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 Science at EPA written by Mark R. Powell and published by Routledge. This book was released on 2014-04-23 with total page 469 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Regulation written by Jerry Brito and published by Mercatus Center at George Mason University. This book was released on 2012-08-13 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book The Pharmaceutical Regulatory Process written by Ira R. Berry and published by CRC Press. This book was released on 2008-12-02 with total page 492 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, an

Download or read book The Manipulation of Science and the Regulatory Process Affecting Oil and Gas Development in Alaska written by United States. Congress. House. Committee on Interior and Insular Affairs. Subcommittee on Water, Power, and Offshore Energy Resources and published by . This book was released on 1991 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Innovative Statistics in Regulatory Science written by Shein-Chung Chow and published by CRC Press. This book was released on 2019-11-14 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics in regulatory science are involved with the development of regulatory policy, guidance, and regulatory critical clinical initiatives related research. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are commonly encountered in regulatory science of pharmaceutical research and development including topics related to research activities, review of regulatory submissions, recent critical clinical initiatives, and policy/guidance development in regulatory science. Devoted entirely to discussing statistics in regulatory science for pharmaceutical development. Reviews critical issues (e.g., endpoint/margin selection and complex innovative design such as adaptive trial design) in the pharmaceutical development and regulatory approval process. Clarifies controversial statistical issues (e.g., hypothesis testing versus confidence interval approach, missing data/estimands, multiplicity, and Bayesian design and approach) in review/approval of regulatory submissions. Proposes innovative thinking regarding study designs and statistical methods (e.g., n-of-1 trial design, adaptive trial design, and probability monitoring procedure for sample size) for rare disease drug development. Provides insight regarding current regulatory clinical initiatives (e.g., precision/personalized medicine, biomarker-driven target clinical trials, model informed drug development, big data analytics, and real world data/evidence). This book provides key statistical concepts, innovative designs, and analysis methods that are useful in regulatory science. Also included are some practical, challenging, and controversial issues that are commonly seen in the review and approval process of regulatory submissions. About the author Shein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Cambridge, MA, Executive Director at Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers Squibb, Plainsboro, NJ. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Biostatistics Book Series, Chapman and Hall/CRC Press, Taylor & Francis, New York. Dr. Chow is the author or co-author of over 300 methodology papers and 30 books.

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 with total page 235 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 Risk Assessment in the Federal Government written by National Research Council and published by National Academies Press. This book was released on 1983-02-01 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Research Regulatory Compliance written by Mark A. Suckow and published by Academic Press. This book was released on 2015-06-14 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users for the deluge of regulatory and compliance issues they will face while conducting their scientific programs. The book is edited and authored by known leaders in the field of compliance and regulations, and contains extensive research on the topics. It represents the new standard for information in every laboratory. - Provides a "one-stop" , go-to resource for the many regulatory and compliance issues that affect laboratory study and research models - Extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and also a great asset for faculty or new researchers coming in to the laboratory environment - Focuses on United States regulations, covering both animal models and human subjects - Written and edited by known leaders in the field of regulatory compliance who bring many years of collective experience to the book

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 Functions and Processes of the Regulatory Body for Safety written by International Atomic Energy Agency and published by . This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Safety Guide provides recommendations on meeting the requirements of IAEA Safety Standards Series No. GSR Part 1 (Rev. 1), Governmental, Legal and Regulatory Framework for Safety, on the regulatory body's core functions and associated regulatory processes. This guidance is particularly important for regulatory bodies having responsibilities covering a range of facilities and activities that give rise to radiation risks and the important organizational interfaces between various regulatory authorities, which require effective coordination and cooperation. It promotes a consistent approach to regulation and specifically addresses the release of facilities and activities from regulatory control including sites, buildings, equipment and material. The publication is intended to be used mainly by regulatory bodies but will also be useful for governments that are developing a regulatory framework for safety. It will also assist authorized parties and others dealing with radiation sources in understanding regulatory procedures, processes and expectations.

Download or read book Management of Animal Care and Use Programs in Research Education and Testing written by Robert H. Weichbrod and published by CRC Press. This book was released on 2017-09-07 with total page 917 pages. Available in PDF, EPUB and Kindle. Book excerpt: AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all types of programs involving animal care and use. The new edition has more than doubled the number of chapters in the original volume to present a more comprehensive overview of the current breadth and depth of the field with applicability to an international audience. Readers are provided with the latest information and resource and reference material from authors who are noted experts in their field. The book: - Emphasizes the importance of developing a collaborative culture of care within an animal care and use program and provides information about how behavioral management through animal training can play an integral role in a veterinary health program - Provides a new section on Environment and Housing, containing chapters that focus on management considerations of housing and enrichment delineated by species - Expands coverage of regulatory oversight and compliance, assessment, and assurance issues and processes, including a greater discussion of globalization and harmonizing cultural and regulatory issues - Includes more in-depth treatment throughout the book of critical topics in program management, physical plant, animal health, and husbandry. Biomedical research using animals requires administrators and managers who are knowledgeable and highly skilled. They must adapt to the complexity of rapidly-changing technologies, balance research goals with a thorough understanding of regulatory requirements and guidelines, and know how to work with a multi-generational, multi-cultural workforce. This book is the ideal resource for these professionals. It also serves as an indispensable resource text for certification exams and credentialing boards for a multitude of professional societies Co-publishers on the second edition are: ACLAM (American College of Laboratory Animal Medicine); ECLAM (European College of Laboratory Animal Medicine); IACLAM (International Colleges of Laboratory Animal Medicine); JCLAM (Japanese College of Laboratory Animal Medicine); KCLAM (Korean College of Laboratory Animal Medicine); CALAS (Canadian Association of Laboratory Animal Medicine); LAMA (Laboratory Animal Management Association); and IAT (Institute of Animal Technology).

Download or read book The Fifth Branch written by Sheila Jasanoff and published by Harvard University Press. This book was released on 1998-08-19 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Download or read book Preventing Regulatory Capture written by Daniel Carpenter and published by Cambridge University Press. This book was released on 2014 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: Leading scholars from across the social sciences present empirical evidence that the obstacle of regulatory capture is more surmountable than previously thought.

Download or read book The Politics of Regulatory Reform written by Stuart Shapiro and published by Routledge. This book was released on 2014-01-21 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulation has become a front-page topic recently, often referenced by politicians in conjunction with the current state of the U.S. economy. Yet despite regulation’s increased presence in current politics and media, The Politics of Regulatory Reform argues that the regulatory process and its influence on the economy is misunderstood by the general public as well as by many politicians. In this book, two experienced regulation scholars confront questions relevant to both academic scholars and those with a general interest in ascertaining the effects and importance of regulation. How does regulation impact the economy? What roles do politicians play in making regulatory decisions? Why do politicians enact laws that require regulations and then try to hamper agencies abilities to issue those same regulations? The authors answer these questions and untangle the misperceptions behind regulation by using an area of regulatory policy that has been underutilized until now. Rather than focusing on the federal government, Shapiro and Borie-Holtz have gathered a unique dataset on the regulatory process and output in the United States. They use state-specific data from twenty-eight states, as well as a series of case studies on regulatory reform, to question widespread impressions and ideas about the regulatory process. The result is an incisive and comprehensive study of the relationship between politics and regulation that also encompasses the effects of regulation and the reasons why regulatory reforms are enacted.