REG 2020 Edition Textbook
| Author | : Roger CPA Review |
| Publisher | : |
| Total Pages | : |
| Release | : 2019-10 |
| Genre | : |
| ISBN | : 9781947298309 |
Reg 2020 Edition Textbook
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A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition
| Author | : Stephen M. Kanovsky |
| Publisher | : |
| Total Pages | : 672 |
| Release | : 2020-09 |
| Genre | : Drugs |
| ISBN | : 9781935065876 |
FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.
The REGTECH Book
| Author | : Janos Barberis |
| Publisher | : John Wiley & Sons |
| Total Pages | : 970 |
| Release | : 2019-08-06 |
| Genre | : Business & Economics |
| ISBN | : 1119362172 |
The Regulatory Technology Handbook The transformational potential of RegTech has been confirmed in recent years with US$1.2 billion invested in start-ups (2017) and an expected additional spending of US$100 billion by 2020. Regulatory technology will not only provide efficiency gains for compliance and reporting functions, it will radically change market structure and supervision. This book, the first of its kind, is providing a comprehensive and invaluable source of information aimed at corporates, regulators, compliance professionals, start-ups and policy makers. The REGTECH Book brings into a single volume the curated industry expertise delivered by subject matter experts. It serves as a single reference point to understand the RegTech eco-system and its impact on the industry. Readers will learn foundational notions such as: • The economic impact of digitization and datafication of regulation • How new technologies (Artificial Intelligence, Blockchain) are applied to compliance • Business use cases of RegTech for cost-reduction and new product origination • The future regulatory landscape affecting financial institutions, technology companies and other industries Edited by world-class academics and written by compliance professionals, regulators, entrepreneurs and business leaders, the RegTech Book represents an invaluable resource that paves the way for 21st century regulatory innovation.
Environmental Justice
| Author | : Clifford Rechtschaffen |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2009 |
| Genre | : Environmental justice |
| ISBN | : 9781594605956 |
Environmental justice is a significant and dynamic contemporary development in environmental law. Rechtschaffen, Gauna and new coauthor O'Neill provide an accessible compilation of interdisciplinary materials for studying environmental justice, interspersed with extensive notes, questions, and a teacher's manual with practice exercises designed to facilitate classroom discussion. It integrates excerpts from empirical studies, cases, agency decisions, informal agency guidance, law reviews, and other academic literature, as well as community-generated documents. This second edition includes new chapters addressing climate change, international environmental justice, and a capstone case study. It also adds expanded coverage of risk and the public health, empirical environmental justice research, and environmental justice for American Indian peoples.
Mastering Legislation, Regulation, and Statutory Interpretation
| Author | : Linda D. Jellum |
| Publisher | : |
| Total Pages | : 562 |
| Release | : 2019-12-27 |
| Genre | : |
| ISBN | : 9781531012021 |
The Brussels Effect
| Author | : Anu Bradford |
| Publisher | : Oxford University Press |
| Total Pages | : 368 |
| Release | : 2020-01-27 |
| Genre | : Law |
| ISBN | : 0190088605 |
For many observers, the European Union is mired in a deep crisis. Between sluggish growth; political turmoil following a decade of austerity politics; Brexit; and the rise of Asian influence, the EU is seen as a declining power on the world stage. Columbia Law professor Anu Bradford argues the opposite in her important new book The Brussels Effect: the EU remains an influential superpower that shapes the world in its image. By promulgating regulations that shape the international business environment, elevating standards worldwide, and leading to a notable Europeanization of many important aspects of global commerce, the EU has managed to shape policy in areas such as data privacy, consumer health and safety, environmental protection, antitrust, and online hate speech. And in contrast to how superpowers wield their global influence, the Brussels Effect - a phrase first coined by Bradford in 2012- absolves the EU from playing a direct role in imposing standards, as market forces alone are often sufficient as multinational companies voluntarily extend the EU rule to govern their global operations. The Brussels Effect shows how the EU has acquired such power, why multinational companies use EU standards as global standards, and why the EU's role as the world's regulator is likely to outlive its gradual economic decline, extending the EU's influence long into the future.
Regulation of Lawyers
| Author | : Stephen Gillers |
| Publisher | : Aspen Publishers |
| Total Pages | : 1128 |
| Release | : 2002 |
| Genre | : Law |
| ISBN | : |
For its Sixth Edition, this extremely popular casebook continues to mix up-to-date materials with realistic problems to illustrate and demonstrate the full range of ethical issues facing lawyers and judges. Regulation of Lawyers builds on the strengths that earned it such widespread adoption: written by Professor Stephen Gillers, a recognized national authority on the subject in-depth, thorough treatment of the issues in a lively, accessible style covers the full range of professional responsibility topics, including conflicts of interest, special lawyer roles, and avoiding and redressing professional failure with three chapters on control of quality realistic problems (many of which are new or revised) help students Understand The rules and regulations that will govern their professional behavior combines cases, law review articles, excerpts from a wide variety of popular sources, and engaging problems to give variety and vividness accompanied by the most comprehensive annual statutory supplement in the field Regulation of Lawyers: Statutes and Standards, co-authored by Roy D. Simon with major, minor, and state variations of the rules governing lawyers and judges the Sixth Edition incorporates important new material: the no-contact and other ethics rules as they apply to state and federal law enforcers proposed changes in the Model Rules of Professional Conduct new cases on excessive fees (Matter of Fordham), using gender biased terms in a deposition (Mullaney v. Aude), liability for securities and common law fraud arising out of a negotiation for investment in a business (Rubin v. Schottenstein, Zox, & Dunn), And The unauthorized practice of law by lawyers from outside a state (Birbrower, Montalbano, Condon & Frank, P.C. v. Superior Court) coverage of the Clinton/Lewinsky matter And The ethical questions raised by the investigation conducted by Ken Starr to give students a clear understanding of their professional responsibilities from the client-lawyer relationship to their First Amendment rights use the casebook that has been proven effective in the classroom: Gillers' Regulation of Lawyers, Sixth Edition .
Food Regulation
| Author | : Neal D. Fortin |
| Publisher | : John Wiley & Sons |
| Total Pages | : 1028 |
| Release | : 2016-10-25 |
| Genre | : Technology & Engineering |
| ISBN | : 1118964497 |
Featuring case studies and discussion questions, this textbook – with revisions addressing significant changes to US food law – offers accessible coverage appropriate to a wide audience of students and professionals. Overviews the federal statutes, regulations, and regulatory agencies concerned with food regulation and introduces students to the case law and statutory scheme of food regulation Focuses updated content on the 2011 FDA Food Safety Modernization Act (FSMA), the biggest change to US food law since the 1930s Contains over 20% new material, particularly a rewritten import law chapter and revisions related to food safety regulation, health claims, and food defense Features case studies and discussion questions about application of law, policy questions, and emerging issues
Insurance Law and Regulation
| Author | : Kenneth S. Abraham |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2015 |
| Genre | : Insurance law |
| ISBN | : 9781609304010 |
This casebook, which has been used as the principal text in more than one hundred law schools, contains extensive material on insurance contract formation and interpretation; insurance regulation; insurable interest and liability for bad-faith breach; property, health, life, and disability insurance; commercial general liability and directors & officers liability insurance; auto insurance; and reinsurance. The casebook gives equal emphasis to personal and commercial insurance, and reprints within the relevant chapters four standard-form insurance policies. There is new material on the interpretation of ambiguities, insurance regulation, the Affordable Care Act, directors & officers insurance, and excess coverage.
Mastering Statutory Interpretation
| Author | : Linda D. Jellum |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2013 |
| Genre | : Law |
| ISBN | : 9781611634563 |
Mastering Statutory Interpretation explains the methods of interpreting statutes, including a discussion of the various theories and canons of interpretation. The book begins by exploring these theories and identifying the sources of meaning the theorists use to interpret statutes, including intrinsic, extrinsic, and policy-based. Throughout, the text uses the major cases in each area of study to explain how the canons work in practice. Finally, each chapter provides a concise roadmap and summary to introduce and encapsulate the most important material. The second edition adds one new chapter to address the administrative issues that faculty teaching legislation and regulation need, as well as a running hypothetical to help students better implement what they are learning.
