""This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing."" -Microbiology Today, May 2009

Written in a clear and concise style by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices.

Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices.

The book covers everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

Selected by the Association of University Programs in Health Administration for the Bugbee-Falk Book Award Is the health sector a curse or a blessing? The American health sector now accounts for a fifth of the economy. American healthcare spending per capita far exceeds that of other developed countries. Yet our health, as measured by life expectancy and infant mortality, is poor by comparison with the developed world. Other measures of quality including hospital-acquired infection are too common. Healthcare costs financially cripple households despite advances associated with the Affordable Care Act. There is widespread dissatisfaction with the American healthcare system and support for more change. It is also the case that the health sector has been a leader in the evolution of the American economy. Economic development is driven by innovative technology. We tend to applaud new technology and the improvement it brings to our lives. Important recent technologies often grow rapidly and faster than the wider economy. This leads to larger shares of the economy. Yet there is considerable apprehension about costs and economic impact of health spending. This book details important health sector institutions and uniquely, explores linkages between healthcare and broader economic growth. The book addresses asymmetric information between providers and consumers as well as between insurers and beneficiaries. There is a focus on monopoly power in labor markets which contributes to inefficiencies in the system. The author also discusses cost-effectiveness and allocative efficiency as well as emphasizing productivity and its relationship to the wider economy.

How can a smartwatch help patients with diabetes manage their disease? Why can't patients find out prices for surgeries and other procedures before they happen? How can researchers speed up the decade-long process of drug development? How will "Precision Medicine" impact patient care outside of cancer? What can doctors, hospitals, and health systems do to ensure they are maximizing high-value care? How can healthcare entrepreneurs find success in this data-driven market? A revolution is transforming the $10 trillion healthcare landscape, promising greater transparency, improved efficiency, and new ways of delivering care. This new landscape presents tremendous opportunity for those who are ready to embrace the data-driven reality. Having the right data and knowing how to use it will be the key to success in the healthcare market in the future. We are already starting to see the impacts in drug development, precision medicine, and how patients with rare diseases are diagnosed and treated. Startups are launched every week to fill an unmet need and address the current problems in the healthcare system. Digital devices and artificial intelligence are helping doctors do their jobs faster and with more accuracy. MoneyBall Medicine: Thriving in the New Data-Driven Healthcare Market, which includes interviews with dozens of healthcare leaders, describes the business challenges and opportunities arising for those working in one of the most vibrant sectors of the world's economy. Doctors, hospital administrators, health information technology directors, and entrepreneurs need to adapt to the changes effecting healthcare today in order to succeed in the new, cost-conscious and value-based environment of the future. The authors map out many of the changes taking place, describe how they are impacting everyone from patients to researchers to insurers, and outline some predictions for the healthcare industry in the years to come.

Public Health Practice in Australia offers a thorough introduction to what public health practitioners do, and the 'effort' involved in improving the health of the public.This second edition has been fully revised and updated in line with current policies and practice. It highlights common threads that underlie seemingly disparate activities, ideas and entities that comprise the organised effort of public health practice. The emphasis is on securing and maintaining the conditions in society that enable people to live healthy and fulfilling lives.The authors examine the impact of historical, social, economic, environmental and political factors on the health of individuals, communities and populations. Taking an applied, multidisciplinary approach, they outline the strategies and tools that public health practitioners use to improve health outcomes: identifying infrastructure needs in the workforce, public and private sector organisations, and in regulation; gathering, analysing and using health data; applying interventions in health policy, provision of health services and health promotion.Public Health Practice in Australia draws on current international and Australian research and the interwoven case studies make the theories and concepts come alive. It is a valuable resource for students and professionals across the health sciences including public health, medicine, environmental health, health promotion, health information management and health administration.'The book is impressive in the completeness, clarity and consistency of the material covered, and for the way in which many of the theoretical issues are related to current practice. An extremely useful and valuable reference for both students and practitioners alike.' - Thomas Tenkate, Environmental Health

Provides for the first time a comprehensive, state-of-the-art overview of the different types of healthcare robots and the advances that AI brings them. Provides, in an easy and accessible way, essential basic information about the autonomy levels of surgery robots, which is novel. As such, could be very valuable to a broad community that ranges from legal scholars, ethicists, developers, policymakers, students, or non-specialists curious about the topic.

ESSENTIALS OF HEALTH INFORMATION MANAGEMENT: PRINCIPLES AND PRACTICES, Fifth Edition, gives you a thorough introduction to fundamental Health Information Management concepts you'll need to understand as an allied health professional. Learning objectives are correlated and mapped to current CAHIIM curriculum standards, and each chapter includes key terms, assessments and case studies to help you learn and apply important concepts. Updated and expanded to reflect key industry trends, legal and regulatory developments and advances in technology, the Fifth Edition features new content on information systems, data management and security, ethics and cultural diversity and cultural competence, as well as timely resources related to telehealth and telemedicine. In addition, the product suite includes a variety of print and digital options to help you learn the way that's best for you.

-a short handbook designed for practical use by business owners to ensure they act in a professional, ethical and informed way around cybersecurity -first resource of its kind for coaches and therapists

One box of chemicals mistaken for another. Ingredients intended to be life-sustaining are instead life-taking. Families in shock, healthcare providers reeling and fingers starting to point. A large healthcare system's reputation hangs in the balance while decisions need to be made, quickly. More questions than answers. People have to be held accountable - does this mean they get fired? Should the media and therefore the public be informed? What are family members and the providers involved feeling? When the dust settles, will remaining patients be more safe or less safe? In this provocative true story of tragedy, the authors recount the journey travelled and what was learned by, at the time, Canada's largest fully integrated health region. They weave this story together with the theory about why things fall apart and how to put them back together again. Building on the writings and wisdom of James Reason and other experts, the book explores new ways of thinking about Just Culture, and what this would mean for patients and family members, in addition to healthcare providers. With afterwords by two of the major players in this story, the authors make a compelling case that Just Culture is as much about fairness and healing as it is about supporting a safety culture.

Contemporary globalization has had tremendous impact on health equity across the globe. However, no volume has systematically analyzed the relationship between globalization and global trends in health outcomes. This book consolidates and updates the findings of a global research project undertaken by the Globalisation Knowledge Network (GKN) of the World Health Organization's Commission on Social Determinants of Health. Chapters examine such questions as: How has trade liberalisation affected the social determinants of health? How has globalization affected food security, nutrition and equitable access to water and sanitation? How well do present global governance structures take account of the health equity effects associated with the social determinants of health? This landmark volume will be a necessary addition for researchers and scholars studying the field of globalization, health and social policy, and public health across the social sciences.

The right to health, having been previously neglected is now being deployed more and more often in litigation, activism and policy-making across the world. International bodies such as the WHO, UNAIDS, World Bank and WTO are increasingly using or being evaluated with reference to health rights, and international NGOs frequently use the language of rights in campaigning and in more concrete litigation. This book brings together an impressive array of internationally renowned scholars in the areas of law, philosophy and health policy to critically interrogate the development of rights based approaches to health. The volume integrates discussion of the right to health at a theoretical level in law and ethics, with the difficult substantive issues where the right is relevant, and with emerging systems of global health governance. The contributions to this volume will add to our theoretical and practical understanding of rights based approaches to health.

This volume looks at the relationship between society and human resource management (HRM) in China. In doing so it asks how representative the latter is of the former. The contributors argue that there needs to be a minimum degree of consonance between these two variables if HRM is to be sufficiently underpinned by social reality. It is only in a wider framework that 'people-management' in general - and in China in particular - can be fully understood, whether through theory or through practice. Society and HRM in China explores the changes in Chinese society over the last century and then goes on to analyse how these changes have shaped China's HRM. Arguably, HRM did not emerge from the void; it was shaped by the societal culture from which it sprung and the economic forces influencing its institutions and organizations. However, there is very little academic literature about the relationship between contemporary Chinese society and its HRM which isn't extremely specific. As such, much of the research in this collection is not only relatively representative but also highly cross-sectional. The contributions are all drawn from experts in the field across the disciplines, hailing from a diverse range of national origins and educational institutions. They cover a wide range of topics, approaches and emphases. This book was originally published as a special issue of The International Journal of Human Resource Management.

A paradigm shift in the ways in which mental health services are delivered is happening-both for service users and for professional mental healthcare workers. The landscape is being changed by a more influential service user movement, a range of new community-based mental healthcare programmes delivered by an increasing plurality of providers, and new mental health policy and legislation. Written by a team of experienced authors and drawing on their expertise in policy and clinical leadership, Working in Mental Health: Practice and Policy in a Changing Environment explains how mental health services staff can operate and contribute in this new environment. Divided into three parts, the first focuses on the socio-political environment, incorporating service user perspectives. The second section looks at current themes and ways of working in mental health. It includes chapters on recovery, the IAPT programme, and mental healthcare for specific vulnerable populations. The final part explores new and future challenges, such as changing professional roles and commissioning services. The book focuses throughout on the importance of public health approaches to mental healthcare. This important text will be of interest to all those studying and working in mental healthcare, whether from a nursing, medical, social work or allied health background.

The Commission on Accreditation of Medical Transport Systems (CAMTS) has been accrediting air and ground transport services since 1991. One of the most significant needs the Commission has recognized is to assist transport services in creating a culture that supports safety and quality for both crews and patients. Most of the helicopter EMS (emergency medical service) accidents and many ground ambulance accidents can be attributed to human factors and systems designs that lead to poor decision-making. Management commitment is vital to create and maintain a culture that supports risk assessment, accountability, professionalism and organizational dynamics. This reference book has been created by CAMTS to address this need directly and comprehensively. It offers a groundbreaking collection of expert insights and practical solutions that can be used by EMS, Fire and Rescue, public and private services, and professional emergency and transport professionals worldwide. Quoting from the foreword written by the late Robert L. Helmreich, Professor Emeritus of Psychology at The University of Texas Human Factors Research Project, 'This is an important book which should be required reading for everyone involved in patient transport, from managers and dispatchers to those at the sharp end... The experienced and able authors and editors of this work use culture as the overarching concept needed to maximize safety while delivering patients expeditiously.'

Despite the growing emphasis on a population-based training and service delivery model for school psychology, few resources exist to provide guidance concerning how such services might be conceptualized and put into place. In this book, the authors propose a public health model for comprehensive children's mental health services that expands, rather than replaces, the traditional model of school psychology. The background and theoretical perspective for this public health model are discussed as an important way to solve problems and accomplish goals in schools, after which the authors outline and develop a clear, practical procedure for implementing and evaluating programs based on public health ideas. A case study in one elementary school walks readers through the stages of applying a public health model, detailing the key steps of each stage. Finally, the authors consider the changes to the role of school psychologist that will be required to practice a public health problem-solving model. Accompanying downloadable resources contain sample forms, handouts, and other valuable materials that will be of use to school psychologists implementing this public health model in their schools.

There is no shortage of literature about working with men in counseling and psychotherapy, but almost none of it addresses the unique issues that a female clinician can face with a male client. These women do not have a basis for a complete understanding of the impact our society's ideas about gender can have on a man, his masculinity, and his feelings toward talk therapy, in part because they are not men themselves. The contributors to this book, all female clinicians who have worked extensively with men, have set out to provide their female peers with a guide for therapeutically engaging and helping men. Chapters explore how each author became involved in men's issues, case studies and examples from her own practice that illustrate her approach, and her own assessment of what works best with male clients. Topics considered include core treatment issues, such as transference and counter-transference, beginning and ending therapy with men, and ethical dilemmas; working in different therapy modalities; and doing therapy with diverse populations of men. The book concludes with an edited transcript of a discussion amongst the authors about their personal experiences working with male clients. This will be an important book for all female therapists who work with male clients and are looking for ways to better understand and tailor their approaches to meet the needs of men in therapy.

Until the start of the new century, efforts to strengthen health systems focused solely on the public sector and health programs overseen by public bodies. The private sector was sidelined in certain countries and even banned in others. At the same time, some private-sector stakeholders readily adapted themselves to this special situation so as to avoid becoming part of a structured health system.

This volume notes profound changes in health care around the world in two areas. The stakeholders involved in the health sector are increasing in number and diversifying as a result of the development of the private sector. They are also responding to a process of democratization and decentralization. These developments have been paralleled by greater functional differentiation. Various stakeholders are increasingly specializing in particular areas of the health system: service delivery, procurement, management, financing, and regulation.

The interdependence of health stakeholders becomes more evident along with the increased complexity of delivery systems as these respond to changing demand. There is a compelling need to forge relationships. Such relationships are in fact emerging in developed countries and, more recently, in developing countries. They may be informal, but are increasingly organized and structured.

This Handbook expertly instructs the reader on how to conduct applied health research across a number of disciplines. Particularly aimed at postgraduate health researchers and students of applied health research, it presents and explains a wide range of research designs and other contemporary issues in applied health research. Focusing on learning outcomes, it takes the reader from underpinning epistemological, ontological and methodological considerations through to the key features of highlighted research designs and how to apply these in practice. In so doing, the experienced group of authors guides the reader in the choice of design for their own studies. They both examine the underpinning paradigmatic questions that guide important design choices and also explore the practical considerations that have to be taken into account when conducting research in this field. This book covers a range of designs from different traditions and also points readers to the key literatures in their areas of interest. Master's students across a range of disciplines will find this book invaluable and it will also be an essential reference tool for PhD students and new researchers in applied health research. Contributors include: F. Ahmed, H. Aveyard, S. Baines, A. Bingley, S. Brearley, G. Chatzidamianos, M. Collins, A. Dodd, M. Edwards, N. Fisher, I. Fletcher, T. Gatrell, A. Grinyer, E. Halliday, C. Murray, R.J. Parker, G. Perez Algorta, N. Preston, S. Reilly, J. Simpson, C. Thomas, S. Varey, C. Walshe, D. Wilde

The Internet and the many applications it supports continue to transform and expand the ways in which it is possible to relate, communicate, collaborate, and perform human service work. In this book, human service researchers and practitioners explore major opportunities and challenges to well being, social justice, and human service work that technology use in everyday life has exposed. Drawing on the latest research their contributions examine issues associated with human service practices in the network society, including: the implications of an expanded capacity to share human service data across agency and national boundaries; ethical issues associated with the use of remote sensing and surveillance technologies (e.g. the satellite tracking of offenders, and telecare services for older people); the risks and benefits of social network sites including issues associated with online privacy, intimacy, and safety; and the influence of technology-mediated services on human relationships and the sense of 'being present' with another person. Human Services in the Network Society will be of considerable interest to human service professionals, academics and researchers who are concerned about the social impact of networked technologies. This book was previously published as a special issue of the Journal of Technology in Human Services.

Workers and their families, employers, and society as a whole benefit when providers deliver the best quality of care to injured workers and when they know how to provide effective services for both prevention and fitness for duty and understand why, instead of just following regulations. Designed for professionals who deliver, manage, and hold oversight responsibility for occupational health in an organization or in the community, Occupational Health Services guides the busy practitioner and clinic manager in setting up, running, and improving healthcare services for the prevention, diagnosis, treatment, and occupational management of work-related health issues. The text covers: an overview of occupational health care in the US and Canada: how it is organized, who pays for what, how it is regulated, and how workers' compensation works how occupational health services are managed in practice, whether within a company, as a global network, in a hospital or medical group practice, as a free-standing clinic, or following other models management of core services, including recordkeeping, marketing, service delivery options, staff recruitment and evaluation, and program evaluation depth and detail on specific services, including clinical service delivery for injured workers, periodic health surveillance, impairment assessment, fitness for duty, alcohol and drug testing, employee assistance, mental health, health promotion, emergency management, global health management, and medico-legal services. This highly focused and relevant combined handbook and textbook is aimed at improving the provision of care and health protection for workers and will be of use to both managers and health practitioners from a range of backgrounds, including but not limited to medicine, nursing, health services administration, and physical therapy.

“There is plenty in this book to get your teeth into and help us think about how we work with people in mental health crises and how we might best make a difference.� Alan Simpson, Professor of Mental Health Nursing, Health Service and Population Research, King’s College London, UK “Any one of us could experience a mental health crisis. However, a high-quality interdisciplinary response can be lifesaving and life changing. This book is an important contribution to the literature as it has examples of good practice for all professionals – both on the frontline and in service development.� Dr Adrian James, President, Royal College of Psychiatrists, UK “This publication is a valuable and timely resource given the increasing recognition of the impact of mental health needs in a range of different professional settings.� Victoria Sweetmore, Acting Discipline Lead for Mental Health and Learning Disability Nursing, University of Derby, UK Interprofessional Perspectives of Mental Health Crisis improves the care of those experiencing a mental health-related crisis by providing insight into the roles different UK statutory services have and the need for collaborative mental health care. For those studying and working in the field of mental health crisis, this vital work will bridge your understanding by offering a cross-discipline perspective of the different services, their role in aiding service users and, the ways we can work more collaboratively together to meet the mental health needs of those requiring care. Throughout, the book: • Promotes understanding of the various roles each of the key services play within the crucial first 24-hours of a mental health crisis and the challenges they face • Fosters interprofessional collaboration to create a whole-system approach to crisis care • Helps professionals to understand good practice and the challenges of other services when aiding a person in crisis • Critically evaluates service provision and ways to improve crisis care • Explores recovery and collaboration with service users experiencing a crisis and their significant others The book is timely and essential in its promotion of high-quality interdisciplinary response and emphasis on integration and collaboration between service providers. Kris Deering is Senior Lecturer in Mental Health Nursing and the module lead of Working with a Person Experiencing a Mental Health Crisis at UWE Bristol, UK. Including working as a senior practitioner for a mental health crisis team, Kris has over 15 years of mental health nursing experience. Jo Williams is Senior Lecturer in Mental Health Nursing at UWE Bristol, UK. Her clinical practice experience includes civilian and military nursing, supporting people living with co-existing mental health and substance misuse issues.

Globalization is a form of social change, reshaping the socio-spatial milieu in which humans strive, and in which health and disease are managed and controlled. And yet the effects of globalization are distributed unevenly, with opportunities open for some but not for all. Globalization, Health and the Global South is an important textbook for any student of this fascinating area. Examining the dynamics of globalization through the lens of the Global South, it highlights risks and vulnerabilities that affect different regions and contexts, exacerbating inequalities despite the continuing speed of global processes. The books takes a critical approach to the topic, offering readers a deep understanding of health discourses and discusses a range of key topics, including migrant health, the role of politics and diplomacy and the Coronavirus pandemic. Including further reading and end of chapter discussion questions, this essential textbook will be important reading for students across the health and social sciences.

EPDF and EPUB available Open Access under CC-BY-NC-ND licence. The COVID-19 pandemic has made unpaid care more visible through its absence, while also increasing the need for it. Drawing on a range of research projects covering Canada, Germany, Norway, Sweden, the UK and the US, this book documents a broad spectrum of unpaid work performed by residents, relatives, volunteers and staff in nursing homes. It demonstrates how boundaries between paid and unpaid work are flexible, varying considerably with conditions, time, place and intersectional populations. By examining the complex labour process within nursing homes, this book provides insight and understanding which will be critical in planning for nursing home care post-pandemic.

Due to the countless variables that affect revenue and cost, the hospital reimbursement process is by far the most complex of any industry. Requiring only a basic financial background and a working knowledge of accounting, Hospital Reimbursement: Concepts and Principles supplies a clear understanding of the concepts and principles that drive the revenue cycle within a hospital setting.

The book explains the technical aspects of reimbursement in language that is easy to comprehend. It illustrates the complexities of the hospital revenue cycle and explains the Medicare and Medicaid financial models in detail. The text also addresses the Medicaid reimbursement methodology, the formulation of the Medicare blend rate, the computation of both DSH and IME, as well as other third-party payers. It also:

• Covers the full range of services and procedures for which a hospital can receive reimbursement
• Explains the difference between a for-profit and not-for-profit hospital
• Contains chapters devoted to Statements of Operations (Income Statement) and Statements of Financial Position (Balance Sheet)
• Examines governmental cost reporting including Worksheets A, A-6, A-8, A-8-2, B-1, B Part 1, C Part 1, D-3, D-5, and E Part A

Supplying readers with a foundation in coding principles, the text also includes a model for calculating the financial impact of variations in patient length of stay. It discusses the DRG and APC reimbursement models and details the computation of an outlier payment. In addition, it walks the reader step-by-step through the creation of a mock Medicare cost report for a sample hospital.