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Chalk Talks in Internal Medicine: Scripts for Clinical Teaching
by Jennifer Wright Somnath Mookherjee Lauren A. Beste Jared W. KleinThis book provides teaching scripts for medical educators in internal medicine and coaches them in creating their own teaching scripts. Every year, thousands of attending internists are asked to train the next generation of physicians to master a growing body of knowledge. Formal teaching time has become increasingly limited due to rising clinical workload, medical documentation requirements, duty hour restrictions, and other time pressures. In addition, today’s physicians-in-training expect teaching sessions that deliver focused, evidence-based content that is integrated into clinical workflow. In keeping with both time pressures and trainee expectations, academic internists must be prepared to effectively and efficiently teach important diagnostic and management concepts.A teaching script is a methodical and structured plan that aids in effective teaching. The teaching scripts in this book anticipate learners’ misconceptions, highlight a limited number of teaching points, provide evidence to support the teaching points, use strategies to engage the learners, and provide a cognitive scaffold for teaching the topic that the teacher can refine over time. All divisions of internal medicine (e.g. cardiology, rheumatology, and gastroenterology) are covered and a section on undifferentiated symptom-based presentations (e.g. fatigue, fever, and unintentional weight loss) is included. This book provides well-constructed teaching scripts for commonly encountered clinical scenarios, is authored by experienced academic internists and allows the reader to either implement them directly or modify them for their own use. Each teaching script is designed to be taught in 10-15 minutes, but can be easily adjusted by the reader for longer or shorter talks.Teaching Scripts in Internal Medicine is an ideal tool for internal medicine attending physicians and trainees, as well as physician’s assistants, nurse practitioners, and all others who teach and learn internal medicine.
Challenge Everything: An Extinction Rebellion Youth Guide To Saving The Planet
by Blue Sandford Extinction RebellionWritten by a founder member of Extinction Rebellion Youth London, this is no greenwashing book – it's an important call to action. A manifesto for how young people can help to save the planet by questioning everything about modern life and acting upon their conclusions.
The Challenge of Chance: A Multidisciplinary Approach from Science and the Humanities (The Frontiers Collection)
by Klaas Landsman Ellen Van WoldeThis book presents a multidisciplinary perspective on chance, with contributions from distinguished researchers in the areas of biology, cognitive neuroscience, economics, genetics, general history, law, linguistics, logic, mathematical physics, statistics, theology and philosophy. The individual chapters are bound together by a general introduction followed by an opening chapter that surveys 2500 years of linguistic, philosophical, and scientific reflections on chance, coincidence, fortune, randomness, luck and related concepts. A main conclusion that can be drawn is that, even after all this time, we still cannot be sure whether chance is a truly fundamental and irreducible phenomenon, in that certain events are simply uncaused and could have been otherwise, or whether it is always simply a reflection of our ignorance. Other challenges that emerge from this book include a better understanding of the contextuality and perspectival character of chance (including its scale-dependence), and the curious fact that, throughout history (including contemporary science), chance has been used both as an explanation and as a hallmark of the absence of explanation. As such, this book challenges the reader to think about chance in a new way and to come to grips with this endlessly fascinating phenomenon.
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
by John GeigertBiopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
by John Geigert"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author! In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed.
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
by John GeigertThis book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
by John GeigertEach year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book:Updates real-world CMC deficiency examples with current examples;Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance;Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
The Challenge of Cognitive Therapy: Applications to Nontraditional Populations (Nato Science Series B:)
by T. Michael Vallis Janice L. Howes Philip C. MillerCognitive therapy is fast becoming one of the more popular and well respected forms of psychotherapy. In both research and clinical practice, several advantages of cognitive therapy have been identified. Cognitive therapy is structured enough to provide a therapeutic framework for clinicians, as well as a theoretical framework for clinical researchers, yet flexible enough to address an individual's problems in a highly idio syncratic manner. Accompanying the popularity of cognitive therapy is the expansion of its application beyond the areas in which it was initially developed and validated (the "traditional" areas of depression and anx iety) to areas where validation has not yet occurred (the "nontraditional" areas). We strongly believe that such broadening of cognitive therapy should be encouraged, but that conceptual models to guide the therapist and researcher in these areas should be explicated. It is the purpose of this text to provide a conceptual framework for dealing with select, nontraditional populations. The idea and motivation for this text develops from a cognitive therapy interest group in Toronto. All of the authors contributing to this text are involved in this group. We represent a group of cognitive thera pists functioning in a variety of diverse settings, including clinical re search units, general hospital settings, private or public rehabilitation centers, and private practices. Thus, the diversity of referrals for cogni tive therapy within our group is great.
The Challenge of Family Therapy: A Dialogue for Child Psychiatric Educators (The Downstate series of research in psychiatry and psychology #3)
by Kalman FlomenhaftThis volume on Family Therapy Training, edited by Kalman Flomenhaft, Ph. D. and Adolph E. Christ, M. D. , is the outgrowth of a successful conference on Family Therapy in the Training of Child Psychiatrists sponsored by the Department of Psychiatry at the Downstate Medical Center on December 8 and 9, 1978. The attendance and enthusiastic participation at this conference reflected the growing interest on the part of psychiatrists and other mental health professionals in the theory, practice, and teaching of family therapy. That the conference was held at all presupposed the value that psychiatric educators are attaching to the incorporation of family therapy teaching in the educational development of psychiatrists. While the conference was dedicated to family therapy training for child psychiatrists, this volume is broadened to include family therapy training for all psychiatrists and mental health profes sionals. The various chapters delineate the issues in the teaching of family therapy, both theoretical and practical. The richness of the chapters that follow grows out of the depth of practical experience of the various authors in developing family therapy training in established programs where resistance to new ideas as well as structural changes in curriculum are predictable. The nature of both the theoretical and practical aspects of such resistances is well described. The authors also emphasize what is required to launch a successful training program in child psychiatry, stressing the importance of attractive role models as teachers of family therapy.
The Challenge of Health Sector Reform: What Must Governments Do? (Role of Government in Adjusting Economies)
by A. Mills S. Bennett S. RussellNew thinking about the management of public health services has stimulated a widespread movement for health sector reform across the world. This book examines the feasibility and desirability of common reforms in low income countries, based on in-depth case studies in Ghana, Zimbabwe, Sri Lanka, India and Thailand, and asks whether governments possess or can develop the capacities needed for these new and often complex roles. The book challenges conventional reform wisdom, and argues that reform approaches are needed that are more sensitive to the institutional characteristics of individual countries.
The Challenge of Highly Pathogenic Microorganisms: Mechanisms of Virulence and Novel Medical Countermeasures
by Avigdor Shafferman Arie Ordentlich Baruch VelanThe OHOLO conferences are sponsored by the Israel Institute for Biological Research and take their name from the site of the ?rst meeting on the shores of Lake Kinnereth. The purpose of these meetings is, as it was at their inception over 50 years ago, “to foster interdisciplinary communication between scientists in Israel, and to provide added stimulus by the participation of invited scientists from abroad”. The core of the organizers of the OHOLO conferences are scientists from the Israel Institute for Biological Research. From time to time a particular OHOLO conference cooperates with an international scienti?c organization. The present 46th OHOLO Conference marks the resumption of the OHOLO tradition after 8 years of interruption caused by events beyond our control. It is my belief that our uncomp- mising commitment to excellence in research and development in the various areas of science in Israel is essential to our survival in this troubled region. The OHOLO conference tradition is a re?ection of this conviction. The present 46th OHOLO Conference entitled: The Challenge of Highly Pathogenic Microorganisms – Mechanisms of Virulence and Novel Medical Countermeasures intends to address the unique virulence features and ho- pathogen interactions of microorganisms constituting emerging biothreat with emphasis on Y. pestis, B. anthracis, F. tularensis and Orthopox viruses. Accordingly we selected classical microbiological as well as genomic, proteomic & transcr- tomic approaches towards developments of novel prophylactic and post-exposure treatment, as well as updated strategies of diagnostics and bioforensics.
The Challenge of Person-centred Care: An Interprofessional Perspective
by Georgina Koubel Hilary BungayThis impressive book brings together two major tenets of modern healthcare: person-centred care and interprofessional working, in order to utilise different perspectives on practice to identify the best treatment for the individual. In a three-part structure covering theory, ethics and practice, The Challenge of Person-Centred Care provides: jargon-free explanations of the role of person-centred care for each professional group clear advice to prepare students for practice numerous case studies and scenarios to illustrate how theory can be applied As a text that engages readers in ethical and moral debates, The Challenge of Person-Centred Care is an essential resource for health and social care students and practitioners. By inspiring critical thinking and reflection on the varied practice roles, it contributes towards improving patient experience in the future.
The Challenge of Person-centred Care: An Interprofessional Perspective
by Georgina Koubel Hilary BungayThis impressive book brings together two major tenets of modern healthcare: person-centred care and interprofessional working, in order to utilise different perspectives on practice to identify the best treatment for the individual.In a three-part structure covering theory, ethics and practice, The Challenge of Person-Centred Care provides:- Jargon-free explanations of the role of person-centred care for each professional group- Clear advice to prepare students for practice- Numerous case studies and scenarios to illustrate how theory can be applied- As a text that engages readers in ethical and moral debates, The Challenge of Person-Centred Care is an essential resource for health and social care students and practitioners. By inspiring critical thinking and reflection on the varied practice roles, it contributes towards improving patient experience in the future.
The Challenge of Promoting Health: Exploration and Action
by Moyra SidellThis book sets the promotion of health on wider agendas. Starting at the local level and the interface between primary health care and the community, it explores potentials for participation and the building of health alliances. It then takes a searching look at how health policy is made and the scope for intersectoral working. The role of poverty and unemployment in determining health chances is explored. A range of ethical, professional, sociological, epidemiological and gender-related issues are addressed.
The Challenge of Regulating Managed Care (The University of Michigan Forum on Health Policy)
by John Eugene Billi Gail Bopp AgrawalRepresentatives of industry, government, caregivers, and consumers join scholars and policy analysts in comparing market forces to regulation as potential means for righting what is wrong with managed care. The contributors that John E. Billi and Gail B. Agrawal have gathered here quickly move the healthcare debate beyond the classroom, think tank, and statehouse to the boardroom and examining room. Some argue strongly that the solution is to be found in the democratic process and government intervention, while others maintain that only market forces in a competitive environment can respond quickly to the needs of consumers and purchasers alike. The contributors' diverse opinions about the oversight of managed care reflect an enduring divide, one that will affect how society ultimately resolves questions about the inevitable tradeoffs among health-care quality, cost, and access in an environment of limited resources. The Challenge of Regulating Managed Care will appeal to policymakers, those in the medical field, and all readers interested in the American experience with managed care. John E. Billi is Associate Professor of Internal Medicine and Medical Education; Associate Dean for Clinical Affairs, University of Michigan Medical School; and Associate Vice President for Medical Affairs, University of Michigan. Gail B. Agrawal is Associate Professor of Law, University of North Carolina, Chapel Hill.
The Challenge of Sexuality in Health Care
by Hazel Heath Isabel WhiteThis book provides a comprehensive overview of the range of issues and concerns related to sexuality and health care. It describes the normal processes and issues which arise at different stages in a person's life connected with sexuality, and goes on to describe the particular issues and concerns that arise when there is illness, disfigurement, physical or mental disability. The Challenge of Sexuality in Health Care will provide qualified nurses, students, and health care professionals with the confidence to encourage patients to raise any concerns they might have.
The Challenge to Change: Reforming Health Care on the Front Line in the United States and the United Kingdom (The Culture and Politics of Health Care Work)
by Rebecca Kolins GivanThere is constant pressure on hospitals to improve health care delivery and increase cost effectiveness. New initiatives are the order of the day in the dramatically different health care systems of the United States and Great Britain. Often, as we know all too well, these efforts are not successful. In The Challenge to Change, Rebecca Kolins Givan analyzes the successes and failures of efforts to improve hospitals and explains what factors make it likely that the implementation of reforms will rewarded by positive transformation in a particular institution’s day-to-day operation. Givan’s in-depth qualitative case studies of both top-down initiatives and changes first suggested by staff on the front lines of care point clearly to the importance of all hospital workers in effecting change and even influencing national policy.Givan illuminates the critical role of workers, managers, and unions in enabling or constraining changes in policies and procedures and ensuring their implementation. Givan spotlights an Anglo-American model of hospital care and work organization, even while these countries retain their differences in access and payment. Entrenched professional roles, hierarchical workplace organization, and the sometimes-detached view of policymakers all shape the prospects for change in hospitals. Givan provides important examples of how the dedication and imagination of the people who work in hospitals can make all the difference when it comes to providing quality health care even in a challenging economic environment.
Challenges and Choices for Patient, Carer and Professional at the End of Life: Living with Uncertainty
by Catherine Proot Michael YorkeLiving with Uncertainty gives a broad perspective on the complexities and challenges of the practice of end-of-life care, as well as the perceived benefits and limitations of medical intervention. Drawn from research and clinical and pastoral experience, the book examines the feelings associated with the end of life, highlighting the demands that people are faced with and their consequences. It moves into the difficult area of people who feel defeated by their illness and can or want to live no longer, as well as the family, caregivers and professionals who surround them. These perspectives have been built upon around a hundred narratives of lived experience, combined with the wider clinical and practical range of voices. A topical post-script Lessons from Covid-19 captures the choices and challenges on a personal, professional and systemic level which the pandemic acutely revealed with a multiplicity of examples. This will be essential reading for students and professionals in palliative and end-of-life care. Families and friends will also benefit from this book as they try to come to terms with the delicate but universal issues of death and dying.
Challenges and Choices for Patient, Carer and Professional at the End of Life: Living with Uncertainty
by Catherine Proot Michael YorkeLiving with Uncertainty gives a broad perspective on the complexities and challenges of the practice of end-of-life care, as well as the perceived benefits and limitations of medical intervention. Drawn from research and clinical and pastoral experience, the book examines the feelings associated with the end of life, highlighting the demands that people are faced with and their consequences. It moves into the difficult area of people who feel defeated by their illness and can or want to live no longer, as well as the family, caregivers and professionals who surround them. These perspectives have been built upon around a hundred narratives of lived experience, combined with the wider clinical and practical range of voices. A topical post-script Lessons from Covid-19 captures the choices and challenges on a personal, professional and systemic level which the pandemic acutely revealed with a multiplicity of examples. This will be essential reading for students and professionals in palliative and end-of-life care. Families and friends will also benefit from this book as they try to come to terms with the delicate but universal issues of death and dying.
Challenges and Opportunities for Respiratory Syncytial Virus Vaccines (Current Topics in Microbiology and Immunology #372)
by Larry J. Anderson and Barney S. GrahamAlthough respiratory syncytial virus (RSV) has been a high priority for vaccine development for over 50 years now, still no vaccine is available and none has yet demonstrated sufficient promise to move to licensure. The success of RSV immune prophylaxis and the availability of ever more powerful tools to study the immune response and pathogenesis of disease, combined with the ability to construct a wide variety of vaccines using different vaccine platforms, give us grounds to believe that an RSV vaccine is within reach. This book brings together in one source what is currently known about the virus: its clinical and epidemiologic features; the host response and pathogenesis of the disease; vaccines, vaccine platforms, and treatment; and animal and tissue culture models of RSV infection. It is designed to organize the critical information relevant to RSV vaccine development, facilitate the assimilation of data, and speed progress toward producing a safe and effective vaccine.
Challenges and Opportunities in Health Care Management
by Sebastian Gurtner Katja SoyezThis contributed volume draws a vital picture of the health care sector, which, like no other is affected by technology push and stakeholder pull. Innovative product and service solutions emerge, which have to integrate different stakeholders’ interests. This book studies current challenges in health care management from different perspectives. Research articles analyze the situation in the health care sector and present solutions in the following areas: the health care system; hospitals; teams in health care; patients’ perspectives; assessment of technologies and innovations; and toolkits for organizing health care. All these contributions summarize pressing hot topics in the health care sector, analyze their future potential, and derive managerial implications. Outstanding best practices throughout Europe are presented in the case study section of the book. Consequently, the book closes the gap between science and practical application by addressing not only readers from academia but also practitioners working in the health care industry.
Challenges and Opportunities in Health Professions Education: Perspectives in the Context of Cultural Diversity
by Mora Claramita Ardi Findyartini Dujeepa D. Samarasekera Hiroshi NishigoriThis book addresses health professions educational challenges specific to non-Western cultures, implementing a shifting paradigm for educating future health professionals towards patient-centered care. While health professions education has received increasing attention in the last three decades, promoting student-centered learning principles pioneered by leaders in the medical community has, for the most part, remain rooted in the Western context. Building from Hofstede’s analysis of the phenomena of cultural dimensions, which underpin the way people build and maintain their relationships with others and influence social, economic, and political well-being across nations, this book demarcates the different cultural dimensions between East and West, applied to medical education. The respective ‘hierarchical’ and ‘collectivist’ cultural dimensions are unpacked in several studies stemming from non-western countries, with the capacity to positively influence healthcare education and services. The book provides new insights for researchers and health professional educators to understand how cultural context influences the input, processes, and output of health professionals’ education. Examples include how cultural context influences the ways in which students respond to teachers, how teachers giving feedback to students, and the challenges of peer feedback and group work. The authors also examine causes for student hesitation in proposing ideas, the pervasive cultural norm of maintaining harmony, the challenges of teamwork in clinical settings, the need to be sensitive to community health needs, the complexity of clinical decision making, and the challenge of how collectivist cultural values play into group dynamics. This book aims to advocate a more culturally-sensitive approach to educating health professionals, and will be relevant to both students and practitioners in numerous areas of public health and medical education.
Challenges and Opportunities in Public Service Interpreting
by Théophile Munyangeyo Graham Webb Marina Rabadán-GómezPublic Service Interpreting is a hugely complex activity, encompassing human, ethical, commercial and political dimensions. It is unseen and unrecognized by most of the population but vital to those who depend on it for their security or wellbeing. The quality of PSI provision is seen by the authors as a clear indicator of how a society views and responds to the realities of a multi-ethnic and multilingual global community. Following recent significant changes in the power balance between them this book explores the increasing tensions among multiple stakeholders who together deliver such a fundamental service in a modern open society. Chapters focus on how all stakeholders need to appreciate the wider context of political and economic realities whilst collaborating more responsibly to deliver the conditions, training and support needed for expert linguists to be attracted to and retained in this vital profession.
Challenges and Opportunities of mRNA Vaccines Against SARS-CoV-2: A Multidisciplinary Perspective
by Siguna MuellerThis book offers an analytical look at the much debated risks and benefits of the newly developed COVID-19 mRNA-vaccines. As such, it is one of the first books to give a comprehensive overview of mRNA vaccines against COVID-19 and the only one that addresses this topic from a broad multidisciplinary background. It brings together insights from various underlying disciplines on the challenges of developing and evaluating the most suitable vaccines for mass vaccination programs enrolled throughout the world - focusing on safety and efficacy.This book should not be missing on the shelf of any biomedical researcher, epidemiologist, public health professional or clinical researcher interested in SARS-CoV2 or virology and vaccine development in general.
Challenges and Solutions: Narratives of Patient-Centered Care
by Judith Belle Brown Tanya Thornton Moira StewartThe foundation of patient-centered care is the patient-professional relationship. By exploring both the disease and patients' unique experience of illness, healthcare professionals take into consideration their individual needs as well as their emotional and physical concerns. Using narratives to describe experiences of patients and professionals, this book reveals the four interactive components of the patient-centered clinical method: exploring health, disease and illness; understanding the whole person; finding common ground; and enhancing the patient-doctor relationship. The concluding chapters illustrate ways in which all four components interact with and complement each other and can be used in unison to the immeasurable benefit of both patient and professional. The stimulating narratives are all based on recent developments in the theoretical model of patient-centred clinical care. This wide-ranging, thought-provoking text is highly relevant to a wide range of healthcare professionals as well as medical educators and healthcare students. For physicians, narratives provide insight and illumination of what it truly means to be patient-centered. They also help clinicians to examine, in a reflective manner, what it means to be a healer. From the Introduction