Download or read book Records and Information Management written by Patricia C. Franks and published by American Library Association. This book was released on 2018-08-13 with total page 671 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book's authoritative blend of theory and practice makes it a matchless resource for everyone in the archives and records management field.
Download or read book Collective Management of Copyright and Related Rights written by World Intellectual Property Organization and published by WIPO. This book was released on 2022-12-22 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: This third edition of Collective Management of Copyright and Related Rights presents an in-depth revision with invaluable updates on the different systems, legislative options and best practices of CMOs worldwide. As with previous editions, the book is written to reach a wide audience, with a special focus on questions that might emerge for governments as they prepare, adopt and apply collective management norms and regulations. The edition also sheds light on new copyright and related rights developments, including digital, technological and business trends, from all over the world. Additionally, there is detailed discussion on topics such as aspects of competition, national treatment, and different models of collective management.
Download or read book Privacy Program Management Third Edition written by Russell Densmore and published by . This book was released on 2021-12 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Information Assurance written by and published by . This book was released on 1997 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book EBOOK Management Information Systems Global edition written by James O'Brien and published by McGraw Hill. This book was released on 2011-04-16 with total page 705 pages. Available in PDF, EPUB and Kindle. Book excerpt: The benchmark text for the syllabus organised by technology (a week on databases, a week on networks, a week on systems development, etc.) taught from a managerial perspective. O’Brien's Management Information Systems defines technology and then explains how companies use the technology to improve performance. Real world cases finalise the explanation
Download or read book FDA Regulatory Affairs written by David Mantus and published by CRC Press. This book was released on 2014-02-28 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.
Download or read book Computing Handbook Third Edition written by Heikki Topi and published by CRC Press. This book was released on 2014-05-14 with total page 1526 pages. Available in PDF, EPUB and Kindle. Book excerpt: Computing Handbook, Third Edition: Information Systems and Information Technology demonstrates the richness and breadth of the IS and IT disciplines. The second volume of this popular handbook explores their close links to the practice of using, managing, and developing IT-based solutions to advance the goals of modern organizational environments. Established leading experts and influential young researchers present introductions to the current status and future directions of research and give in-depth perspectives on the contributions of academic research to the practice of IS and IT development, use, and management Like the first volume, this second volume describes what occurs in research laboratories, educational institutions, and public and private organizations to advance the effective development and use of computers and computing in today’s world. Research-level survey articles provide deep insights into the computing discipline, enabling readers to understand the principles and practices that drive computing education, research, and development in the twenty-first century.
Download or read book Regulatory Toxicology Third Edition written by Shayne C. Gad and published by CRC Press. This book was released on 2018-09-03 with total page 311 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical book provides toxicologists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology, Third Edition is an up-to-date guide to required safety assessment for the entire range of man-made marketed products. Individual chapters written by experts with extensive experience in the field address requirements not only for human pharmaceuticals and medical devices (for which there are available guidances), but for the full range of man-made products. New in this edition are three chapters addressing Safety Data Sheet Preparation, Regulatory Requirements for GMOs, and Regulatory Requirements for Tobacco and Marijuana. The major administrative divisions for regulatory agencies and their main responsibilities are also detailed, as are the basic filing documents the agencies require. Coverage includes food additives, dietary supplements, cosmetics, over-the-counter drugs, personal care and consumer products, agriculture and GMO products, industrial chemicals, air and drinking water regulations and the special cases of California’s Proposition 65, requirements for safety data sheets, and oversight regulations. Both US and international requirements are clearly presented and referenced. In one volume, those who have regulatory responsibility in companies, lawyers, educators, and those selling these materials in the marketplace can learn about regulatory requirements and how to meet them.
Download or read book The Alternative Investment Fund Managers Directive written by Dirk A. Zetzsche and published by Kluwer Law International B.V.. This book was released on 2015-09-14 with total page 907 pages. Available in PDF, EPUB and Kindle. Book excerpt: Apart from MiFID, the Alternative Investment Fund Managers Directive (AIFMD) may be the most important European asset management regulation of the early twenty-first century. In this in-depth analytical and critical discussion of the content and system of the directive, thirty-eight contributing authors – academics, lawyers, consultants, fund supervisors, and fund industry experts – examine the AIFMD from every angle. They cover structure, regulatory history, scope, appointment and authorization of the manager, the requirements for depositaries and prime brokers, rules on delegation, reporting requirements, transitional provisions, and the objectives stipulated in the recitals and other official documents. The challenging implications and contexts they examine include the following: – connection with systemic risk and the financial crisis; - nexus with insurance for negligent conduct; - connection with corporate governance doctrine; - risk management; - transparency; - the cross-border dimension; - liability for lost assets; - impact on alternative investment strategies, and - the nexus with the European Regulation on Long-Term Investment Funds (ELTIFR). Nine country reports, representing most of Europe’s financial centres and fund markets add a national perspective to the discussion of the European regulation. These chapters deal with the potential interactions among the AIFMD and the relevant laws and regulations of Austria, France, Germany, Italy, Luxembourg, Liechtenstein, The Netherlands, Malta and the United Kingdom. The second edition of the book continues to deliver not only the much-needed discussion of the inconsistencies and difficulties when applying the directive, but also provides guidance and potential solutions to the problems it raises. The second edition considers all new developments in the field of alternative investment funds, their managers, depositaries, and prime brokers, including, but not limited to, statements by the European Securities and Markets Authority (ESMA) and national competent authorities on the interpretation of the AIFMD, as well as new European regulation, in particular the PRIIPS Regulation, the ELTIF Regulation, the Regulation on European Venture Capital Funds (EuVeCaR), the Regulation on European Social Entrepreneurship Funds (EUSEFR), MiFID II, and UCITS V. The book will be warmly welcomed by investors and their counsel, fund managers, depositaries, asset managers, administrators, as well as regulators and academics in the field.
Download or read book Medical Regulatory Affairs written by Jack Wong and published by CRC Press. This book was released on 2022-01-27 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Download or read book Federal Electronic Records Management written by United States. Congress. House. Committee on Oversight and Government Reform. Subcommittee on Information Policy, Census, and National Archives and published by . This book was released on 2011 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Regulatory Toxicology Third Edition written by Shayne C. Gad and published by CRC Press. This book was released on 2018-09-03 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: • Describes regulatory testing requirements for all the major classes of marketed products • Explains how to prepare required documents for mandated safety testing of product • Features new chapters addressing Safety Data Sheet Preparation and Regulatory Requirements for GMOs • Covers Safety Data Sheet Preparation, which has replaced the Material Safety Data Sheet system
Download or read book Encyclopedia of Information Science and Technology Third Edition written by Khosrow-Pour, Mehdi and published by IGI Global. This book was released on 2014-07-31 with total page 7972 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This 10-volume compilation of authoritative, research-based articles contributed by thousands of researchers and experts from all over the world emphasized modern issues and the presentation of potential opportunities, prospective solutions, and future directions in the field of information science and technology"--Provided by publisher.
Download or read book Drug Discovery and Development Third Edition written by James J. O'Donnell and published by CRC Press. This book was released on 2019-12-13 with total page 899 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business
Download or read book ISO 13485 2016 Medical Devices Quality Management Systems Requirements for Regulatory Purposes written by and published by . This book was released on 2016 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Global Business Regulation written by John Braithwaite and published by Cambridge University Press. This book was released on 2000-02-13 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: How has the regulation of business shifted from national to global institutions? What are the mechanisms of globalization? Who are the key actors? What of democratic sovereignty? In which cases has globalization been successfully resisted? These questions are confronted across an amazing sweep of the critical areas of business regulation--from contract, intellectual property and corporations law, to trade, telecommunications, labor standards, drugs, food, transport and environment. This book examines the role played by global institutions such as the World Trade Organization, World Health Organization, the OECD, IMF, Moodys and the World Bank, as well as various NGOs and significant individuals. Incorporating both history and analysis, Global Business Regulation will become the standard reference for readers in business, law, politics, and international relations.
Download or read book Encyclopedia of Information Science and Technology written by Mehdi Khosrow-Pour and published by IGI Global Snippet. This book was released on 2009 with total page 4292 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This set of books represents a detailed compendium of authoritative, research-based entries that define the contemporary state of knowledge on technology"--Provided by publisher.
