Regulatory Compliance Fundamentals

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

A guide to the basics of AML regulation with a focus on customer identification and suspicious activity reporting and monitoring.

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.

Bank Regulation, Risk Management, and Compliance is a concise yet comprehensive treatment of the primary areas of US banking regulation – micro-prudential, macroprudential, financial consumer protection, and AML/CFT regulation – and their associated risk management and compliance systems. The book’s focus is the US, but its prolific use of standards published by the Basel Committee on Banking Supervision and frequent comparisons with UK and EU versions of US regulation offer a broad perspective on global bank regulation and expectations for internal governance. The book establishes a conceptual framework that helps readers to understand bank regulators’ expectations for the risk management and compliance functions. Informed by the author’s experience at a major credit rating agency in helping to design and implement a ratings compliance system, it explains how the banking business model, through credit extension and credit intermediation, creates the principal risks that regulation is designed to mitigate: credit, interest rate, market, and operational risk, and, more broadly, systemic risk. The book covers, in a single volume, the four areas of bank regulation and supervision and the associated regulatory expectations and firms’ governance systems. Readers desiring to study the subject in a unified manner have needed to separately consult specialized treatments of their areas of interest, resulting in a fragmented grasp of the subject matter. Banking regulation has a cohesive unity due in large part to national authorities’ agreement to follow global standards and to the homogenizing effects of the integrated global financial markets. The book is designed for legal, risk, and compliance banking professionals; students in law, business, and other finance-related graduate programs; and finance professionals generally who want a reference book on bank regulation, risk management, and compliance. It can serve both as a primer for entry-level finance professionals and as a reference guide for seasoned risk and compliance officials, senior management, and regulators and other policymakers. Although the book’s focus is bank regulation, its coverage of corporate governance, risk management, compliance, and management of conflicts of interest in financial institutions has broad application in other financial services sectors. Chapter 6 of this book is freely available as a downloadable Open Access PDF at http://www.taylorfrancis.com under a Creative Commons Attribution-Non Commercial-No Derivatives (CC-BY-NC-ND) 4.0 license.

The IT Regulatory and Standards Compliance Handbook provides comprehensive methodology, enabling the staff charged with an IT security audit to create a sound framework, allowing them to meet the challenges of compliance in a way that aligns with both business and technical needs. This "roadmap" provides a way of interpreting complex, often confusing, compliance requirements within the larger scope of an organization's overall needs. The ulitmate guide to making an effective security policy and controls that enable monitoring and testing against them The most comprehensive IT compliance template available, giving detailed information on testing all your IT security, policy and governance requirements A guide to meeting the minimum standard, whether you are planning to meet ISO 27001, PCI-DSS, HIPPA, FISCAM, COBIT or any other IT compliance requirement Both technical staff responsible for securing and auditing information systems and auditors who desire to demonstrate their technical expertise will gain the knowledge, skills and abilities to apply basic risk analysis techniques and to conduct a technical audit of essential information systems from this book This technically based, practical guide to information systems audit and assessment will show how the process can be used to meet myriad compliance issues

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.

The Regulatory Craft tackles one of the most pressing public policy issues of our time—the reform of regulatory and enforcement practice. Malcolm K. Sparrow shows how the vogue prescriptions for reform (centered on concepts of customer service and process improvement) fail to take account of the distinctive character of regulatory responsibilities—which involve the delivery of obligations rather than just services.In order to construct more balanced prescriptions for reform, Sparrow invites us to reconsider the central purpose of social regulation—the abatement or control of risks to society. He recounts the experiences of pioneering agencies that have confronted the risk-control challenge directly, developing operational capacities for specifying risk-concentrations, problem areas, or patterns of noncompliance, and then designing interventions tailored to each problem. At the heart of a new regulatory craftsmanship, according to Sparrow, lies the central notion, "pick important problems and fix them." This beguilingly simple idea turns out to present enormously complex implementation challenges and carries with it profound consequences for the way regulators organize their work, manage their discretion, and report their performance. Although the book is primarily aimed at regulatory and law-enforcement practitioners, it will also be invaluable for legislators, overseers, and others who care about the nature and quality of regulatory practice, and who want to know what kind of performance to demand from regulators and how it might be delivered. It stresses the enormous benefit to society that might accrue from development of the risk-control art as a core professional skill for regulators.

A fully updated edition of the definitive guide to financial regulation In recent years, not only has the compliance field become firmly established, but it has seen staggering growth, thanks to never-ending changes in the regulatory environment. As regulation increases still further, the demand for clear guidance on navigating daily compliance issues is greater than ever. Now in its second edition, the highly successful Essential Strategies for Financial Services Compliance has been updated with the latest compliance strategies and regulatory information, making it indispensable for compliance officers, legal firms, and anyone else working with the financial services compliance function. Non-compliance represents a significant material risk for any financial services firm that fails to understand and appropriately apply regulatory standards. This Second Edition of Essential Strategies for Financial Services Compliance makes it easy to digest complex information on the regulatory framework. But this book is far from solely theoretical. A balanced approach means that both the concepts and their application are within reach. Annie Mills and Peter Haines deliver solid advice that can be applied on a day-to-day basis to manage any compliance issues that may arise. Read this book to: Understand the conceptual basis of compliance and the current regulatory environment applicable to the financial services industry Quickly and thoroughly learn the accepted best practices for everyday compliance Get up to date information on the current financial regulatory environment with this new edition Reference detailed advice as issues arise in day-to-day operations This update to the popular first edition of Essential Strategies for Financial Services Compliance will help eliminate non-compliance risk and ensure that your firm is entirely current on its ability to navigate the maze of financial services regulation.