twenty years of experience as a regulator and a consultant in the financial services industry and boiled it down to the basic fundamental principles every individual in regulatory compliance should know, and presented that information in a straight-forward, easy to understand manner. If your role is in regulatory compliance, no matter how long you've been at this, this book is for you. keywords: regulatory compliance, financial services regulation, AML, OFAC, broker-dealer, how to comply with regulatory requirements, compliance program, reputational risk, business ethics

Strategies for Compliance

Strategies for Compliance
Author: Alan Brener
Publisher: Routledge
Total Pages: 299
Release: 2020-12-20
Genre: Business & Economics
ISBN: 1000320243

Compliance is a fundamental control function within regulated industries globally. This book provides an expert introduction to corporate compliance using cases, examples and insights from the financial services sector and beyond. The author, an experienced compliance practitioner and academic, highlights compliance challenges, using examples such as Wells Fargo, whistleblowing in the financial services and the mis-selling of payment protection insurance in the UK banking sector. The book explores strategies for creating compliant cultures and fostering regulatory trust, whilst practical guidance is provided on anticipating regulatory changes. Addressing organisational obstruction and delay, the author presents a series of valuable tools and techniques for real-world practice. An essential professional development resource for board directors, compliance officers and other senior managers, the book also provides a unique learning and development resource for students of corporate compliance globally.

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

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."

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Author: John Geigert
Publisher: Springer
Total Pages: 446
Release: 2019-05-08
Genre: Medical
ISBN: 3030137546

Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.

Research Regulatory Compliance

Research Regulatory Compliance
Author: Mark A. Suckow
Publisher: Academic Press
Total Pages: 345
Release: 2015-06-14
Genre: Medical
ISBN: 0124200656

Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users for the deluge of regulatory and compliance issues they will face while conducting their scientific programs. The book is edited and authored by known leaders in the field of compliance and regulations, and contains extensive research on the topics. It represents the new standard for information in every laboratory. - Provides a "one-stop" , go-to resource for the many regulatory and compliance issues that affect laboratory study and research models - Extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and also a great asset for faculty or new researchers coming in to the laboratory environment - Focuses on United States regulations, covering both animal models and human subjects - Written and edited by known leaders in the field of regulatory compliance who bring many years of collective experience to the book

The Cambridge Handbook of Compliance

The Cambridge Handbook of Compliance
Author: Benjamin van Rooij
Publisher: Cambridge University Press
Total Pages: 1559
Release: 2021-05-20
Genre: Law
ISBN: 1108754139

Compliance has become key to our contemporary markets, societies, and modes of governance across a variety of public and private domains. While this has stimulated a rich body of empirical and practical expertise on compliance, thus far, there has been no comprehensive understanding of what compliance is or how it influences various fields and sectors. The academic knowledge of compliance has remained siloed along different disciplinary domains, regulatory and legal spheres, and mechanisms and interventions. This handbook bridges these divides to provide the first one-stop overview of what compliance is, how we can best study it, and the core mechanisms that shape it. Written by leading experts, chapters offer perspectives from across law, regulatory studies, management science, criminology, economics, sociology, and psychology. This volume is the definitive and comprehensive account of compliance.