Global Approach in Safety Testing

Global Approach in Safety Testing

Author: Jan Willem van der Laan

Publisher: Springer Science & Business Media

Published: 2013-02-11

Total Pages: 322

ISBN-13: 1461459508

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This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the “lessons learnt” and “future developments”.


Book Synopsis Global Approach in Safety Testing by : Jan Willem van der Laan

Download or read book Global Approach in Safety Testing written by Jan Willem van der Laan and published by Springer Science & Business Media. This book was released on 2013-02-11 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the “lessons learnt” and “future developments”.

Science, Medicine, and Animals

Science, Medicine, and Animals

Author: National Research Council

Publisher: National Academies Press

Published: 2006-02-19

Total Pages: 23

ISBN-13: 0309101174

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Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher's Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher's Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher's Guide was reviewed by members of the National Academies' Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher's Association NSTA Recommends.


Book Synopsis Science, Medicine, and Animals by : National Research Council

Download or read book Science, Medicine, and Animals written by National Research Council and published by National Academies Press. This book was released on 2006-02-19 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher's Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher's Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher's Guide was reviewed by members of the National Academies' Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher's Association NSTA Recommends.

Toxicokinetics

Toxicokinetics

Author:

Publisher:

Published: 1995

Total Pages: 24

ISBN-13:

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Book Synopsis Toxicokinetics by :

Download or read book Toxicokinetics written by and published by . This book was released on 1995 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:

System Safety Engineering and Risk Assessment

System Safety Engineering and Risk Assessment

Author: Nicholas J. Bahr

Publisher: CRC Press

Published: 2018-10-08

Total Pages: 444

ISBN-13: 1466551615

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We all know that safety should be an integral part of the systems that we build and operate. The public demands that they are protected from accidents, yet industry and government do not always know how to reach this common goal. This book gives engineers and managers working in companies and governments around the world a pragmatic and reasonable approach to system safety and risk assessment techniques. It explains in easy-to-understand language how to design workable safety management systems and implement tested solutions immediately. The book is intended for working engineers who know that they need to build safe systems, but aren’t sure where to start. To make it easy to get started quickly, it includes numerous real-life engineering examples. The book’s many practical tips and best practices explain not only how to prevent accidents, but also how to build safety into systems at a sensible price. The book also includes numerous case studies from real disasters that describe what went wrong and the lessons learned. See What’s New in the Second Edition: New chapter on developing government safety oversight programs and regulations, including designing and setting up a new safety regulatory body, developing safety regulatory oversight functions and governance, developing safety regulations, and how to avoid common mistakes in government oversight Significantly expanded chapter on safety management systems, with many practical applications from around the world and information about designing and building robust safety management systems, auditing them, gaining internal support, and creating a safety culture New and expanded case studies and "Notes from Nick’s Files" (examples of practical applications from the author’s extensive experience) Increased international focus on world-leading practices from multiple industries with practical examples, common mistakes to avoid, and new thinking about how to build sustainable safety management systems New material on safety culture, developing leading safety performance indicators, safety maturity model, auditing safety management systems, and setting up a safety knowledge management system


Book Synopsis System Safety Engineering and Risk Assessment by : Nicholas J. Bahr

Download or read book System Safety Engineering and Risk Assessment written by Nicholas J. Bahr and published by CRC Press. This book was released on 2018-10-08 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: We all know that safety should be an integral part of the systems that we build and operate. The public demands that they are protected from accidents, yet industry and government do not always know how to reach this common goal. This book gives engineers and managers working in companies and governments around the world a pragmatic and reasonable approach to system safety and risk assessment techniques. It explains in easy-to-understand language how to design workable safety management systems and implement tested solutions immediately. The book is intended for working engineers who know that they need to build safe systems, but aren’t sure where to start. To make it easy to get started quickly, it includes numerous real-life engineering examples. The book’s many practical tips and best practices explain not only how to prevent accidents, but also how to build safety into systems at a sensible price. The book also includes numerous case studies from real disasters that describe what went wrong and the lessons learned. See What’s New in the Second Edition: New chapter on developing government safety oversight programs and regulations, including designing and setting up a new safety regulatory body, developing safety regulatory oversight functions and governance, developing safety regulations, and how to avoid common mistakes in government oversight Significantly expanded chapter on safety management systems, with many practical applications from around the world and information about designing and building robust safety management systems, auditing them, gaining internal support, and creating a safety culture New and expanded case studies and "Notes from Nick’s Files" (examples of practical applications from the author’s extensive experience) Increased international focus on world-leading practices from multiple industries with practical examples, common mistakes to avoid, and new thinking about how to build sustainable safety management systems New material on safety culture, developing leading safety performance indicators, safety maturity model, auditing safety management systems, and setting up a safety knowledge management system

Engineering a Safer World

Engineering a Safer World

Author: Nancy G. Leveson

Publisher: MIT Press

Published: 2012-01-13

Total Pages: 555

ISBN-13: 0262297302

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A new approach to safety, based on systems thinking, that is more effective, less costly, and easier to use than current techniques. Engineering has experienced a technological revolution, but the basic engineering techniques applied in safety and reliability engineering, created in a simpler, analog world, have changed very little over the years. In this groundbreaking book, Nancy Leveson proposes a new approach to safety—more suited to today's complex, sociotechnical, software-intensive world—based on modern systems thinking and systems theory. Revisiting and updating ideas pioneered by 1950s aerospace engineers in their System Safety concept, and testing her new model extensively on real-world examples, Leveson has created a new approach to safety that is more effective, less expensive, and easier to use than current techniques. Arguing that traditional models of causality are inadequate, Leveson presents a new, extended model of causation (Systems-Theoretic Accident Model and Processes, or STAMP), then shows how the new model can be used to create techniques for system safety engineering, including accident analysis, hazard analysis, system design, safety in operations, and management of safety-critical systems. She applies the new techniques to real-world events including the friendly-fire loss of a U.S. Blackhawk helicopter in the first Gulf War; the Vioxx recall; the U.S. Navy SUBSAFE program; and the bacterial contamination of a public water supply in a Canadian town. Leveson's approach is relevant even beyond safety engineering, offering techniques for “reengineering” any large sociotechnical system to improve safety and manage risk.


Book Synopsis Engineering a Safer World by : Nancy G. Leveson

Download or read book Engineering a Safer World written by Nancy G. Leveson and published by MIT Press. This book was released on 2012-01-13 with total page 555 pages. Available in PDF, EPUB and Kindle. Book excerpt: A new approach to safety, based on systems thinking, that is more effective, less costly, and easier to use than current techniques. Engineering has experienced a technological revolution, but the basic engineering techniques applied in safety and reliability engineering, created in a simpler, analog world, have changed very little over the years. In this groundbreaking book, Nancy Leveson proposes a new approach to safety—more suited to today's complex, sociotechnical, software-intensive world—based on modern systems thinking and systems theory. Revisiting and updating ideas pioneered by 1950s aerospace engineers in their System Safety concept, and testing her new model extensively on real-world examples, Leveson has created a new approach to safety that is more effective, less expensive, and easier to use than current techniques. Arguing that traditional models of causality are inadequate, Leveson presents a new, extended model of causation (Systems-Theoretic Accident Model and Processes, or STAMP), then shows how the new model can be used to create techniques for system safety engineering, including accident analysis, hazard analysis, system design, safety in operations, and management of safety-critical systems. She applies the new techniques to real-world events including the friendly-fire loss of a U.S. Blackhawk helicopter in the first Gulf War; the Vioxx recall; the U.S. Navy SUBSAFE program; and the bacterial contamination of a public water supply in a Canadian town. Leveson's approach is relevant even beyond safety engineering, offering techniques for “reengineering” any large sociotechnical system to improve safety and manage risk.

The Interplay of Global Standards and EU Pharmaceutical Regulation

The Interplay of Global Standards and EU Pharmaceutical Regulation

Author: Sabrina Röttger-Wirtz

Publisher: Bloomsbury Publishing

Published: 2021-08-26

Total Pages: 288

ISBN-13: 1509943013

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This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.


Book Synopsis The Interplay of Global Standards and EU Pharmaceutical Regulation by : Sabrina Röttger-Wirtz

Download or read book The Interplay of Global Standards and EU Pharmaceutical Regulation written by Sabrina Röttger-Wirtz and published by Bloomsbury Publishing. This book was released on 2021-08-26 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.

Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies

Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies

Author: OECD

Publisher: OECD Publishing

Published: 2019-10-17

Total Pages: 447

ISBN-13: 9264805907

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This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.


Book Synopsis Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies by : OECD

Download or read book Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

Proceedings of the 5th International Probabilistic Workshop

Proceedings of the 5th International Probabilistic Workshop

Author: Luc Taerwe

Publisher: Dirk Proske Verlag

Published: 2007

Total Pages: 396

ISBN-13: 3000220305

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Book Synopsis Proceedings of the 5th International Probabilistic Workshop by : Luc Taerwe

Download or read book Proceedings of the 5th International Probabilistic Workshop written by Luc Taerwe and published by Dirk Proske Verlag. This book was released on 2007 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Finite Element Analysis for Building Assessment

Finite Element Analysis for Building Assessment

Author: Paulo B. Lourenço

Publisher: Taylor & Francis

Published: 2022-05-23

Total Pages: 423

ISBN-13: 100056312X

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Existing structures represent a heterogeneous category in the global built environment as often characterized by the presence of archaic materials, damage and disconnections, uncommon construction techniques and subsequent interventions throughout the building history. In this scenario, the common linear elastic analysis approach adopted for new buildings is incapable of an accurate estimation of structural capacity, leading to overconservative results, invasive structural strengthening, added intervention costs, excessive interference to building users and possible losses in terms of aesthetics or heritage values. For a rational and sustainable use of the resources, this book deals with advanced numerical simulations, adopting a practical approach to introduce the fundamentals of Finite Element Method, nonlinear solution procedures and constitutive material models. Recommended material properties for masonry, timber, reinforced concrete, iron and steel are discussed according to experimental evidence, building standards and codes of practice. The examples examined throughout the book and in the conclusive chapter support the analyst’s decision-making process toward a safe and efficient use of finite element analysis. Written primarily for practicing engineers, the book is of value to students in engineering and technical architecture with solid knowledge in the field of continuum mechanics and structural design.


Book Synopsis Finite Element Analysis for Building Assessment by : Paulo B. Lourenço

Download or read book Finite Element Analysis for Building Assessment written by Paulo B. Lourenço and published by Taylor & Francis. This book was released on 2022-05-23 with total page 423 pages. Available in PDF, EPUB and Kindle. Book excerpt: Existing structures represent a heterogeneous category in the global built environment as often characterized by the presence of archaic materials, damage and disconnections, uncommon construction techniques and subsequent interventions throughout the building history. In this scenario, the common linear elastic analysis approach adopted for new buildings is incapable of an accurate estimation of structural capacity, leading to overconservative results, invasive structural strengthening, added intervention costs, excessive interference to building users and possible losses in terms of aesthetics or heritage values. For a rational and sustainable use of the resources, this book deals with advanced numerical simulations, adopting a practical approach to introduce the fundamentals of Finite Element Method, nonlinear solution procedures and constitutive material models. Recommended material properties for masonry, timber, reinforced concrete, iron and steel are discussed according to experimental evidence, building standards and codes of practice. The examples examined throughout the book and in the conclusive chapter support the analyst’s decision-making process toward a safe and efficient use of finite element analysis. Written primarily for practicing engineers, the book is of value to students in engineering and technical architecture with solid knowledge in the field of continuum mechanics and structural design.

Ensuring Global Food Safety

Ensuring Global Food Safety

Author: Christine Boisrobert

Publisher: Academic Press

Published: 2009-11-11

Total Pages: 475

ISBN-13: 0080889301

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Taking into account toxicity levels at normal consumption levels, intake per kg bodyweight and other acknowledged considerations, each chapter in this book will be based on one or more proven examples. It is intended to provide specific examples and potential improvements to the safety of the world's food supply, while also increasing the amount of food available to those in undernourished countries. This book is designed to to provide science-based tools for improving legislation and regulation. Reduce amount of food destroyed due to difference in regulations between nations Positively impact the time-to-market of new food products by recognizing benefit of "one rule that applies to all" Use the comparison of regulations and resulting consequences to make appropriate, fully-informed decisions Employ proven science to obtain global consensus for regulations Understand how to harmonize test protocols and analytical methods for accurate measurement and evaluation Take advantage of using a risk/benefit based approach rather than risk/avoidance to maximize regulatory decisions


Book Synopsis Ensuring Global Food Safety by : Christine Boisrobert

Download or read book Ensuring Global Food Safety written by Christine Boisrobert and published by Academic Press. This book was released on 2009-11-11 with total page 475 pages. Available in PDF, EPUB and Kindle. Book excerpt: Taking into account toxicity levels at normal consumption levels, intake per kg bodyweight and other acknowledged considerations, each chapter in this book will be based on one or more proven examples. It is intended to provide specific examples and potential improvements to the safety of the world's food supply, while also increasing the amount of food available to those in undernourished countries. This book is designed to to provide science-based tools for improving legislation and regulation. Reduce amount of food destroyed due to difference in regulations between nations Positively impact the time-to-market of new food products by recognizing benefit of "one rule that applies to all" Use the comparison of regulations and resulting consequences to make appropriate, fully-informed decisions Employ proven science to obtain global consensus for regulations Understand how to harmonize test protocols and analytical methods for accurate measurement and evaluation Take advantage of using a risk/benefit based approach rather than risk/avoidance to maximize regulatory decisions