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| duke regulatory affairs training program: Building the Clinical Research Workforce: Challenges, Capacities and Competencies Carolynn Thomas Jones, Barbara E. Bierer, Stephen Sonstein, Hazel Ann Smith, Denise Snyder, 2024-08-05 This is an unprecedented time for clinical research. The number and complexity of clinical research studies have increased significantly in the last decade. Individual participation in clinical research broadened, with an increase in diverse populations, diseases, and geographic settings. The successful execution of these studies, however, has been compromised by an international shortage of clinical research professionals, coupled with an appreciation of the growing number of core competencies necessary for performance. Developed over a decade ago, the Joint Task Force for Clinical Trial Competency (JTF) Framework outlines the knowledge, skills and attitudes that are essential for the safe and effective conduct of a clinical study. This framework has been used to develop professional pathways, trainings, and certification programs and has been extended internationally through translation. |
| duke regulatory affairs training program: Ethical and Regulatory Aspects of Clinical Research Ezekiel J. Emanuel, 2003 Professionals in need of such training and bioethicists will be interested. |
| duke regulatory affairs training program: A Clinical Trials Manual From The Duke Clinical Research Institute Margaret Liu, Kate Davis, 2011-08-24 The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity. —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical nuts and bolts approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites. |
| duke regulatory affairs training program: An Introduction to Autopsy Technique Kim A. Collins, Grover M. Hutchins, 2005-01-01 Partial Contents: Introduction to Autopsy Techniques; Before the Dissection; The Complete Autopsy: Procedures With the Body Present; Dissecting the Organ Block; After the Dissection; Perinatal and Pediatric Autopsies; The Placenta; Restricted Autopsies; Embalmed Bodies; Special Techniques. |
| duke regulatory affairs training program: Envisioning a Transformed Clinical Trials Enterprise in the United States Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2012-09-13 There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop. |
| duke regulatory affairs training program: Enforcement of the U.S. Department of Veterans Affairs' Brachytherapy Program Safety Standards United States. Congress. House. Committee on Veterans' Affairs. Subcommittee on Oversight and Investigations, 2009 |
| duke regulatory affairs training program: Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2012-04-04 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. |
| duke regulatory affairs training program: The Politics of Policies Ernesto Stein, 2005 This study analyzes how the workings of the policymaking process affect the quality of policy outcomes. It looks beyond a purely technocratic approach, arguing that the political and policymaking processes are inseparable. It offers a wide variety of examples and case studies, and yields useful insights for the design of effective policy reform. |
| duke regulatory affairs training program: Occupational Health and Safety in the Care and Use of Research Animals National Research Council, Commission on Life Sciences, Institute for Laboratory Animal Research, Committee on Occupational Safety and Health in Research Animal Facilities, 1997-07-09 Much has been written about the care of research animals. Yet little guidance has appeared on protecting the health and safety of the people who care for or use these animals. This book, an implementation handbook and companion to Guide For the Care and Use of Laboratory Animals, identifies principles for building a program and discusses the accountability of institutional leaders, managers, and employees for a program's success. It provides a detailed description of risksâ€physical and chemical hazards, allergens and zoonoses, and hazards from experimentsâ€which will serve as a continuing reference for the laboratory. The book offers specific recommendations for controlling risk through administrative procedures, facility design, engineering controls, and periodic evaluations. The volume focuses on the worker, with detailed discussions of work practices, the use of personal protective gear, and the development of an emergency response plan. This handbook will be invaluable to administrators, researchers, and employees in any animal research facility. It will also be of interest to personnel in zoos, animal shelters, and veterinary facilities. |
| duke regulatory affairs training program: Weekly Information Report , 1999-10 |
| duke regulatory affairs training program: History on the Run Ma Vang, 2020-12-21 During its secret war in Laos (1961–1975), the United States recruited proxy soldiers among the Hmong people. Following the war, many of these Hmong soldiers migrated to the United States with refugee status. In History on the Run Ma Vang examines the experiences of Hmong refugees in the United States to theorize refugee histories and secrecy, in particular those of the Hmong. Vang conceptualizes these histories as fugitive histories, as they move and are carried by people who move. Charting the incomplete archives of the war made secret through redacted US state documents, ethnography, film, and literature, Vang shows how Hmong refugees tell their stories in ways that exist separately from narratives of U.S. empire and that cannot be traditionally archived. In so doing, Vang outlines a methodology for writing histories that foreground refugee epistemologies despite systematic attempts to silence those histories. |
| duke regulatory affairs training program: The Comprehensive Guide To Clinical Research Chris Sauber, Dan Sfera, 2019-04-21 Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps |
| duke regulatory affairs training program: Registries for Evaluating Patient Outcomes Agency for Healthcare Research and Quality/AHRQ, 2014-04-01 This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. |
| duke regulatory affairs training program: Accelerated Materials Discovery Phil De Luna, 2022-02-21 Typical timelines to go from discovery to impact in the advanced materials sector are between 10 to 30 years. Advances in robotics and artificial intelligence are poised to accelerate the discovery and development of new materials dramatically. This book is a primer for any materials scientist looking to future-proof their careers and get ahead of the disruption that artificial intelligence and robotic automation is just starting to unleash. It is meant to be an overview of how we can use these disruptive technologies to augment and supercharge our abilities to discover new materials that will solve world’s biggest challenges. Written by world leading experts on accelerated materials discovery from academia (UC Berkeley, Caltech, UBC, Cornell, etc.), industry (Toyota Research Institute, Citrine Informatics) and national labs (National Research Council of Canada, Lawrence Berkeley National Labs). |
| duke regulatory affairs training program: Evolution of Translational Omics Institute of Medicine, Board on Health Sciences Policy, Board on Health Care Services, Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials, 2012-09-13 Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials. |
| duke regulatory affairs training program: Real-World Evidence Generation and Evaluation of Therapeutics National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2017-07-05 The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop. |
| duke regulatory affairs training program: Cardiac Reconstructions with Allograft Tissues Richard A. Hopkins, 2005-11-12 Cryopreserved allograft tissues are now standard materials for the reconstructive cardiac surgeon. Since publication of the first edition (Cardiac Reconstructions with Allograft Valves) in 1989, the field has progressed dramatically with increased clinical use of cardiovascular allograft tissues, with the development of new surgical techniques, and with advances in the understanding of the fundamentals of valve transplantation biology and cryopreservation. As a result, over two-thirds of the present volume represents new material. Fifty-six authors bring their expertise to thirteen comprehensive, lavishly illustrated sections which discuss the principles of the use of homograft valves, major clinical series of homograft valves for both left and right ventricular outflow tracts, cryopreserved allograft tissue for cardiac reconstruction, cell biology of heart valve leaflets, cryobiology of heart valve preservation, morphological, biochemical, and explant pathology studies of allograft heart valves, allograft valve banking, as well as detailed explanation of surgical techniques for valve and root methods for left and right ventricular outflow tract reconstructions, the Ross operation and variants, and complex reconstructions. A final section presents potential future directions for the field. Over 400 illustrations, created expressly for this book, depict the surgical techniques from the perspective of the surgeon standing at the operating table. All surgeons performing pediatric and/or adult valve replacements and reconstructive cardiac surgeries will benefit from the described methods. Cardiothoracic residents and cardiologists will also find the text useful. It will provide the surgeon with an enhanced understanding of the biological and material properties of allografts and increased familiarity with the range of surgical techniques applicable for the use of these valves, particularly in the successful management of challenging cardiac reconstructions.> |
| duke regulatory affairs training program: The Last Muslim Conquest Gábor Ágoston, 2023-09-12 A monumental work of history that reveals the Ottoman dynasty's important role in the emergence of early modern Europe The Ottomans have long been viewed as despots who conquered through sheer military might, and whose dynasty was peripheral to those of Europe. The Last Muslim Conquest transforms our understanding of the Ottoman Empire, showing how Ottoman statecraft was far more pragmatic and sophisticated than previously acknowledged, and how the Ottoman dynasty was a crucial player in the power struggles of early modern Europe. In this panoramic and multifaceted book, Gábor Ágoston captures the grand sweep of Ottoman history, from the dynasty's stunning rise to power at the turn of the fourteenth century to the Siege of Vienna in 1683, which ended Ottoman incursions into central Europe. He discusses how the Ottoman wars of conquest gave rise to the imperial rivalry with the Habsburgs, and brings vividly to life the intrigues of sultans, kings, popes, and spies. Ágoston examines the subtler methods of Ottoman conquest, such as dynastic marriages and the incorporation of conquered peoples into the Ottoman administration, and argues that while the Ottoman Empire was shaped by Turkish, Iranian, and Islamic influences, it was also an integral part of Europe and was, in many ways, a European empire. Rich in narrative detail, The Last Muslim Conquest looks at Ottoman military capabilities, frontier management, law, diplomacy, and intelligence, offering new perspectives on the gradual shift in power between the Ottomans and their European rivals and reframing the old story of Ottoman decline. |
| duke regulatory affairs training program: Polish Cinema Today Helena Goscilo, Beth Holmgren, 2021-08-19 A 2022 Choice Reviews Outstanding Academic Title Structured according to key themes, Polish Cinema Today analyzes the remarkable innovations in Polish cinema emerging a decade after the 1989 dissolution of the Soviet bloc, once its film industry had evolved from a socialist state enterprise into a much more accessible system of film production, with growing expertise in distribution and marketing. By the early 2000s, an impressive, diverse cohort of filmmakers broke through the gridlock of a small set of esteemed, aging auteurs as well as the glut of imported Hollywood blockbusters, empowered by the digital revolution and domestic audience appetite for independent work. Polish directors today challenge sacrosanct bromides about national and gender identity, Poland’s historical martyrdom, the status of the influential Catholic Church, and the benevolent family, while investigating the phenomena of migration and sexuality in their full complexity. Each thematic chapter places these recent films within a historical/cultural context nationally and transnationally, and designs its analyses of specific works to engage general audiences of film scholars, students, and cinephiles. |
| duke regulatory affairs training program: Human Rights in Colombian Literature and Cultural Production Carlos Gardeazábal Bravo, Kevin G. Guerrieri, 2022-04-28 This volume explores how Colombian novelists, artists, performers, activists, musicians, and others seek to enact—to perform, to stage, to represent—human rights situations that are otherwise enacted discursively, that is, made public or official, in juridical and political realms in which justice often remains an illusory or promised future. In order to probe how cultural production embodies the tensions between the abstract universality of human rights and the materiality of violations on individual human bodies and on determined groups, the volume asks the following questions: How does the transmission of historical traumas of Colombia’s past, through human rights narratives in various forms, inform the debates around the subjects of rights, truth and memory, remembrance and forgetting, and the construction of citizenship through solidarity and collective struggles for justice? What are the different roles taken by cultural products in the interstices among rights, laws, and social justice within different contexts of state violence and states of exception? What are alternative perspectives, sources, and (micro)histories from Colombia of the creation, evolution, and practice of human rights? How does the human rights discourse interface with notions of environmental justice, especially in the face of global climate change, regional (neo)extractivism, the implementation of megaprojects, and ongoing post-accord thefts and (re)appropriations of land? Through a wide range of disciplinary lenses, the different chapters explore counter-hegemonic concepts of human rights, decolonial options struggling against oppression and market logic, and alternative discourses of human dignity and emancipation within the pluriverse. |
| duke regulatory affairs training program: Title List of Documents Made Publicly Available , 1982 |
| duke regulatory affairs training program: International Regulatory Harmonization Amid Globalization of Drug Development Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2013-11-24 The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop. |
| duke regulatory affairs training program: Dream Hoarders Richard Reeves, 2018-05-08 Dream Hoarders sparked a national conversation on the dangerous separation between the upper middle class and everyone else. Now in paperback and newly updated for the age of Trump, Brookings Institution senior fellow Richard Reeves is continuing to challenge the class system in America. In America, everyone knows that the top 1 percent are the villains. The rest of us, the 99 percent—we are the good guys. Not so, argues Reeves. The real class divide is not between the upper class and the upper middle class: it is between the upper middle class and everyone else. The separation of the upper middle class from everyone else is both economic and social, and the practice of “opportunity hoarding”—gaining exclusive access to scarce resources—is especially prevalent among parents who want to perpetuate privilege to the benefit of their children. While many families believe this is just good parenting, it is actually hurting others by reducing their chances of securing these opportunities. There is a glass floor created for each affluent child helped by his or her wealthy, stable family. That glass floor is a glass ceiling for another child. Throughout Dream Hoarders, Reeves explores the creation and perpetuation of opportunity hoarding, and what should be done to stop it, including controversial solutions such as ending legacy admissions to school. He offers specific steps toward reducing inequality and asks the upper middle class to pay for it. Convinced of their merit, members of the upper middle class believes they are entitled to those tax breaks and hoarded opportunities. After all, they aren't the 1 percent. The national obsession with the super rich allows the upper middle class to convince themselves that they are just like the rest of America. In Dream Hoarders, Reeves argues that in many ways, they are worse, and that changes in policy and social conscience are the only way to fix the broken system. |
| duke regulatory affairs training program: Contagious Priscilla Wald, 2008-01-09 DIVShows how narratives of contagion structure communities of belonging and how the lessons of these narratives are incorporated into sociological theories of cultural transmission and community formation./div |
| duke regulatory affairs training program: Administrative Law and Regulatory Policy Stephen G. Breyer, Michael Herz, Richard B. Stewart, Cass R. Sunstein, Adrian Vermeule, 2022-04-19 The ninth edition of this classic casebook Administrative Law and Regulatory Policy: Problems, Text, and Cases is streamlined and updated while retaining the previous editions’ rigor, comprehensiveness, and contextual approach. Outstanding authorship, rich and varied materials, and comprehensive coverage remain the hallmarks of the ninth edition of the acclaimed Administrative Law and Regulatory Policy: Problems, Text, and Cases. Administrative procedure is examined in the context of substantive policy debates regarding regulation in a wide range of areas. Extensive notes, questions, and problems support thoughtful reading and analysis. The presentation acknowledges complexity and contradictions in the material while still providing explanations and guideposts along the way. Problems interspersed throughout provide an opportunity to explore the doctrine in more depth and test one’s understanding of it. New to the Ninth Edition: A thorough updating of cases, notes, and questions A more streamlined and user-friendly presentation. Despite significant additions, the 9th edition is shorter than the 8th. Inclusion of important recent judicial decisions, including Gundy v. United States, 139 S. Ct. 2116 (2019) (nondelegation) Lucia v. SEC, 138 S. Ct. 2044 (2018) (officers of the U.S.) Seila Law LLC v. CFPB, 140 S. Ct. 2183 (2020) (president’s removal authority) Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, 138 S. Ct. 1365 (2018) (agency adjudication) Kisor v. Wilkie, 139 S. Ct. 2400 (2019) (deference to an agency’s interpretation of its own regulation) DHS v. Regents of the University of California, 140 S. Ct. 1891 (2020) (DACA rescission) Department of Commerce v. State of New York, 139 S. Ct. 2551 (2019) (pretextual justifications and arbitrary and capricious review) Little Sisters of the Poor v. Pennsylvania, 140 S. Ct. 2367 (2020) (interim final rulemaking) Professors and students will benefit from: Thorough coverage of the processes of agency rulemaking and adjudication Illuminating discussion of doctrines that may be on the cusp of major change, including Chevron deference, Auer deference, and the nondelegation doctrine Attention to the underlying justifications for, and possible criticisms of, the regulatory initiatives that are the subject of the cases studied. Extensive notes and questions that both explain and challenge A completely new website that provides Additional materials for possible assignment (including an introductory case study and materials on enforcement) Illustrative agency documents (rulemaking preambles, an administrative complaint, FOIA requests and denials, etc.) Extensive links to material on the web, including on agency websites, that provide examples of or help students situate the topics in the casebook Photographs of people, places, and things that are the subject of the cases in the book Updates on new decisions, statutes, and regulatory initiatives |
| duke regulatory affairs training program: NIH Almanac National Institutes of Health (U.S.). Division of Public Information, |
| duke regulatory affairs training program: The Role of NIH in Drug Development Innovation and Its Impact on Patient Access National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Board on Health Care Services, 2020-01-27 To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop. |
| duke regulatory affairs training program: Sludge Cass R. Sunstein, 2021-09-07 How we became so burdened by red tape and unnecessary paperwork, and why we must do better. We've all had to fight our way through administrative sludge--filling out complicated online forms, mailing in paperwork, standing in line at the motor vehicle registry. This kind of red tape is a nuisance, but, as Cass Sunstein shows in Sludge, it can also also impair health, reduce growth, entrench poverty, and exacerbate inequality. Confronted by sludge, people just give up--and lose a promised outcome: a visa, a job, a permit, an educational opportunity, necessary medical help. In this lively and entertaining look at the terribleness of sludge, Sunstein explains what we can do to reduce it. Because of sludge, Sunstein, explains, too many people don't receive benefits to which they are entitled. Sludge even prevents many people from exercising their constitutional rights--when, for example, barriers to voting in an election are too high. (A Sludge Reduction Act would be a Voting Rights Act.) Sunstein takes readers on a tour of the not-so-wonderful world of sludge, describes justifications for certain kinds of sludge, and proposes Sludge Audits as a way to measure the effects of sludge. On balance, Sunstein argues, sludge infringes on human dignity, making people feel that their time and even their lives don't matter. We must do better. |
| duke regulatory affairs training program: Hong Kong Takes Flight John D. Wong, Associate Professor of Hong Kong Studies John D Wong, 2022-08-30 Commercial aviation took shape in Hong Kong as the city developed into a powerful economy. In Hong Kong Takes Flight, John Wong argues that Hong Kong's development into a regional and global airline hub was not preordained and views the city's globalization through the prism of its airline industry. |
| duke regulatory affairs training program: Transforming Clinical Research in the United States Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2010-10-22 An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise. |
| duke regulatory affairs training program: Situating Spirituality Brian Steensland, Jaime Kucinskas, Anna Sun, 2021 Spirituality is in the spotlight. While levels of religious belief and observance are declining in much of the Western world, interest in spirituality is surging. This volume advances our understanding of contemporary spirituality by highlighting its profoundly social dimensions. It demonstrates how spirituality is shaped by its religious, cultural, and political contexts; how embodied and collective spiritual practices undergird spiritual life and intersect with social characteristics (e.g., race, gender, and sexuality); and how spirituality is impacted by power relations and institutional arrangements. The contributors are leading international scholars and their chapters address spirituality in a wide range of religious and global contexts-- |
| duke regulatory affairs training program: Compromise Jack Knight, 2018-05-22 The problem of clean hands : negotiated compromise in lawmaking / Eric Beerbohm -- Which side are you on? / Anton Ford -- The moral distinctiveness of legislated law / David Dyzenhaus -- On compromise, negotiation, and loss / Amy J. Cohen -- Compromise in negotiation / Simon Cábulea May -- Uncompromising democracy / Melissa Schwartzberg -- Democratic conflict and the political morality of compromise / Michelle M. Moody-Adams -- The challenges of conscience in a world of compromise / Amy J. Sepinwall -- Necessary compromise and public harm / Andrew Sabl -- Compromise and representative government : a skeptical perspective / Alexander Kirshner. |
| duke regulatory affairs training program: Peterson's Annual Guides to Graduate Study Peterson's Guides, Inc, 1983 |
| duke regulatory affairs training program: Quality and Safety in Women's Health Thomas Ivester, 2018-04-05 Designed for all providers of women's healthcare - including those undertaking Maintenance of Certification programs, trainees preparing for postgraduate examinations, and those initiating or growing a program of quality improvement and patient safety - this practical manual guides those implementing QI and safety programs with specific emphasis on Obstetrics and Gynecology practice. The content contains a strong case-based element to improve accessibility and understanding. An introductory section covers core attributes needed by all physicians to build a culture of patient safety, including leadership, communication and QI skills. Core clinical skills are then reviewed - in a variety of labor ward, office, operating room, and outpatient settings. Finally systems implications are highlighted, including information transparency and disclosure, training programs, and regulatory and legal implications. The editors are involved with national and international initiatives educating physicians in safety aspects of practice. The book is published in collaboration with the Foundation for EXXcellence. |
| duke regulatory affairs training program: SCAI Interventional Cardiology Review Morton J. Kern, Arnold H. Seto, 2024-10-02 Keep current with recent changes in the field and prepare for certification or recertification with SCAI Interventional Cardiology Review, Fourth Edition. Edited by Drs. Morton J. Kern and Arnold H. Seto, and written by global experts who are Society for Cardiovascular Angiography and Interventions (SCAI) members and leaders, coverage includes all topics on the interventional cardiology board exam and revised information throughout. |
| duke regulatory affairs training program: A Century of Innovation 3M Company, 2002 A compilation of 3M voices, memories, facts and experiences from the company's first 100 years. |
| duke regulatory affairs training program: The Hacked World Order Adam Segal, 2016-02-23 For more than three hundred years, the world wrestled with conflicts that arose between nation-states. Nation-states wielded military force, financial pressure, and diplomatic persuasion to create world order. Even after the end of the Cold War, the elements comprising world order remained essentially unchanged. But 2012 marked a transformation in geopolitics and the tactics of both the established powers and smaller entities looking to challenge the international community. That year, the US government revealed its involvement in Operation Olympic Games, a mission aimed at disrupting the Iranian nuclear program through cyberattacks; Russia and China conducted massive cyber-espionage operations; and the world split over the governance of the Internet. Cyberspace became a battlefield. Cyber conflict is hard to track, often delivered by proxies, and has outcomes that are hard to gauge. It demands that the rules of engagement be completely reworked and all the old niceties of diplomacy be recast. Many of the critical resources of statecraft are now in the hands of the private sector, giant technology companies in particular. In this new world order, cybersecurity expert Adam Segal reveals, power has been well and truly hacked. |
| duke regulatory affairs training program: Virtual Clinical Trials National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2019-11-16 Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop. |
| duke regulatory affairs training program: Capitalism and Democracy Thomas A. Spragens, Jr., 2021-03-01 This book serves as an introduction to the ongoing political debate about the relationship of capitalism and democracy. In recent years, the ideological battles between advocates of free markets and minimal government, on the one hand, and adherents of greater democratic equality and some form of the welfare state, on the other hand, have returned in full force. Anyone who wants to make sense of contemporary American politics and policy battles needs to have some understanding of the divergent beliefs and goals that animate this debate. In Capitalism and Democracy, Thomas A. Spragens, Jr., examines the opposing sides of the free market versus welfare state debate through the lenses of political economy, moral philosophy, and political theory. He asks: Do unchecked markets maximize prosperity, or do they at times produce wasteful and damaging outcomes? Are market distributions morally appropriate, or does fairness require some form of redistribution? Would a society of free markets and minimal government be the best kind of society possible, or would it have serious problems? After leading the reader through a series of thought experiments designed to compare and clarify the thought processes and beliefs held by supporters of each side, Spragens explains why there are no definitive answers to these questions. He concludes, however, that some answers are better than others, and he explains why his own judgement is that a vigorous free marketplace provides great benefits to a democratic society, both economically and politically, but that it also requires regulation and supplementation by collective action for a society to maximize prosperity, to mitigate some of the unfairness of the human condition, and to be faithful to important democratic purposes and ideals. This engaging and accessible book will interest students and scholars of political economy, democratic theory, and theories of social justice. It will also appeal to general readers who are seeking greater clarity and understanding of contemporary debates about government's role in the economy. |
| duke regulatory affairs training program: Measuring Social Welfare Matthew D. Adler, 2019 Disputes over government policies rage in a number of areas. From taxation to climate change, from public finance to risk regulation, and from health care to infrastructure planning, advocates debate how policies affect multiple dimensions of individual well-being, how these effects balance against each other, and how trade-offs between overall well-being and inequality should be resolved. How to measure and balance well-being gains and losses is a vexed issue. Matthew D. Adler advances the debate by introducing the social welfare function (SWF) framework and demonstrating how it can be used as a powerful tool for evaluating governmental policies. The framework originates in welfare economics and in philosophical scholarship regarding individual well-being, ethics, and distributive justice. It has three core components: a well-being measure, which translates each of the possible policy outcomes into an array of interpersonally comparable well-being numbers, quantifying how well off each person in the population would be in that outcome; a rule for ranking outcomes thus described; and an uncertainty module, which orders policies understood as probability distributions over outcomes. The SWF framework is a significant improvement compared to cost-benefit analysis (CBA), which quantifies policy impacts in dollars, is thereby biased towards the rich, and is insensitive to the distribution of these monetized impacts. The SWF framework, by contrast, uses an unbiased measure of well-being and allows the policymaker to consider both efficiency (total well-being) and equity (the distribution of well-being). Because the SWF framework is a fully generic methodology for policy assessment, Adler also discusses how it can be implemented to inform government policies. He illustrates it through a detailed case study of risk regulation, contrasting the implications of results of SWF and CBA. This book provides an accessible, yet rigorous overview of the SWF approach that can inform policy-makers and students. |
常春藤、25所新常春藤、公立常春藤都是哪些学校？ - 知乎
知乎，中文互联网高质量的问答社区和创作者聚集的原创内容平台，于 2011 年 1 月正式上线，以「让人们更好的分享知识、经验和见解，找到自己的解答」为品牌使命。知乎凭借认真、专业、友善的社区 …
能否介绍一下数学界的期刊？ - 知乎
T1: Duke Math, Annales Sci l'ENS, JEMS, CPAM, GAFA T2: JMPA, Proc London, AMJ, TAMS, Math Ann, Crelle Journal, Compositio, Adv Math, Selecta Math 此外还有发表长文章的 MAMS, MSMF, …
英伟达 RTX 5060 Ti 正式开售，国行售价 3199 元起，这代 60Ti
Apr 17, 2025 · 知乎，中文互联网高质量的问答社区和创作者聚集的原创内容平台，于 2011 年 1 月正式上线，以「让人们更好的分享知识、经验和见解，找到自己的解答」为品牌使命。知乎凭借认真、专 …
如何合理的检索外文参考文献的出版地和出版商？ - 知乎
我的毕业论文参考文献中有大量的[sl]和[sn]标志,前者是表示出版地未知，后者是表示出版商未知，我需要高…
北卡罗莱纳州（North Carolina）在美国是怎样的存在？ - 知乎
北卡大学质量在美国名列前茅，杜克大学排名第8，Wake第27，UNC-CH第30，Davidson在Liberal Arts College里排第十一，而以前一直在前十。Duke，UNC和NC State组成了triangle，当中的科学园 …
英国的英格兰、北爱尔兰、苏格兰、威尔士到底是什么关系？ - 知乎
1967年，伊丽莎白二世访问法国诺曼底地区，诺曼底当地的农民见到女王后便脱帽行礼，说“Vive la Duchesse”（法语：女公爵万岁！），当时女王回复说“Well, I am the Duke of Normandy!（我是诺 …
上海有什么特产比较方便携带？ - 知乎
知乎，中文互联网高质量的问答社区和创作者聚集的原创内容平台，于 2011 年 1 月正式上线，以「让人们更好的分享知识、经验和见解，找到自己的解答」为品牌使命。知乎凭借认真、专业、友善的社区 …
东北大学在985里什么水平？ - 知乎
当然你东去美国不错，听说88能上duke ece（虽然duke cs方面不是很强但是牌子好啊），也有一位上了ucb的牛人。说明牢美还是有几把刷子，狠狠认可。不过老美金币爆的确实有些多了，嗯就难评。 我 …
常春藤、25所新常春藤、公立常春藤都是哪些学校？ - 知乎
知乎，中文互联网高质量的问答社区和创作者聚集的原创内容平台，于 2011 年 1 月正式上线，以「让人们更好的分享知识、经验和见解，找到自己的解答」为品牌使命。知乎凭借认真、专业 …
能否介绍一下数学界的期刊？ - 知乎
T1: Duke Math, Annales Sci l'ENS, JEMS, CPAM, GAFA T2: JMPA, Proc London, AMJ, TAMS, Math Ann, Crelle Journal, Compositio, Adv Math, Selecta Math 此外还有发表长文章的 MAMS, …
英伟达 RTX 5060 Ti 正式开售，国行售价 3199 元起，这代 60Ti 值 …
Apr 17, 2025 · 知乎，中文互联网高质量的问答社区和创作者聚集的原创内容平台，于 2011 年 1 月正式上线，以「让人们更好的分享知识、经验和见解，找到自己的解答」为品牌使命。知乎 …
如何合理的检索外文参考文献的出版地和出版商？ - 知乎
我的毕业论文参考文献中有大量的[sl]和[sn]标志,前者是表示出版地未知，后者是表示出版商未知，我需要高…
北卡罗莱纳州（North Carolina）在美国是怎样的存在？ - 知乎
北卡大学质量在美国名列前茅，杜克大学排名第8，Wake第27，UNC-CH第30，Davidson在Liberal Arts College里排第十一，而以前一直在前十。Duke，UNC和NC State组成了triangle，当中的 …
英国的英格兰、北爱尔兰、苏格兰、威尔士到底是什么关系？ - 知乎
1967年，伊丽莎白二世访问法国诺曼底地区，诺曼底当地的农民见到女王后便脱帽行礼，说“Vive la Duchesse”（法语：女公爵万岁！），当时女王回复说“Well, I am the Duke of Normandy!（ …
上海有什么特产比较方便携带？ - 知乎
知乎，中文互联网高质量的问答社区和创作者聚集的原创内容平台，于 2011 年 1 月正式上线，以「让人们更好的分享知识、经验和见解，找到自己的解答」为品牌使命。知乎凭借认真、专业 …
东北大学在985里什么水平？ - 知乎
当然你东去美国不错，听说88能上duke ece（虽然duke cs方面不是很强但是牌子好啊），也有一位上了ucb的牛人。说明牢美还是有几把刷子，狠狠认可。不过老美金币爆的确实有些多了， …
