Download or read book The Regulatory Environment for Science written by and published by . This book was released on 1986 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Regulatory environment for science written by United States. Congress. Office of Technology Assessment and published by DIANE Publishing. This book was released on 1986 with total page 139 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Regulatory Environment for Science written by and published by . This book was released on 1986 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Science and the Regulatory Environment written by United States. Congress. House. Committee on Science and Technology. Task Force on Science Policy and published by . This book was released on 1986 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Science Policy Task Force Report written by Stephen J. Heinig and published by . This book was released on 1990 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Regulatory Environment for Science written by and published by . This book was released on 1986 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Regulatory Environment written by Reem K. Al-Essa and published by Springer. This book was released on 2015-05-06 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-04 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Biotechnology Research in an Age of Terrorism written by National Research Council and published by National Academies Press. This book was released on 2004-03-02 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years much has happened to justify an examination of biological research in light of national security concerns. The destructive application of biotechnology research includes activities such as spreading common pathogens or transforming them into even more lethal forms. Policymakers and the scientific community at large must put forth a vigorous and immediate response to this challenge. This new book by the National Research Council recommends that the government expand existing regulations and rely on self-governance by scientists rather than adopt intrusive new policies. One key recommendation of the report is that the government should not attempt to regulate scientific publishing but should trust scientists and journals to screen their papers for security risks, a task some journals have already taken up. With biological information and tools widely distributed, regulating only U.S. researchers would have little effect. A new International Forum on Biosecurity should encourage the adoption of similar measures around the world. Seven types of risky studies would require approval by the Institutional Biosafety Committees that already oversee recombinant DNA research at some 400 U.S. institutions. These "experiments of concern" include making an infectious agent more lethal and rendering vaccines powerless.
Download or read book Institutions and Incentives in Regulatory Science written by Jason Scott Johnston and published by Lexington Books. This book was released on 2012-04-12 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Models in Environmental Regulatory Decision Making written by National Research Council and published by National Academies Press. This book was released on 2007-08-25 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many regulations issued by the U.S. Environmental Protection Agency (EPA) are based on the results of computer models. Models help EPA explain environmental phenomena in settings where direct observations are limited or unavailable, and anticipate the effects of agency policies on the environment, human health and the economy. Given the critical role played by models, the EPA asked the National Research Council to assess scientific issues related to the agency's selection and use of models in its decisions. The book recommends a series of guidelines and principles for improving agency models and decision-making processes. The centerpiece of the book's recommended vision is a life-cycle approach to model evaluation which includes peer review, corroboration of results, and other activities. This will enhance the agency's ability to respond to requirements from a 2001 law on information quality and improve policy development and implementation.
Download or read book The Legal and Regulatory Environment of Business written by Robert Neil Corley and published by McGraw-Hill Companies. This book was released on 1996 with total page 776 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Optimizing the Nation s Investment in Academic Research written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-06-29 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research universities are critical contributors to our national research enterprise. They are the principal source of a world-class labor force and fundamental discoveries that enhance our lives and the lives of others around the world. These institutions help to create an educated citizenry capable of making informed and crucial choices as participants in a democratic society. However many are concerned that the unintended cumulative effect of federal regulations undercuts the productivity of the research enterprise and diminishes the return on the federal investment in research. Optimizing the Nation's Investment in Academic Research reviews the regulatory framework as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. This review is critical to strengthen the partnership between the federal government and research institutions, to maximize the creation of new knowledge and products, to provide for the effective training and education of the next generation of scholars and workers, and to optimize the return on the federal investment in research for the benefit of the American people.
Download or read book Environmental Regulation written by Robert V. Percival and published by Aspen Publishers. This book was released on 2000 with total page 1302 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Keeping Pace with Science and Engineering written by National Academy of Engineering and published by National Academies Press. This book was released on 1993-02-01 with total page 293 pages. Available in PDF, EPUB and Kindle. Book excerpt: The technical basis of environmental regulation is always at the edge of scientific and engineering understanding. As knowledge improves, questions will inevitably arise about past decisions. Understanding how the regulatory system accommodates changing scientific and engineering knowledge is vital for achieving environmental values. In this new volume, seven case studies shed light on the interplay between environmental regulation and scientific and engineering understanding, with practical conclusions on how science and engineering should be used for more sound and timely regulatory decision making. The book provides helpful timelines of scientific and regulatory developments for the cases, which include: Factors impeding clean-up strategies in the Chesapeake Bay. Pivotal questions in the regulation of ambient ozone concentrations. How science has been heeded but also ignored in regulation of new municipal waste combustors. Impact of scientific findings on control of chlorination by-products. Acid rain and what can be learned about research and public policy debate. Controversy over the need for formaldehyde regulation. The effect of public perception on management decisions concerning dioxin. This volume will be of practical interest to policymakers, business and environmental advocates, scientists, engineers, researchers, attorneys, faculty, and students.
Download or read book Law Technology and Society written by Roger Brownsword and published by Routledge. This book was released on 2019-02-18 with total page 327 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
