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Author: M.L. Humphrey Publisher: M.L. Humphrey ISBN: Category : Business & Economics Languages : en Pages : 68
Book Description
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
Author: M.L. Humphrey Publisher: M.L. Humphrey ISBN: Category : Business & Economics Languages : en Pages : 68
Book Description
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
Author: David Jackman Publisher: John Wiley & Sons ISBN: 111902059X Category : Business & Economics Languages : en Pages : 224
Book Description
The Compliance Revolution—Practical, Powerful Changes for Strategic Organizational Value Compliance is absolutely critical in creating a robust and resilient organization, one which is trusted by clients and contributes to market stability. Firms must approach compliance differently in order to meet these standards. Written for compliance staff, regulatory organizations, and senior management, The Compliance Revolution explains how key changes in compliance affect underlying principles, practices, roles, expectations and values. This valuable resource for global practitioners assists in navigating compliance requirements and implementing solid protection for a sound organization. Author David Jackman presents a coherent model for understanding and applying key developments in regulation and compliance. While the model is based on financial services, it can be applied to any sector and industry. It identifies five critical compliance components: Start-up, crises, expansion, sustainability, and outcomes-led focus. You will also discover: Why compliance is worth spending money on What your firm could and should be doing differently The importance of ethics in compliance and regulatory challenges How to create a pro-compliance culture Ten principles of good governance and why good governance matters How to employ judgment-based compliance The features and benefits of corporate maturity The Compliance Revolution is a crucial asset for all those with stakes in compliance—board members, compliance managers, and employees. David Jackman outlines key compliance challenges and reveals the practical tools and techniques required for successful practice. The insight, examples, and strategies in this comprehensive guidebook will help you and your organization achieve increasingly efficient, substantially more effective compliance procedures and practices.
Author: John Geigert Publisher: Springer ISBN: 3030137546 Category : Medical Languages : en Pages : 446
Book Description
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.
Author: Craig S. Wright Publisher: Elsevier ISBN: 0080560172 Category : Computers Languages : en Pages : 758
Book Description
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
Author: Alexander Dill Publisher: Taylor & Francis ISBN: 1000702731 Category : Law Languages : en Pages : 345
Book Description
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.
Author: Rebecca Sheets Publisher: Academic Press ISBN: 0128094435 Category : Medical Languages : en Pages : 452
Book Description
Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals. - Provides a broad overview and introduction to the regulatory processes, from product development pathways, through clinical trials and product development stages and beyond - Includes FDA, EMA, ICH, and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different - Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated - Includes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products
Author: Barry D. Alexander Publisher: ISBN: 9781422489611 Category : Medical care Languages : en Pages : 564
Book Description
This specialized and complex field of health law requires a thorough grounding in the basics, and Fundamentals of Health Law, 5th Edition, provides that grounding like no other book on the market does. This new edition has been thoroughly revised and made current to cover the basic issues of health law practice, from patient to facility issues, from permits and regulation issues to compliance and investigation issues, and includes issues raised by new laws, regulations and guidelines promulgated since the fourth edition in 2008, including the Affordable Care Act (ACA). This publication covers fundamental legal principles and issues to assist: * New Practitioners or experienced attorneys entering their first years of health-law practice; * Professors of health law searching for a comprehensive text for their students; and * Users of any law library looking for answers on the health law resource shelf.
Author: M.L. Humphrey
Author: M.L. Humphrey
Author: David Jackman
Author: Debbie Troklus
Author: John Geigert
Author: 
Author: Craig S. Wright
Author: Alexander Dill
Author: M. L. Humphrey
Author: Rebecca Sheets
Author: Barry D. Alexander