Risk Analysis and Governance in EU Policy Making and Regulation

An Introductory Guide

Author: Bernardo Delogu

Publisher: Springer

ISBN: 331930822X

Category: Political Science

Page: 288

View: 3335

This book provides an easy, but comprehensive and rigorous access to the main concepts, terminology, methods and procedures of risk analysis intended for all those involved in the EU policy and regulatory decision making on risks. It establishes a common ground of knowledge which enables a more informed dialogue on risks, a closer collaboration between decision makers and scientists and a better appraisal of the potential and limits of risk science. The book also brings together in an accessible way much multidisciplinary knowledge which had been dispersed over many technical documents and specialist books. The EU is in the front line of health, safety and environmental risk management. GMOs, food safety, hazardous chemicals, climate change, radiation hazards, are just a few of the popular risk issues addressed by the EU through policy and regulatory measures. The risk analysis paradigm, including risk assessment, management and communication has been at the core of the EU decision making for a long time already. EU Institutions strive for a science-based approach to risk management. Nevertheless, the dialogue and collaboration on risk issues between policy makers, stakeholders and scientists are still difficult and the potential and limits of science in support of decision making, as well as the basic concepts of risk analysis are not fully understood outside the narrow specialist circles.

Governing Public Health

EU Law, Regulation and Biopolitics

Author: Mark Flear

Publisher: Bloomsbury Publishing

ISBN: 1782259740

Category: Law

Page: 304

View: 496

This book contributes towards EU studies and the growing discourse on law and public health. It uses the EU's governance of public health as a lens through which to explore questions of legal competence and its development through policy and concrete techniques, processes and practices, risk and security, human rights and bioethics, accountability and legitimacy, democracy and citizenship, and the nature, essence and 'future trajectory' of the European integration project. These issues are explored first by situating the EU's public health strategy within the overarching architecture of governance and subsequently by examining its operationalisation in relation to the key public health problems of cancer, HIV/AIDS and pandemic planning. The book argues that the centrality and valorisation of scientific and technical knowledge and expertise in the EU's risk-based governance means that citizen participation in decision-making is largely marginalised and underdeveloped ? and that this must change if public health and the quality, accountability and legitimacy of EU governance and its regulation are to be improved. Subsequently the book goes on to argue that the legitimating discourses of ethics and human rights, and the developing notion of EU (supra-)stewardship responsibility, can help to highlight the normative dimensions of governance and its interventions in public health. These discourses and dimensions provide openings and possibilities for citizens to power 'technologies of participation' and contribute important supplementary knowledge to decision-making.

The Role of ‘Experts' in International and European Decision-Making Processes

Advisors, Decision Makers or Irrelevant Actors?

Author: Monika Ambrus,Karin Arts,Ellen Hey,Helena Raulus

Publisher: Cambridge University Press

ISBN: 1316062058

Category: Law

Page: N.A

View: 7607

Experts are increasingly relied on in decision-making processes at international and European levels. Their involvement in those processes, however, is contested. This timely book on the role of 'experts' provides a broad-gauged analysis of the issues raised by their involvement in decision-making processes. The chapters explore three main recurring themes: the rationales for involving experts and ensuing legitimacy problems; the individual and collective dimensions of expert involvement in decision making; and experts and politics and the politics of expertise. With contributions from leading scholars and practitioners, they theorize the experts' involvement in general and address their role in the policy areas of environment, trade, human rights, migration, financial regulation, and agencification in the European Union.

Risk Assessment of Chemicals: An Introduction

Author: C.J. van Leeuwen,T.G. Vermeire

Publisher: Springer Science & Business Media

ISBN: 1402061021

Category: Science

Page: 686

View: 3395

At last – a second edition of this hugely important text that reflects the progress and experience gained in the last decade and aims at providing background and training material for a new generation of risk assessors. The authors offer an introduction to risk assessment of chemicals as well as basic background information on sources, emissions, distribution and fate processes for the estimation of exposure of plant and animal species in the environment and humans exposed via the environment, consumer products, and at the workplace. The coverage describes the basic principles and methods of risk assessment within their legislative frameworks (EU, USA, Japan and Canada).

EU Environmental Law, Governance and Decision-Making

Author: Maria Lee

Publisher: Bloomsbury Publishing

ISBN: 1782254080

Category: Law

Page: 273

View: 9127

A vast and diverse body of EU law addresses an enormous range of environmental matters. This book examines a number of areas of substantive EU environmental law, focusing on the striking preoccupation of EU environmental law with the structure of decision-making. It highlights the observation that environmental protection and environmental decision-making depend intimately on both detailed, specialised information about the physical state of the world, and on political judgments about values and priorities. It also explores the elaborate mechanisms that attempt to bring these distinctive decision-making resources into EU environmental law in areas including industrial pollution, chemicals regulation, environmental assessment and climate change.

The Precautionary Principle in EU Risk Regulation

A Matter of Priorities

Author: Barbara Berthoud

Publisher: Anchor Academic Publishing (aap_verlag)

ISBN: 3954897202

Category: Political Science

Page: 84

View: 4627

The precautionary principle provides a justification to act where scientific uncertainty about the nature and extent of detected indications of harm would otherwise possibly impede regulatory interventions. The highly controversial and often misunderstood principle plays a central role in European risk regulation. The present volume should allow readers to gain an overview of all essential points linked with the role of the principle in the risk regulation framework of the European Union. Based on an outline of the precautionary principle’s main characteristics and its conception by the European Commission, common allegations brought against the principle are illuminated and critically assessed. The second part of the book is then devoted to the actual implementation of the principle in the EU – from early applications to ongoing disputes. Three case studies from the agrochemical, pharmaceutical and food packaging sector reflect current applications as well as the relevant institutional and procedural framework. Insights from the theoretical part and the case studies are melted in the final discussion section that also includes recommendations for EU risk regulators.

Handbook of Regulatory Impact Assessment

Author: Claire A. Dunlop,Claudio M. Radaelli

Publisher: Edward Elgar Publishing

ISBN: 1782549560

Category: Political Science

Page: 512

View: 4292

Regulatory impact assessment (RIA) is the main instrument used by governments and regulators to appraise the likely effects of their policy proposals. This pioneering Handbook provides a comparative and comprehensive account of this tool, situating it in the relevant theoretical traditions and scrutinizing its use across countries, policy sectors and policy instruments. Comprising six parts, university researchers, international consultants and practitioners working in international organizations examine regulatory impact assessment from many perspectives, which include: • research traditions in the social sciences • implementation, regulatory indicators and effects • tools and dimensions such as courts and gender • sectoral case studies including environment, enterprise and international development • international diffusion in the European Union (EU), Americas, Asia and developing countries • appraisal, training and education. With its wealth of detail and lessons to be learned, the Handbook of Regulatory Impact Assessment will undoubtedly be of great value to practitioners and scholars working in governance, political science and socio-legal studies.

Global Risk Governance

Concept and Practice Using the IRGC Framework

Author: Ortwin Renn,Katherine D. Walker

Publisher: Springer Science & Business Media

ISBN: 9781402067990

Category: Technology & Engineering

Page: 370

View: 9012

The establishment of the International Risk Governance Council (IRGC) was the direct result of widespread concern that the complexity and interdependence of health, environmental, and technological risks facing the world was making the development and implementation of adequate risk governance strategies ever more difficult. This volume details the IRGC developed and proposed framework for risk governance and covers how it was peer reviewed as well as tested

PRAGMATIC Security Metrics

Applying Metametrics to Information Security

Author: W. Krag Brotby,Gary Hinson

Publisher: CRC Press

ISBN: 1439881537

Category: Business & Economics

Page: 512

View: 8484

Other books on information security metrics discuss number theory and statistics in academic terms. Light on mathematics and heavy on utility, PRAGMATIC Security Metrics: Applying Metametrics to Information Security breaks the mold. This is the ultimate how-to-do-it guide for security metrics. Packed with time-saving tips, the book offers easy-to-follow guidance for those struggling with security metrics. Step by step, it clearly explains how to specify, develop, use, and maintain an information security measurement system (a comprehensive suite of metrics) to help: Security professionals systematically improve information security, demonstrate the value they are adding, and gain management support for the things that need to be done Management address previously unsolvable problems rationally, making critical decisions such as resource allocation and prioritization of security relative to other business activities Stakeholders, both within and outside the organization, be assured that information security is being competently managed The PRAGMATIC approach lets you hone in on your problem areas and identify the few metrics that will generate real business value. The book: Helps you figure out exactly what needs to be measured, how to measure it, and most importantly, why it needs to be measured Scores and ranks more than 150 candidate security metrics to demonstrate the value of the PRAGMATIC method Highlights security metrics that are widely used and recommended, yet turn out to be rather poor in practice Describes innovative and flexible measurement approaches such as capability maturity metrics with continuous scales Explains how to minimize both measurement and security risks using complementary metrics for greater assurance in critical areas such as governance and compliance In addition to its obvious utility in the information security realm, the PRAGMATIC approach, introduced for the first time in this book, has broader application across diverse fields of management including finance, human resources, engineering, and production—in fact any area that suffers a surplus of data but a deficit of useful information. Visit Security Metametrics. Security Metametrics supports the global community of professionals adopting the innovative techniques laid out in PRAGMATIC Security Metrics. If you, too, are struggling to make much sense of security metrics, or searching for better metrics to manage and improve information security, Security Metametrics is the place. http://securitymetametrics.com/

Genetically Modified Organisms in Developing Countries

Risk Analysis and Governance

Author: Ademola A. Adenle,E. Jane Morris,Denis J. Murphy

Publisher: Cambridge University Press

ISBN: 1108239137

Category: Medical

Page: N.A

View: 8153

Bringing together the ideas of experts from around the world, this incisive text offers cutting-edge perspectives on the risk analysis and governance of genetically modified organisms (GMOs), supporting effective and informed decision-making in developing countries. Comprised of four comprehensive sections, this book covers: integrated risk analysis and decision making, giving an overview of the science involved and examining risk analysis methods that impact decision-making on the release of GMOs, particularly in developing countries; diversification of expertise involved in risk analysis and practical ways in which the lack of expertise in developing countries can be overcome; risk analysis based regulatory systems and how they can be undermined by power relationships and socio-political interests, as well as strategies for improving GMO policy development and regulatory decision-making; and case studies from developing countries providing lessons based on real-world experience that can inform our current thinking.

Experimentalist Governance in the European Union

Towards a New Architecture

Author: Charles F. Sabel,Jonathan Zeitlin

Publisher: OUP Oxford

ISBN: 0191610186

Category: Political Science

Page: 386

View: 9244

This book advances a novel interpretation of EU governance. Its central claim is that the EU's regulatory successes within-and increasingly beyond-its borders rest on the emergence of a recursive process of framework rule making and revision by European and national actors across a wide range of policy domains. In this architecture, framework goals and measures for gauging their achievement are established by joint action of the Member States and EU institutions. Lower-level units are given the freedom to advance these ends as they see fit. But in return for this autonomy, they must report regularly on their performance and participate in a peer review in which their results are compared with those of others pursuing different means to the same general ends. The framework goals, performance measures, and decision-making procedures are themselves periodically revised by the actors, including new participants whose views come to be seen as indispensable to full and fair deliberation. The editors' introduction sets out the core features of this experimentalist architecture and contrasts it to conventional interpretations of EU governance, especially the principal-agent conceptions underpinning many contemporary theories of democratic sovereignty and effective, legitimate law making. Subsequent chapters by an interdisciplinary group of European and North American scholars explore the architecture's applicability across a series of key policy domains, including data privacy, financial market regulation, energy, competition, food safety, GMOs, environmental protection, anti-discrimination, fundamental rights, justice and home affairs, and external relations. Their authoritative studies show both how recent developments often take an experimentalist turn but also admit of multiple, contrasting interpretations or leave open the possibility of reversion to more familiar types of governance. The results will be indispensable for all those concerned with the nature of the EU and its contribution to contemporary governance beyond the nation-state.

Post-Crisis Banking Regulation in the European Union

Opportunities and Threats

Author: Katarzyna Sum

Publisher: Springer

ISBN: 3319413783

Category: Business & Economics

Page: 260

View: 6354

This book offers holistic, economic analysis of the on-going regulatory reform in the European banking industry. The author addresses the main opportunities and pitfalls related to post-crisis financial regulation, and investigates whether the proposed solutions provide an appropriate response to the problems within the EU’s ailing banking sector. The author gives particular focus to the implementation of Basel III, the introduction of the Banking Union, the inclusion of bank governance elements into regulatory frameworks, and the country-specific aspects of regulation at a national level. The discussion builds upon existing literature in the field and takes a novel approach in its examination of banking regulations, their endogeneity and their interactions with bank governance. The book also analyses banking regulation in the EU within theoretical frameworks, as well as by means of empirical exercises. Insights into the theory and practical aspects of banking regulation make this book a valuable read for academics, researchers, students and practitioners alike.

Benefit-Risk Assessment Methods in Medical Product Development

Bridging Qualitative and Quantitative Assessments

Author: Qi Jiang,Weili He

Publisher: CRC Press

ISBN: 1482259370

Category: Mathematics

Page: 296

View: 6341

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.

Everything You Always Wanted to Know about European Union Health Policies But Were Afraid to Ask

Author: S. L. Greer,Who Regional Office for Europe

Publisher: N.A

ISBN: 9789289050272

Category: Law

Page: 160

View: 5174

The EU's health mandate allows for a comprehensive set of public health actions, and there are other EU policies, though not health related, which have important consequences for governing, financing, staffing and delivering health services. In other words: EU actions affect the health of Europe's population and the performance of health systems. Given the importance of health systems, an informed debate on the role of the EU and its contribution is required. This though is not easy because EU health policy is difficult to comprehend. There is no single strategy with a neat body of legislation implementing it; rather, there are many different objectives and instruments, some of which appear in unlikely places. Understanding the EU's role in health is especially important now with health systems having to deal with a plethora of challenges including the European financial crisis and the growth of euro-scepticism in politics. This short book aims to makes EU health policy accessible to the political and technical debate, the volume focusing on four aspects of EU health policy: (i) the EU institutions, processes and powers related to health; (ii) the EU action taken on the basis of this health mandate; (iii) the non-health action affecting health and health systems; and, because of its growing importance, financial governance and what it means for European health systems.

Heat-Health Action Plans


Author: Franziska Matthies,Graham Bickler,Neus Cardeñosa Marin

Publisher: World Health Organization

ISBN: 9289071915

Category: Medical

Page: 45

View: 3196

Climate change is leading to variations in weather patterns and an apparent increase in extreme weather events, including heat-waves. Recent heat-waves in the WHO European Region have led to a rise in related mortality but the adverse health effects of hot weather and heat-waves are largely preventable. Prevention requires a portfolio of actions at different levels, including meteorological early warning systems, timely public and medical advice, improvements to housing and urban planning and ensuring that health care and social systems are ready to act. These actions can be integrated into a defined heat-health action plan. This guidance results from the EuroHEAT project on improving public health responses to extreme weather/heat-waves, co-funded by WHO and the European Commission. It explains the importance of the development of heat-health action plans, their characteristics and core elements, with examples from several European countries that have begun their implementation and evaluation.

Managing Risk in Nanotechnology

Topics in Governance, Assurance and Transfer

Author: Finbarr Murphy,Eamonn M. McAlea,Martin Mullins

Publisher: Springer

ISBN: 331932392X

Category: Business & Economics

Page: 240

View: 3849

This book aims to address how nanotechnology risks are being addressed by scientists, particularly in the areas of human health and the environment and how these risks can be measured in financial terms for insurers and regulators. It provides a comprehensive overview of nanotechnology risk measurement and risk transfer methods, including a chapter outlining how Bayesian methods can be used. It also examines nanotechnology from a legal perspective, both current and potential future outcomes. The global market for nanotechnology products was valued at $22.9 billion in 2013 and increased to about $26 billion in 2014. This market is expected to reach about $64.2 billion by 2019, a compound annual growth rate (CAGR) of 19.8% from 2014 to 2019. Despite the increasing value of nanotechnologies and their widespread use, there is a significant gap between the enthusiasm of scientists and nanotechnology entrepreneurs working in the nanotechnology space and the insurance/regulatory sector. Scientists are scarcely aware that insurers/regulators have concerns about the potential for human and environmental risk and insurers/regulators are not in a position to access the potential risk. This book aims to bridge this gap by defining the current challenges in nanotechnology across disciplines and providing a number of risk management and assessment methodologies. Featuring contributions from authors in areas such as regulation, law, ethics, management, insurance and manufacturing, this volume provides an interdisciplinary perspective that is of value to students, academics, researchers, policy makers, practitioners and society in general.

Regulating Pharmaceuticals In Europe: Striving For Efficiency, Equity And Quality

Striving for Efficiency, Equity and Quality

Author: Mossialos, Elias,Mrazek, Monique,Walley, Tom

Publisher: McGraw-Hill Education (UK)

ISBN: 0335226558

Category: Education

Page: 390

View: 2863

The rising cost of pharmaceutical expenditures in many European countries is of concern to governments required to make effective use of health care budgets. Taking a broad perspective that encompasses institutional, political and supranational aspects of pharmaceutical regulation, this book examines approaches used to manage pharmaceutical expenditure across Europe and what impact these strategies have had on efficiency, quality, equity and cost of pharmaceutical care. Regulating Pharmaceuticals in Europe is an important book for students of health policy, regulation and management, and for health managers and policy makers.

Extending Experimentalist Governance?

The European Union and Transnational Regulation

Author: Jonathan Zeitlin

Publisher: Oxford University Press, USA

ISBN: 0198724500

Category: Law

Page: 410

View: 7359

"Earleir versions of the chapters were discussed at workshops at the University of Wisconsin-Madison in 2009 and at the University of Amsterdam in 2012"--page v.

Toxicological Risk Assessment of Chemicals

A Practical Guide

Author: Elsa Nielsen,Grete Ostergaard,John Christian Larsen

Publisher: CRC Press

ISBN: 9781420006940

Category: Medical

Page: 448

View: 8098

Unlike many existing books on toxicology that cover either toxicity of a particular substance or toxicity of chemicals on particular organ systems, Toxicological Risk Assessment of Chemicals: A Practical Guide lays out the principle activities of conducting a toxicological risk assessment, including international approaches and methods for the risk assessment of chemical substances. It illustrates each step in the process: hazard identification, a dose response assessment, and exposure assessment. The book also summarizes the basic concepts of interaction of chemicals in mixtures and discusses various approaches to testing such mixtures. Features: Addresses standards from all international regulatory agencies Presents the steps in risk assessment, including hazard identification, exposure assessment, and risk characterization Covers the assessment of multiple chemical exposures or chemical mixtures Contains data from both human and animal studies Explains the linearized multi-stage mathematical model widely used by the US EPA for characterizing