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Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309222176
Category : Medical
Languages : en
Pages : 118
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Book Description
The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309222176
Category : Medical
Languages : en
Pages : 118
Get Book Here
Book Description
The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
Author: Robert Neil Corley
Publisher: McGraw-Hill Companies
ISBN:
Category : Law
Languages : en
Pages : 776
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Book Description
Upon its publication in 1963, Corley's Legal Environment of Business was the first and only business law textbook to emphasize public rather than private law, government regulation of business rather than contracts, and legal relationships rather than business transactions. A major innovation, it established a new course that the authors termed the legal environment of business. Over the years others have attempted to attain the success and stature of The Legal and Regulatory Environment of Business, but none has been able to match its timely, innovative coverage. Substantially updated, the 10th edition continues the text's reputation for ethics, authority and coverage of current areas of importance to business.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309120462
Category : Political Science
Languages : en
Pages : 422
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Book Description
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.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498635
Category : Medical
Languages : en
Pages : 169
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Book Description
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Author: Jason Scott Johnston
Publisher: Lexington Books
ISBN: 0739169467
Category : Law
Languages : en
Pages : 235
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Book Description
Institutions and Incentives in Regulatory Science explores fundamental problems with regulatory science in the environmental and natural resource law field. Each chapter covers a variety of natural resource and regulatory areas, ranging from climate change to endangered species protection and traditional health-based environmental regulation. Regulatory laws and institutions themselves strongly influence the direction of scientific research by creating a system of rewards and penalties for science. As a consequence, regulatory laws or institutions that are designed naively end up incentivizing scientists to generate and then publish only those results that further the substantive regulatory goals preferred by the scientists. By relying so heavily on science to dictate policy, regulatory laws and institutions encourage scientists to use their assessment of the state of the science to further their own preferred scientific and regulatory policy agendas. Additionally, many environmental and natural resource regulatory agencies have been instructed by legislatures to rely heavily upon science in their rulemaking. In areas of rapidly evolving science, regulatory agencies are inevitably looking for scientific consensus prematurely, before the scientific process has worked through competing hypotheses and evidence. The contributors in this volume address how institutions for regulatory science should be designed in light of the inevitable misfit between the political or legal demand for regulatory action and the actual state of evolving scientific knowledge.
Author: Reem K. Al-Essa
Publisher: Springer
ISBN: 3319175904
Category : Medical
Languages : en
Pages : 246
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Book Description
This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients’ access to new medicines. The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.
Author: Mark R. Powell
Publisher: Routledge
ISBN: 1134271697
Category : Nature
Languages : en
Pages : 469
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Book Description
The U.S. Environmental Protection Agency was created to protect public health and the environment, and it has traditionally emphasized its regulatory mission over its scientific mission. Yet for environmental policy to be credible with the public and policymakers, EPA's actions must have a sound basis in science. In Science at EPA, Mark Powell offers detailed case studies that map the origins, flow, and impact of scientific information in eight EPA decisions involving the agency's major statutory programs. Drawing on extensive research and interviews, he provides the most comprehensive examination available on the acquisition and use of science in environmental regulation. Powell describes the key obstacles to the practical, efficient, and effective acquisition and use of knowledge in what is a crucial, but complex endeavor. His book is an essential contribution for practitioners, scholars and students, and citizens who are determined to protect our environment rationally and effectively.
Author: Robert V. Percival
Publisher: Aspen Publishers
ISBN:
Category : Law
Languages : en
Pages : 1302
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Book Description
In its refined Third Edition, this popular casebook responds to both changes in the field and user feedback. ENVIRONMENTAL REGULATION: Law, Science, and Policy, Third Edition, Is skillfully designed to help students and professors navigate this complex area of law. The authors bring clarity and coherence To The study of environmental regulations And The policy considerations that shape them, with: comprehensive coverage that supplies a complete introduction to environmental law while it allows professors flexibility to choose which topics to emphasize a detailed examination of policy that goes beyond an explanation of the regulatory structure to explore the political, economic, and ethical concerns that influence policy and enforcement effective teaching and study aids including charts and diagrams that map the structure of each major environmental statute, problems and questions based on real-life situations, and 'pathfinders' to explain where to locate crucial source materials a website (http://www.law.umaryland.edu/courses/environment) that continually updates subjects covered in the book with links that enable students to learn more about topics of interest detailed suggestions for teaching from the book provided in an extensive Teacher's Manual engaging and student-friendly text that demystifies the field Updated features of ENVIRONMENTAL REGULATION: Law, Science, and Policy, Third Edition, include: Updated coverage of the Clean Air Act New chapter on Land Use Regulation and Regulatory Policy Broader coverage of issues of federalism and congressional authority New problem exercises, and cases, including the Supreme Court's year 2000 Laidlaw decision on standing in citizen enforcement actions When you select materials for your next course, consider the book that provides you with the most recent information and lets you organize it to suit your individual teaching preferences - ENVIRONMENTAL REGULATION: Law, Science, and Policy, Third Edition. Authors' website: http://www.law.umaryland.edu/courses/environment
Author: Roger Brownsword
Publisher: Routledge
ISBN: 1351128167
Category : Law
Languages : en
Pages : 327
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Book Description
This book considers the implications of the regulatory burden being borne increasingly by technological management rather than by rules of law. If crime is controlled, if human health and safety are secured, if the environment is protected, not by rules but by measures of technological management—designed into products, processes, places and so on—what should we make of this transformation? In an era of smart regulatory technologies, how should we understand the ‘regulatory environment’, and the ‘complexion’ of its regulatory signals? How does technological management sit with the Rule of Law and with the traditional ideals of legality, legal coherence, and respect for liberty, human rights and human dignity? What is the future for the rules of criminal law, torts and contract law—are they likely to be rendered redundant? How are human informational interests to be specified and protected? Can traditional rules of law survive not only the emergent use of technological management but also a risk management mentality that pervades the collective engagement with new technologies? Even if technological management is effective, is it acceptable? Are we ready for rule by technology? Undertaking a radical examination of the disruptive effects of technology on the law and the legal mind-set, Roger Brownsword calls for a triple act of re-imagination: first, re-imagining legal rules as one element of a larger regulatory environment of which technological management is also a part; secondly, re-imagining the Rule of Law as a constraint on the arbitrary exercise of power (whether exercised through rules or through technological measures); and, thirdly, re-imagining the future of traditional rules of criminal law, tort law, and contract law.
Author: Sheila Jasanoff
Publisher: Harvard University Press
ISBN: 9780674039117
Category : Political Science
Languages : en
Pages : 322
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Book Description
How can decisionmakers charged with protecting the environment and the public's health and safety steer clear of false and misleading scientific research? Is it possible to give scientists a stronger voice in regulatory processes without yielding too much control over policy, and how can this be harmonized with democratic values? These are just some of the many controversial and timely questions that Sheila Jasanoff asks in this study of the way science advisers shape federal policy. In their expanding role as advisers, scientists have emerged as a formidable fifth branch of government. But even though the growing dependence of regulatory agencies on scientific and technical information has granted scientists a greater influence on public policy, opinions differ as to how those contributions should be balanced against other policy concerns. More important, who should define what counts as good science when all scientific claims incorporate social factors and are subject to negotiation? Jasanoff begins by describing some significant failures--such as nitrites, Love Canal, and alar--in administrative and judicial decisionmaking that fed the demand for more peer review of regulatory science. In analyzing the nature of scientific claims and methods used in policy decisions, she draws comparisons with the promises and limitations of peer review in scientific organizations operating outside the regulatory context. The discussion of advisory mechanisms draws on the author's close scrutiny of two highly visible federal agencies--the Environmental Protection Agency and the Food and Drug Administration. Here we see the experts in action as they deliberate on critical issues such as clean air, pesticide regulation, and the safety of pharmaceuticals and food additives. Jasanoff deftly merges legal and institutional analysis with social studies of science and presents a strong case for procedural reforms. In so doing, she articulates a social-construction model that is intended to buttress the effectiveness of the fifth branch.
