Regulatory Compliance Fundamentals


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




International Compliance 101 :


Book Description




The Challenge of CMC Regulatory Compliance for Biopharmaceuticals


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.




Compliance Management


Book Description

This practical guide shows how to build an effective compliance and ethics program that will lower a business's risks and improve productivity. Research increasingly supports the notion that ethical, compliant businesses see increased productivity across a range of measurements. This practical guide tells business professionals, business and law students, and other interested parties exactly how that goal can be achieved. The book covers an extensive range of ethics-compliant laws and regulations impacting businesses today and identifies critical factors for successful compliance programs. Going well beyond works that speak in general terms about compliance-based actions, this unique volume delves into details about specific regulatory issues and the steps that can be taken to mitigate risk. The first half of the book shares general guidelines for creating or improving internal compliance and ethics programs. The second half identifies specific, high-risk regulatory areas; provides an overview of relevant laws; and sets forth best practices specific to the regulations discussed. By providing a simplified understanding of compliance with laws related to issues such as antitrust, international business, wages and labor, Health Insurance Portability and Accountability Act (HIPAA) and health care, the environment and more, the guide offers readers the tools necessary to improve an existing compliance program or create a new program where none has existed before.




The IT Regulatory and Standards Compliance Handbook


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




Bank Regulation, Risk Management, and Compliance


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.




AML Compliance Fundamentals


Book Description

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




Fundamentals of Biologicals Regulation


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




The Compliance Revolution


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.