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| benefits of risk assessment: Risk Assessment in the Federal Government National Research Council, Division on Earth and Life Studies, Commission on Life Sciences, Committee on the Institutional Means for Assessment of Risks to Public Health, 1983-02-01 The regulation of potentially hazardous substances has become a controversial issue. This volume evaluates past efforts to develop and use risk assessment guidelines, reviews the experience of regulatory agencies with different administrative arrangements for risk assessment, and evaluates various proposals to modify procedures. The book's conclusions and recommendations can be applied across the entire field of environmental health. |
| benefits of risk assessment: Potential Risks and Benefits of Gain-of-Function Research National Research Council, Institute of Medicine, Board on Health Sciences Policy, Policy and Global Affairs, Committee on Science, Technology, and Law, Division on Earth and Life Studies, Board on Life Sciences, 2015-04-13 On October 17, 2014, spurred by incidents at U.S. government laboratories that raised serious biosafety concerns, the United States government launched a one-year deliberative process to address the continuing controversy surrounding so-called gain-of-function (GOF) research on respiratory pathogens with pandemic potential. The gain of function controversy began in late 2011 with the question of whether to publish the results of two experiments involving H5N1 avian influenza and continued to focus on certain research with highly pathogenic avian influenza over the next three years. The heart of the U.S. process is an evaluation of the potential risks and benefits of certain types of GOF experiments with influenza, SARS, and MERS viruses that would inform the development and adoption of a new U.S. Government policy governing the funding and conduct of GOF research. Potential Risks and Benefits of Gain-of-Function Research is the summary of a two-day public symposia on GOF research. Convened in December 2014 by the Institute of Medicine and the National Research Council, the main focus of this event was to discuss principles important for, and key considerations in, the design of risk and benefit assessments of GOF research. Participants examined the underlying scientific and technical questions that are the source of current discussion and debate over GOF research involving pathogens with pandemic potential. This report is a record of the presentations and discussion of the meeting. |
| benefits of risk assessment: Benefit-Risk Assessment of Medicines James Leong, Sam Salek, Stuart Walker, 2015-04-21 This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally. |
| benefits of risk assessment: The Cambridge Handbook of Health Research Regulation Graeme Laurie, Edward Dove, Agomoni Ganguli-Mitra, Catriona McMillan, Emily Postan, Nayha Sethi, Annie Sorbie, 2021-06-09 The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues. |
| benefits of risk assessment: Benefit-Risk Assessment in Pharmaceutical Research and Development Andreas Sashegyi, James Felli, Rebecca Noel, 2013-11-27 Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization. Helping to alleviate this knowledge gap, Benefit-Risk Assessment in Pharmaceutical Research and Development provides a succinct overview of the key considerations rele |
| benefits of risk assessment: Occupational Health and Safety in the Care and Use of Nonhuman Primates National Research Council, Division on Earth and Life Studies, Institute for Laboratory Animal Research, Committee on Occupational Health and Safety in the Care and Use of Nonhuman Primates, 2003-06-13 The field of occupational health and safety constantly changes, especially as it pertains to biomedical research. New infectious hazards are of particular importance at nonhuman-primate facilities. For example, the discovery that B virus can be transmitted via a splash on a mucous membrane raises new concerns that must be addressed, as does the discovery of the Reston strain of Ebola virus in import quarantine facilities in the U.S. The risk of such infectious hazards is best managed through a flexible and comprehensive Occupational Health and Safety Program (OHSP) that can identify and mitigate potential hazards. Occupational Health and Safety in the Care and Use of Nonhuman Primates is intended as a reference for vivarium managers, veterinarians, researchers, safety professionals, and others who are involved in developing or implementing an OHSP that deals with nonhuman primates. The book lists the important features of an OHSP and provides the tools necessary for informed decision-making in developing an optimal program that meets all particular institutional needs. |
| benefits of risk assessment: Science and Decisions National Research Council, Division on Earth and Life Studies, Board on Environmental Studies and Toxicology, Committee on Improving Risk Analysis Approaches Used by the U.S. EPA, 2009-03-24 Risk assessment has become a dominant public policy tool for making choices, based on limited resources, to protect public health and the environment. It has been instrumental to the mission of the U.S. Environmental Protection Agency (EPA) as well as other federal agencies in evaluating public health concerns, informing regulatory and technological decisions, prioritizing research needs and funding, and in developing approaches for cost-benefit analysis. However, risk assessment is at a crossroads. Despite advances in the field, risk assessment faces a number of significant challenges including lengthy delays in making complex decisions; lack of data leading to significant uncertainty in risk assessments; and many chemicals in the marketplace that have not been evaluated and emerging agents requiring assessment. Science and Decisions makes practical scientific and technical recommendations to address these challenges. This book is a complement to the widely used 1983 National Academies book, Risk Assessment in the Federal Government (also known as the Red Book). The earlier book established a framework for the concepts and conduct of risk assessment that has been adopted by numerous expert committees, regulatory agencies, and public health institutions. The new book embeds these concepts within a broader framework for risk-based decision-making. Together, these are essential references for those working in the regulatory and public health fields. |
| benefits of risk assessment: Science and Judgment in Risk Assessment National Research Council, Division on Earth and Life Studies, Board on Environmental Studies and Toxicology, Commission on Life Sciences, Committee on Risk Assessment of Hazardous Air Pollutants, 1994-01-01 The public depends on competent risk assessment from the federal government and the scientific community to grapple with the threat of pollution. When risk reports turn out to be overblownâ€or when risks are overlookedâ€public skepticism abounds. This comprehensive and readable book explores how the U.S. Environmental Protection Agency (EPA) can improve its risk assessment practices, with a focus on implementation of the 1990 Clean Air Act Amendments. With a wealth of detailed information, pertinent examples, and revealing analysis, the volume explores the default option and other basic concepts. It offers two views of EPA operations: The first examines how EPA currently assesses exposure to hazardous air pollutants, evaluates the toxicity of a substance, and characterizes the risk to the public. The second, more holistic, view explores how EPA can improve in several critical areas of risk assessment by focusing on cross-cutting themes and incorporating more scientific judgment. This comprehensive volume will be important to the EPA and other agencies, risk managers, environmental advocates, scientists, faculty, students, and concerned individuals. |
| benefits of risk assessment: Issues in Risk Assessment National Research Council, Division on Earth and Life Studies, Commission on Life Sciences, Committee on Risk Assessment Methodology, 1993-02-01 The scientific basis, inference assumptions, regulatory uses, and research needs in risk assessment are considered in this two-part volume. The first part, Use of Maximum Tolerated Dose in Animal Bioassays for Carcinogenicity, focuses on whether the maximum tolerated dose should continue to be used in carcinogenesis bioassays. The committee considers several options for modifying current bioassay procedures. The second part, Two-Stage Models of Carcinogenesis, stems from efforts to identify improved means of cancer risk assessment that have resulted in the development of a mathematical dose-response model based on a paradigm for the biologic phenomena thought to be associated with carcinogenesis. |
| benefits of risk assessment: Risk Management and Assessment Jorge Rocha, Sandra Oliveira, César Capinha, 2020-10-14 Risk analysis, risk evaluation and risk management are the three core areas in the process known as 'Risk Assessment'. Risk assessment corresponds to the joint effort of identifying and analysing potential future events, and evaluating the acceptability of risk based on the risk analysis, while considering influencing factors. In short, risk assessment analyses what can go wrong, how likely it is to happen and, if it happens, what are the potential consequences. Since risk is a multi-disciplinary domain, this book gathers contributions covering a wide spectrum of topics with regard to their theoretical background and field of application. The work is organized in the three core areas of risk assessment. |
| benefits of risk assessment: Uses of Risk Analysis to Achieve Balanced Safety in Building Design and Operations National Research Council, Division on Engineering and Physical Sciences, Commission on Engineering and Technical Systems, Committee on Risk Appraisal in the Development of Facilities Design Criteria, 1991-02-01 This volume considers engineering risk analysis applications to the field of building safety. Building codes and design criteria used by architects and engineersâ€standards of good practice defined by industry consensusâ€have made great strides in bringing the dangers of facilities under control, but the range of hazards (e.g., fire, indoor air pollutants, electrical malfunctions) is broad. Risk analysis offers improved overall safety of new and existing facilities without imposing unacceptable costs. Broad application of risk analysis will help facility professionals, policymakers, and facility users and owners to understand the risks, to determine what levels of risk are socially and economically tolerable, and to manage risk more effectively. |
| benefits of risk assessment: Risk: A Very Short Introduction Baruch Fischhoff, John Kadvany, John David Kadvany, 2011-05-26 Risk is everywhere - from genetically modified crops, dams, and stem-cell therapy to heartbreak, online predators, inflation, and robbery. This Very Short Introduction examines what science has learned about how people deal with risks, what we can learn through decision theory, and how we can evaluate risk in our own lives. |
| benefits of risk assessment: Environmental and Health Risk Assessment and Management Paolo Ricci, 2006-01-27 This book is about the legal, economical, and practical assessment and management of risky activities arising from routine, catastrophic environmental and occupational exposures to hazardous agents. It includes a discussion of aspects of US and European Union law concerning risky activities, and then develops the economic analyses that are relevant to implementing choices within a supply and demand framework. The book also discusses exposure-response and time-series models used in assessing air and water pollution, as well as probabilistic cancer models, including toxicological compartmental, pharmaco-kinetic models and epidemiological relative risks and odds ratios-based models. Statistical methods to measure agreement, correlation and discordance are also developed. The methods and criteria of decision-analysis, including several measures of value of information (VOI) conclude the expositions. This book is an excellent text for students studying risk assessment and management. |
| benefits of risk assessment: Risk Assessment Methods V.T. Covello, M.W. Merkhoher, 2013-06-29 Much has already been written about risk assessment. Epidemiologists write books on how risk assessment is used to explore the factors that influence the distribution of disease in populations of people. Toxicologists write books on how risk assess ment involves exposing animals to risk agents and concluding from the results what risks people might experience if similarly exposed. Engineers write books on how risk assessment is utilized to estimate the risks of constructing a new facility such as a nuclear power plant. Statisticians write books on how risk assessment may be used to analyze mortality or accident data to determine risks. There are already many books on risk assessment-the trouble is that they all seem to be about different sUbjects! This book takes another approach. It brings together all the methods for assessing risk into a common framework, thus demonstrating how the various methods relate to one another. This produces four important benefits: • First, it provides a comprehensive reference for risk assessment. This one source offers readers concise explanations of the many methods currently available for describing and quantifying diverse types of risks. • Second, it consistently evaluates and compares available risk assessment methods and identifies their specific strengths and limitations. Understand ing the limitations of risk assessment methods is important. The field is still in its infancy, and the problems with available methods are disappoint ingly numerous. At the same time, risk assessment is being used. |
| benefits of risk assessment: A Safer Future National Research Council, Division on Earth and Life Studies, Commission on Geosciences, Environment and Resources, U.S. National Committee for the Decade for Natural Disaster Reduction, 1991-02-01 Initial priorities for U.S. participation in the International Decade for Natural Disaster Reduction, declared by the United Nations, are contained in this volume. It focuses on seven issues: hazard and risk assessment; awareness and education; mitigation; preparedness for emergency response; recovery and reconstruction; prediction and warning; learning from disasters; and U.S. participation internationally. The committee presents its philosophy of calls for broad public and private participation to reduce the toll of disasters. |
| benefits of risk assessment: The Owner's Role in Project Risk Management National Research Council, Division on Engineering and Physical Sciences, Board on Infrastructure and the Constructed Environment, Committee for Oversight and Assessment of U.S. Department of Energy Project Management, 2005-02-25 Effective risk management is essential for the success of large projects built and operated by the Department of Energy (DOE), particularly for the one-of-a-kind projects that characterize much of its mission. To enhance DOE's risk management efforts, the department asked the NRC to prepare a summary of the most effective practices used by leading owner organizations. The study's primary objective was to provide DOE project managers with a basic understanding of both the project owner's risk management role and effective oversight of those risk management activities delegated to contractors. |
| benefits of risk assessment: Assessment of Options for Extending the Life of the Hubble Space Telescope National Research Council, Division on Engineering and Physical Sciences, Aeronautics and Space Engineering Board, Space Studies Board, Committee on the Assessment of Options for Extending the Life of the Hubble Space Telescope, 2005-03-28 The Hubble Space Telescope (HST) has operated continuously since 1990. During that time, four space shuttle-based service missions were launched, three of which added major observational capabilities. A fifth †SM-4 †was intended to replace key telescope systems and install two new instruments. The loss of the space shuttle Columbia, however, resulted in a decision by NASA not to pursue the SM-4 mission leading to a likely end of Hubble's useful life in 2007-2008. This situation resulted in an unprecedented outcry from scientists and the public. As a result, NASA began to explore and develop a robotic servicing mission; and Congress directed NASA to request a study from the National Research Council (NRC) of the robotic and shuttle servicing options for extending the life of Hubble. This report presents an assessment of those two options. It provides an examination of the contributions made by Hubble and those likely as the result of a servicing mission, and a comparative analysis of the potential risk of the two options for servicing Hubble. The study concludes that the Shuttle option would be the most effective one for prolonging Hubble's productive life. |
| benefits of risk assessment: Five Steps to Risk Assessment HSE Books, Health and Safety Executive, 2006 Offers guidance for employers and self employed people in assessing risks in the workplace. This book is suitable for firms in the commercial, service and light industrial sectors. |
| benefits of risk assessment: Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget National Research Council, Division on Earth and Life Studies, Board on Environmental Studies and Toxicology, Committee to Review the OMB Risk Assessment Bulletin, 2007-04-16 Risk assessments are often used by the federal government to estimate the risk the public may face from such things as exposure to a chemical or the potential failure of an engineered structure, and they underlie many regulatory decisions. Last January, the White House Office of Management and Budget (OMB) issued a draft bulletin for all federal agencies, which included a new definition of risk assessment and proposed standards aimed at improving federal risk assessments. This National Research Council report, written at the request of OMB, evaluates the draft bulletin and supports its overall goals of improving the quality of risk assessments. However, the report concludes that the draft bulletin is fundamentally flawed from a scientific and technical standpoint and should be withdrawn. Problems include an overly broad definition of risk assessment in conflict with long-established concepts and practices, and an overly narrow definition of adverse health effects-one that considers only clinically apparent effects to be adverse, ignoring other biological changes that could lead to health effects. The report also criticizes the draft bulletin for focusing mainly on human health risk assessments while neglecting assessments of technology and engineered structures. |
| benefits of risk assessment: The Standard for Risk Management in Portfolios, Programs, and Projects Project Management Institute, 2019-04-22 This is an update and expansion upon PMI's popular reference, The Practice Standard for Project Risk Management. Risk Management addresses the fact that certain events or conditions may occur with impacts on project, program, and portfolio objectives. This standard will: identify the core principles for risk management; describe the fundamentals of risk management and the environment within which it is carried out; define the risk management life cycle; and apply risk management principles to the portfolio, program, and project domains within the context of an enterprise risk management approach It is primarily written for portfolio, program, and project managers, but is a useful tool for leaders and business consumers of risk management, and other stakeholders. |
| benefits of risk assessment: Public Participation in Environmental Assessment and Decision Making National Research Council, Division of Behavioral and Social Sciences and Education, Committee on the Human Dimensions of Global Change, Panel on Public Participation in Environmental Assessment and Decision Making, 2008-11-07 Federal agencies have taken steps to include the public in a wide range of environmental decisions. Although some form of public participation is often required by law, agencies usually have broad discretion about the extent of that involvement. Approaches vary widely, from holding public information-gathering meetings to forming advisory groups to actively including citizens in making and implementing decisions. Proponents of public participation argue that those who must live with the outcome of an environmental decision should have some influence on it. Critics maintain that public participation slows decision making and can lower its quality by including people unfamiliar with the science involved. This book concludes that, when done correctly, public participation improves the quality of federal agencies' decisions about the environment. Well-managed public involvement also increases the legitimacy of decisions in the eyes of those affected by them, which makes it more likely that the decisions will be implemented effectively. This book recommends that agencies recognize public participation as valuable to their objectives, not just as a formality required by the law. It details principles and approaches agencies can use to successfully involve the public. |
| benefits of risk assessment: Research Ethics in Africa Mariana Kruger, Paul Ndebele, Lyn Horn, 2014-06-01 The aim of this book is to provide research ethics committee members with a resource that focuses on research ethics issues in Africa. The authors are currently active in various aspects of research ethics in Africa and the majority have been trained in the past by either the Fogarty International Center or Europe and Developing Countries Clinical Trial Partnership (EDCTP) sponsored bioethics training programmes . |
| benefits of risk assessment: Review of the Department of Homeland Security's Approach to Risk Analysis National Research Council, Committee to Review the Department of Homeland Security's Approach to Risk Analysis, 2010-09-10 The events of September 11, 2001 changed perceptions, rearranged national priorities, and produced significant new government entities, including the U.S. Department of Homeland Security (DHS) created in 2003. While the principal mission of DHS is to lead efforts to secure the nation against those forces that wish to do harm, the department also has responsibilities in regard to preparation for and response to other hazards and disasters, such as floods, earthquakes, and other natural disasters. Whether in the context of preparedness, response or recovery from terrorism, illegal entry to the country, or natural disasters, DHS is committed to processes and methods that feature risk assessment as a critical component for making better-informed decisions. Review of the Department of Homeland Security's Approach to Risk Analysis explores how DHS is building its capabilities in risk analysis to inform decision making. The department uses risk analysis to inform decisions ranging from high-level policy choices to fine-scale protocols that guide the minute-by-minute actions of DHS employees. Although DHS is responsible for mitigating a range of threats, natural disasters, and pandemics, its risk analysis efforts are weighted heavily toward terrorism. In addition to assessing the capability of DHS risk analysis methods to support decision-making, the book evaluates the quality of the current approach to estimating risk and discusses how to improve current risk analysis procedures. Review of the Department of Homeland Security's Approach to Risk Analysis recommends that DHS continue to build its integrated risk management framework. It also suggests that the department improve the way models are developed and used and follow time-tested scientific practices, among other recommendations. |
| benefits of risk assessment: Integrated Cost-Schedule Risk Analysis Dr David Hulett, 2012-09-28 Project managers tend to believe their cost estimates - whether they have exceeded budgets in the past or not. It is dangerous to accept the engineering cost estimates, which are often optimistic or unrealistic. Though cost estimates incorporate contingency reserves below-the-line, these estimates of reserves often do not benefit from a rigorous assessment of risk to project costs. Risks to cost come from multiple sources including uncertain project duration, which is often ignored in cost risk analyses. In short, experience shows that cost estimating on projects is rarely successful - cost overruns routinely occur. There are effective ways to estimate the impact on the cost of complex projects from project risks of all types, including traditional cost-type risks and the indirect but often substantial impact from risks usually thought of as affecting project schedules. Integrated cost-schedule risk anlaysis helps us determine how likely the project will go over budget with the current plan, how much contingency reserve is required to achieve a desired level of certainty, and which risks are most important so the project manager can mitigate them and achieve a better result. Integrated Cost-Schedule Risk Analysis provides solutions for these and other challenges. This book follows on from David Hulett's highly-praised Practical Schedule Risk Analysis. It focuses on the way that schedule risk can generate cost risk, and how to handle this relationship. It also applies the Risk Driver Method to the analysis so that you can clearly and transparently identify the key risks, rather than just the most risky cost line items. With detailed worked examples and over 70 illustrations, Integrated Cost-Schedule Risk Analysis offers the definitive guide to this critically important aspect of project management from surely the world's leading commentator. |
| benefits of risk assessment: Agile Practice Guide , 2017-09-06 Agile Practice Guide – First Edition has been developed as a resource to understand, evaluate, and use agile and hybrid agile approaches. This practice guide provides guidance on when, where, and how to apply agile approaches and provides practical tools for practitioners and organizations wanting to increase agility. This practice guide is aligned with other PMI standards, including A Guide to the Project Management Body of Knowledge (PMBOK® Guide) – Sixth Edition, and was developed as the result of collaboration between the Project Management Institute and the Agile Alliance. |
| benefits of risk assessment: Risk Assessment and Management in Mental Health Nursing Phil Woods, Alyson M. Kettles, 2009-04-13 Risk assessment and management is a core element of mental health practice, and all nurses need to be aware of the risks surrounding them and their patients in order to create a safe working environment. This timely and accessible text explores how nurses can enhance their skills, and improve their practice so that risk is assessed and managed safely and effectively. Risk Assessment and Management in Mental Health Nursing explores issues including context and definitions of risk, risk assessment tools and techniques, strategies for preventing risk situations, suicide, self-harm, neglect, forensic aspects of risk, substance misuse, ethical considerations, , victimology, risk to others and risk to self. Special Features: Written in the context of latest policy developments such as the National Service Frameworks Discusses the role of the mental health nurse in the assessment and management of risk Explores an increasingly important and timely subject in mental health practice Practical focus, with case studies throughout Written by experts in the field |
| benefits of risk assessment: Risk Assessment and Management , 1984 |
| benefits of risk assessment: Continuous Risk Management Guidebook SOFTWARE ENGINEERING INSTITUTE AUTOR, JULIE E AUTOR WALKER, CHRISTOPHER J AUTOR ALBERTS, RONALD P AUTOR HIGUERA, 1996 |
| benefits of risk assessment: Communicating Risks and Benefits Baruch Fischhoff, 2012-03-08 Effective risk communication is essential to the well-being of any organization and those people who depend on it. Ineffective communication can cost lives, money and reputations. Communicating Risks and Benefits: An Evidence-Based User’s Guide provides the scientific foundations for effective communications. The book authoritatively summarizes the relevant research, draws out its implications for communication design, and provides practical ways to evaluate and improve communications for any decision involving risks and benefits. Topics include the communication of quantitative information and warnings, the roles of emotion and the news media, the effects of age and literacy, and tests of how well communications meet the organization’s goals. The guide will help users in any organization, with any budget, to make the science of their communications as sound as the science that they are communicating. |
| benefits of risk assessment: Ecological Risk Assessment Glenn W. Suter II, 1992-10-23 Recently, environmental scientists have been required to perform a new type of assessment-ecological risk assessment. This is the first book that explains how to perform ecological risk assessments and gives assessors access to the full range of useful data, models, and conceptual approaches they need to perform an accurate assessment. It explains how ecological risk assessment relates to more familiar types of assessments. It also shows how to organize and conduct an ecological risk assessment, including defining the source, selecting endpoints, describing the relevant features of the receiving environment, estimating exposure, estimating effects, characterizing the risks, and interacting with the risk manager. Specific technical topics include finding and selecting toxicity data; statistical and mathematical models of effects on organisms, populations, and ecosystems; estimation of chemical fate parameters; modeling of chemical transport and fate; estimation of chemical uptake by organisms; and estimation, propagation, and presentation of uncertainty. Ecological Risk Assessment also covers conventional risk assessments, risk assessments for existing contamination, large scale problems, exotic organisms, and risk assessments based on environmental monitoring. Environmental assessors at regulatory agencies, consulting firms, industry, and government labs need this book for its approaches and methods for ecological risk assessment. Professors in ecology and other environmental sciences will find the book's practical preparation useful for classroom instruction. Environmental toxicologists and chemists will appreciate the discussion of the utility for risk assessment of particular toxicity tests and chemical determinations. |
| benefits of risk assessment: Management of Risk , 2002 This guide is intended to help organisations put in place effective frameworks for taking informed decisions about risk. It brings together recommended approaches, checklists and pointers to more detailed information on tools and techniques. The topics covered include: the principles of risk management; how risks are managed; managing risks at the strategic, programme, project and operational level; techniques and examples of the benefits of risk management. The publication draws on the experience of experts from both the private and public sector. |
| benefits of risk assessment: Compliance Risk Assessments -- an Introduction Judith Spain, 2020-02 |
| benefits of risk assessment: Environmental Cleanup at Navy Facilities Committee on Environmental Remediation at Naval Facilities, 1999 The fiscal and technological limitations associated with cleaning up hazardous waste sites to background conditions have prompted responsible parties to turn to risk-based methods for environmental rememdiation. Environmental Cleanup at Navy Facilities reviews and critiques risk-based methods, including those developed by the U.S. Environmental Protection Agency and the American Society of Testing and Materials. These critiques lead to the identification of eleven criteria that must be part of any risk-based methodology adopted by the Navy, a responsible party with a large number of complex and heavily contaminated waste sites. January |
| benefits of risk assessment: International Ethical Guidelines for Health-Related Research Involving Humans Council for International Organizations of Medical Sciences (CIOMS), 2017-01-31 In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research.--Page 4 de la couverture. |
| benefits of risk assessment: Current Challenges in Pharmacovigilance World Health Organization, Council for International Organizations of Medical Sciences, Cioms, 2001-01-01 In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals. |
| benefits of risk assessment: Flood Risk Assessments Andrés Díez-Herrero, Julio Garrote, 2020-09-09 In recent years, a considerable volume of technical literature has been published on flood hazard analysis, and more recently, on flood vulnerability and resilience. Nevertheless, there is still a shortage of scientific studies and practical experience of real flood risk assessment (both social and economic), including hazard, exposure and vulnerability analyses and their integration. As there are so few references available, applications of flood risk assessment to the design of preventive measures and early warning systems, landscape and urban planning, civil protection, insurance systems, and risk-based information and education, cannot reach their full potential development. This is because the research products available, such as hazard data and maps, do not serve to ensure the efficient prioritization of mitigation measures or communities at risk. Meanwhile, flooding is the natural disaster that causes the greatest loss on a global scale, and due to climate change, this situation is expected to continue. The research manuscripts involved in this book try to offer flood risk managers new tools, data and maps to improve risk mitigation, both preventive and corrective. A wide variety of topics have been covered, including: flood risk data sources; techniques and methodologies for flood risk analysis; flood risk mapping; or flood risk analysis calibrations. |
| benefits of risk assessment: Embracing Risk, Enabling Choice , 2018 |
| benefits of risk assessment: Evidence-Based Pharmacovigilance Andrew Bate, 2018-10-26 This book examines insights into the latest thinking and core concepts in areas of key methodological endeavor in Pharmacovigilance (PV), which strives to ever more effectively protect patients from harm caused by the medicines they need. Each book chapter tends to have a clear quantitative or clinical slant and an aim to provide an overview of methodological insights within a specific topic, while also providing a perspective on how the area is anticipated to develop in the future. Quantitative chapters focus more on statistical and epidemiological strategies and the thinking that underpins core developments in Pharmacovigilance, whereas clinical chapters focus on clinical methods for detecting hypotheses for and determining side effects of medicinal products as well as misdiagnosis pitfalls. Examples of areas of importance include signal detection, risk management, and risk benefit assessment. Vital and authoritative, Evidence-Based Pharmacovigilance: Clinical and Quantitative Aspects aims to provide readers with a sense of the advances that have occurred in pharmacovigilance methods and approaches, as well as inspiration and motivation to advance the field of pharmacovigilance with a strong sense that there is much more work to be done in ensuring the safe use of medications by patients. |
| benefits of risk assessment: Benefit-Risk Assessment Methods in Medical Product Development Qi Jiang, Weili He, 2017-12-19 Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations. |
| benefits of risk assessment: CRISC Review Manual 6th Edition Isaca, 2016 |
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Guía a Benefits.gov para Seniors
Benefits.gov ofrece varias formas de buscar beneficios. Haga clic en la pestaña “Beneficios” y busque por categoría, estado o agencia federal para encontrar rápidamente los beneficios del …
Social Security Disabled Surviving Divorced Spouse Benefits
Social Security's Disabled Surviving Divorced Spouse's Benefits are federally funded and administered by the U.S. Social Security Administration (SSA). These benefits are paid to the …
Guía a Benefits.gov para las Familias
Benefits.gov puede ayudarle a saber cuáles beneficios usted pudiera recibir en caso de ser elegible y cómo solicitarlos. ¿Cómo puede ayudarle Benefits.gov? Usted trabaja duro y aun …
Celebrating Our Armed Forces - Benefits.gov
The Benefit Finder is a free, easy-to-use, confidential screening tool that helps determine eligibility for over 1,000 benefits. After completing the Benefit Finder questionnaire, you will be provided …
Social Security Retirement Insurance Benefits
This Social Security benefit is for eligible individuals who have earned enough Social Security credits and are at least age 62. Determine your eligibility for this benefit
State Crime Victims Compensation - Benefits.gov
The .gov means it's official Federal government websites always use a .gov or .mil domain. Before sharing sensitive information online, make sure you’re on a .gov or .mil site by inspecting your …
Bienvenidos a Benefits.gov | Benefits.Gov
Este sitio también está protegido por un certificado SSL (Secure Sockets Layer) que ha sido firmado por el gobierno de EE.UU. El https: // significa que todos los datos transmitidos están …
Programa Especial de Leche de North Carolina | Benefits.gov
Este sitio también está protegido por un certificado SSL (Secure Sockets Layer) que ha sido firmado por el gobierno de EE.UU. El https: // significa que todos los datos transmitidos están …
Welcome to Benefits.gov | Benefits.Gov
The Benefit Finder questionnaire can help you find benefits you may be eligible to receive and direct you to the agency to apply. Start Benefit Finder
Programa de Ayuda Individual y Familiar (IHP) - Benefits.gov
Este sitio también está protegido por un certificado SSL (Secure Sockets Layer) que ha sido firmado por el gobierno de EE.UU. El https: // significa que todos los datos transmitidos están …
Guía a Benefits.gov para Seniors
Benefits.gov ofrece varias formas de buscar beneficios. Haga clic en la pestaña “Beneficios” y busque por categoría, estado o agencia federal para encontrar rápidamente los beneficios del …
Social Security Disabled Surviving Divorced Spouse Benefits
Social Security's Disabled Surviving Divorced Spouse's Benefits are federally funded and administered by the U.S. Social Security Administration (SSA). These benefits are paid to the …
Guía a Benefits.gov para las Familias
Benefits.gov puede ayudarle a saber cuáles beneficios usted pudiera recibir en caso de ser elegible y cómo solicitarlos. ¿Cómo puede ayudarle Benefits.gov? Usted trabaja duro y aun …
Celebrating Our Armed Forces - Benefits.gov
The Benefit Finder is a free, easy-to-use, confidential screening tool that helps determine eligibility for over 1,000 benefits. After completing the Benefit Finder questionnaire, you will be provided …
