Download or read book Regulatory Compliance Fundamentals written by M.L. Humphrey and published by M.L. Humphrey. This book was released on 2020-01-02 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Research Regulatory Compliance written by Mark A. Suckow and published by Academic Press. This book was released on 2015-06-14 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Web Accessibility written by Richard Rutter and published by Apress. This book was released on 2007-03-19 with total page 686 pages. Available in PDF, EPUB and Kindle. Book excerpt: Web accessibility not just morally sound – there are legal obligations as well Very large potential audience, consisting of web developers and business managers Very little competition to this book

Download or read book SEC Compliance and Enforcement Answer Book 2015 written by David M. Stuart and published by . This book was released on 2015-08-07 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: SEC Compliance and Enforcement Answer Book 2015 answers hundreds of real-world questions related to the nuances of unique SEC Enforcement procedure, and provides sophisticated insight on the complex and extensive body of federal securities laws. Edited by David M. Stuart (Cravath, Swaine and Moore LLP), this expert Q&A guide compiles the perspectives of leading practitioners from around the country who have previously served in the SEC Enforcement Division, many of whom were in some of the most senior positions in the Division. Leveraging the authors' experience and expertise, SEC Compliance and Enforcement Answer Book 2015 provides nuts and bolts guidance on: - Conducting an effective internal investigation - while the SEC is simultaneously investigating - Responding to SEC requests and subpoenas for documents, interviews, and testimony - Cooperating effectively with SEC staff - The Wells process, negotiating resolutions, and litigating with the SEC - The complexities that arise when criminal and international law enforcement authorities becomes involved in an SEC investigation Additionally, SEC Compliance and Enforcement Answer Book 2015 answers questions on insider trading, accounting and securities fraud, market manipulation and foreign corruption. The Q&A guide also tackles special issues related to investigations of attorneys, accountants, and those identified by whistleblowers.

Download or read book Maintenance Management and Regulatory Compliance Strategies written by Terry Wireman and published by Industrial Press Inc.. This book was released on 2003 with total page 362 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory agencies and their requirements.

Download or read book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals written by John Geigert and published by Springer. This book was released on 2019-05-08 with total page 446 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book The IT Regulatory and Standards Compliance Handbook written by Craig S. Wright and published by Elsevier. This book was released on 2008-07-25 with total page 758 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Download or read book Bank Regulation Risk Management and Compliance written by Alexander Dill and published by Taylor & Francis. This book was released on 2019-10-01 with total page 327 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Explaining Compliance written by Christine Parker and published by Edward Elgar Publishing. This book was released on 2011 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'Taking a broad view of regulation, and covering a wide range of issues and industries, this collection is the most innovative effort to date to understand the responses of business firms to regulation. The book brings together an impressive group of scholars who analyze the concept of compliance and offer theoretically informed studies of its assumed links to regulation. A must read for both academics and practitioners, this ground-breaking collection firmly establishes a scholarly field of compliance studies.' Ronen Shamir, Tel Aviv University, Israel 'Business responses to regulation is a key area of social science research. Parker and Nielsen's collection brings together an excellent group of scholars with innovative, and I believe highly influential contributions that problematize the relations between regulation and compliance. The collection is a highly welcome addition to our field, that will redefine the research agenda on compliance. A significant achievement that will help to improve policy making and frame the scholarly research agenda for the years to come.' David Levi-Faur, The Hebrew University of Jerusalem, Israel and the Free University of Berlin, Germany 'A timely and important set of analyses on how and why businesses respond to regulation in the way that they do from some of the leading authors in the field, covering business responses to both state and non-state regulatory systems.' Julia Black, London School of Economics, UK Explaining Compliance consists of sixteen specially commissioned chapters by the world's leading empirical researchers, examining whether and how businesses comply with regulation that is designed to affect positive behaviour changes. Each chapter consists of reflective summaries on business compliance with different state or voluntary regulation, and the theoretical lessons to be drawn from it. As a whole, the book develops understanding and explanations of how, why and in what circumstances, firms come to comply with regulation, and when they do not. It also uncovers the complexity, ambiguity and transformation of regulation as it is interpreted, implemented and negotiated by firms, their stakeholders and internal constituencies in everyday business life. This unique and detailed resource will appeal to academics, graduate students and senior undergraduates in law, political science, sociology, criminology, economics, and psychology, as well as business and interdisciplinary areas such as law and society, and law and economics. Anyone researching business regulation, corporate social responsibility, regulation and compliance, enforcement and compliance, and public administration, will also find this book beneficial.

Download or read book Medical Device Quality Assurance and Regulatory Compliance written by Richard C. Fries and published by CRC Press. This book was released on 1998-08-11 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

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 The Cambridge Handbook of Compliance written by Benjamin van Rooij and published by Cambridge University Press. This book was released on 2021-05-20 with total page 1559 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book The LegalTech Book written by Sophia Adams Bhatti and published by John Wiley & Sons. This book was released on 2020-06-01 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Written by prominent thought leaders in the global FinTech investment space, The LegalTech Book aggregates diverse expertise into a single, informative volume. Key industry developments are explained in detail, and critical insights from cutting-edge practitioners offer first-hand information and lessons learned. Coverage includes: The current status of LegalTech, why now is the time for it to boom, the drivers behind it, and how it relates to FinTech, RegTech, InsurTech and WealthTech Applications of AI, machine learning and deep learning in the practice of law; e-discovery and due diligence; AI as a legal predictor LegalTech making the law accessible to all; online courts, online dispute resolution The Uberization of the law; hiring and firing through apps Lawbots; social media meets legal advice To what extent does LegalTech make lawyers redundant? Cryptocurrencies, distributed ledger technology and the law The Internet of Things, data privacy, automated contracts Cybersecurity and data Technology vs. the law; driverless cars and liability, legal rights of robots, ownership rights over works created by technology Legislators as innovators"--

Download or read book The AI Book written by Ivana Bartoletti and published by John Wiley & Sons. This book was released on 2020-06-29 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by prominent thought leaders in the global fintech space, The AI Book aggregates diverse expertise into a single, informative volume and explains what artifical intelligence really means and how it can be used across financial services today. Key industry developments are explained in detail, and critical insights from cutting-edge practitioners offer first-hand information and lessons learned. Coverage includes: · Understanding the AI Portfolio: from machine learning to chatbots, to natural language processing (NLP); a deep dive into the Machine Intelligence Landscape; essentials on core technologies, rethinking enterprise, rethinking industries, rethinking humans; quantum computing and next-generation AI · AI experimentation and embedded usage, and the change in business model, value proposition, organisation, customer and co-worker experiences in today’s Financial Services Industry · The future state of financial services and capital markets – what’s next for the real-world implementation of AITech? · The innovating customer – users are not waiting for the financial services industry to work out how AI can re-shape their sector, profitability and competitiveness · Boardroom issues created and magnified by AI trends, including conduct, regulation & oversight in an algo-driven world, cybersecurity, diversity & inclusion, data privacy, the ‘unbundled corporation’ & the future of work, social responsibility, sustainability, and the new leadership imperatives · Ethical considerations of deploying Al solutions and why explainable Al is so important

Download or read book Guide to Supply Chain Compliance Laws and Regulations written by Travis James Miller and published by . This book was released on 2021 with total page 105 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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).