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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.
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.
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.
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
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.
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.
Animals are widely used in neuroscience research to explore biological mechanisms of nervous system function, to identify the genetic basis of disease states, and to provide models of human disorders and diseases for the development of new treatments. To ensure the humane care and use of animals, numerous laws, policies, and regulations are in place governing the use of animals in research, and certain animal regulations have implications specific to neuroscience research. To consider animal research regulations from a global perspective, the IOM Forum on Neuroscience and Nervous System Disorders, in collaboration with the National Research Council and the Institute for Laboratory Animal Research, held a workshop in Buckinghamshire, UK, July 26-27, 2011. The workshop brought together neuroscientists, legal scholars, administrators, and other key stakeholders to discuss current and emerging trends in animal regulations as they apply to the neurosciences. This document summarizes the workshop.
Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
Federal regulations affect nearly every area of our lives and interest in them is increasing. However, many people have no idea how regulations are developed or how they have an impact on our lives. Regulation: A Primer by Susan Dudley and Jerry Brito provides an accessible overview of regulatory theory, analysis, and practice. The Primer examines the constitutional underpinnings of federal regulation and discusses who writes and enforces regulation and how they do it. Published by the Mercatus Center at George Mason University, it also provides insights into the different varieties of regulation and how to analyze whether a regulatory proposal makes citizens better or worse off. Each chapter discusses key aspects of regulation and provides further readings for those interested in exploring these topics in more detail.