Global Approach in Safety Testing

Global Approach in Safety Testing PDF

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”.

Science, Medicine, and Animals

Science, Medicine, and Animals PDF

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.

Safety-I and Safety-II

Safety-I and Safety-II PDF

Author: Erik Hollnagel

Publisher: CRC Press

Published: 2018-04-17

Total Pages: 167

ISBN-13: 1317059794

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Safety has traditionally been defined as a condition where the number of adverse outcomes was as low as possible (Safety-I). From a Safety-I perspective, the purpose of safety management is to make sure that the number of accidents and incidents is kept as low as possible, or as low as is reasonably practicable. This means that safety management must start from the manifestations of the absence of safety and that - paradoxically - safety is measured by counting the number of cases where it fails rather than by the number of cases where it succeeds. This unavoidably leads to a reactive approach based on responding to what goes wrong or what is identified as a risk - as something that could go wrong. Focusing on what goes right, rather than on what goes wrong, changes the definition of safety from ’avoiding that something goes wrong’ to ’ensuring that everything goes right’. More precisely, Safety-II is the ability to succeed under varying conditions, so that the number of intended and acceptable outcomes is as high as possible. From a Safety-II perspective, the purpose of safety management is to ensure that as much as possible goes right, in the sense that everyday work achieves its objectives. This means that safety is managed by what it achieves (successes, things that go right), and that likewise it is measured by counting the number of cases where things go right. In order to do this, safety management cannot only be reactive, it must also be proactive. But it must be proactive with regard to how actions succeed, to everyday acceptable performance, rather than with regard to how they can fail, as traditional risk analysis does. This book analyses and explains the principles behind both approaches and uses this to consider the past and future of safety management practices. The analysis makes use of common examples and cases from domains such as aviation, nuclear power production, process management and health care. The final chapters explain the theoret

System Safety Engineering and Risk Assessment

System Safety Engineering and Risk Assessment PDF

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

Engineering a Safer World

Engineering a Safer World PDF

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.

The Interplay of Global Standards and EU Pharmaceutical Regulation

The Interplay of Global Standards and EU Pharmaceutical Regulation PDF

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.

Resilient Health Care

Resilient Health Care PDF

Author: Erik Hollnagel

Publisher: CRC Press

Published: 2019-07-23

Total Pages: 254

ISBN-13: 1317065166

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Health care is everywhere under tremendous pressure with regard to efficiency, safety, and economic viability - to say nothing of having to meet various political agendas - and has responded by eagerly adopting techniques that have been useful in other industries, such as quality management, lean production, and high reliability. This has on the whole been met with limited success because health care as a non-trivial and multifaceted system differs significantly from most traditional industries. In order to allow health care systems to perform as expected and required, it is necessary to have concepts and methods that are able to cope with this complexity. Resilience engineering provides that capacity because its focus is on a system’s overall ability to sustain required operations under both expected and unexpected conditions rather than on individual features or qualities. Resilience engineering’s unique approach emphasises the usefulness of performance variability, and that successes and failures have the same aetiology. This book contains contributions from acknowledged international experts in health care, organisational studies and patient safety, as well as resilience engineering. Whereas current safety approaches primarily aim to reduce or eliminate the number of things that go wrong, Resilient Health Care aims to increase and improve the number of things that go right. Just as the WHO argues that health is more than the absence of illness, so does Resilient Health Care argue that safety is more than the absence of risk and accidents. This can be achieved by making use of the concrete experiences of resilience engineering, both conceptually (ways of thinking) and practically (ways of acting).

Finite Element Analysis for Building Assessment

Finite Element Analysis for Building Assessment PDF

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.

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