Global Approach in Safety Testing


Book Description

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”.




Engineering a Safer World


Book Description

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.




Keeping Patients Safe


Book Description

Building on the revolutionary Institute of Medicine reports To Err is Human and Crossing the Quality Chasm, Keeping Patients Safe lays out guidelines for improving patient safety by changing nurses' working conditions and demands. Licensed nurses and unlicensed nursing assistants are critical participants in our national effort to protect patients from health care errors. The nature of the activities nurses typically perform â€" monitoring patients, educating home caretakers, performing treatments, and rescuing patients who are in crisis â€" provides an indispensable resource in detecting and remedying error-producing defects in the U.S. health care system. During the past two decades, substantial changes have been made in the organization and delivery of health care â€" and consequently in the job description and work environment of nurses. As patients are increasingly cared for as outpatients, nurses in hospitals and nursing homes deal with greater severity of illness. Problems in management practices, employee deployment, work and workspace design, and the basic safety culture of health care organizations place patients at further risk. This newest edition in the groundbreaking Institute of Medicine Quality Chasm series discusses the key aspects of the work environment for nurses and reviews the potential improvements in working conditions that are likely to have an impact on patient safety.




Science, Medicine, and Animals


Book Description

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.




System Safety Engineering and Risk Assessment


Book Description

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




Global status report on road safety 2023


Book Description




The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment


Book Description

The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area. - Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more - Includes practical examples on techniques and methods to guide your daily practice - Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes




The Interplay of Global Standards and EU Pharmaceutical Regulation


Book Description

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.




Ensuring Global Food Safety


Book Description

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




Preclinical Safety Evaluation of Biopharmaceuticals


Book Description

"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.