Download or read book Medical Affairs in the Healthcare Industry written by Dr Peter Kruse and published by Createspace Independent Publishing Platform. This book was released on 2015-12-03 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt: Peter Kruse MD, PhD, has divided a nearly 30 year professional career as a physician, scientist and working for the healthcare industry for global drug, biologics and medical device companies. This introduction to Medical Affairs gives a quick overview of this unique role that provides "the bridge" between Science and Business. Dr. Kruse shares his experience and some tricks of the trade - easy and to the point - for anyone working already in the Medical Affairs field or wishes to join it.
Download or read book Health Professions Education written by Institute of Medicine and published by National Academies Press. This book was released on 2003-07-01 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine study Crossing the Quality Chasm (2001) recommended that an interdisciplinary summit be held to further reform of health professions education in order to enhance quality and patient safety. Health Professions Education: A Bridge to Quality is the follow up to that summit, held in June 2002, where 150 participants across disciplines and occupations developed ideas about how to integrate a core set of competencies into health professions education. These core competencies include patient-centered care, interdisciplinary teams, evidence-based practice, quality improvement, and informatics. This book recommends a mix of approaches to health education improvement, including those related to oversight processes, the training environment, research, public reporting, and leadership. Educators, administrators, and health professionals can use this book to help achieve an approach to education that better prepares clinicians to meet both the needs of patients and the requirements of a changing health care system.
Download or read book Medical Regulatory Affairs written by Jack Wong and published by CRC Press. This book was released on 2022-01-27 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Download or read book For Profit Enterprise in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 1986-01-01 with total page 580 pages. Available in PDF, EPUB and Kindle. Book excerpt: "[This book is] the most authoritative assessment of the advantages and disadvantages of recent trends toward the commercialization of health care," says Robert Pear of The New York Times. This major study by the Institute of Medicine examines virtually all aspects of for-profit health care in the United States, including the quality and availability of health care, the cost of medical care, access to financial capital, implications for education and research, and the fiduciary role of the physician. In addition to the report, the book contains 15 papers by experts in the field of for-profit health care covering a broad range of topicsâ€"from trends in the growth of major investor-owned hospital companies to the ethical issues in for-profit health care. "The report makes a lasting contribution to the health policy literature." â€"Journal of Health Politics, Policy and Law.
Download or read book Conflict of Interest in Medical Research Education and Practice written by Institute of Medicine and published by National Academies Press. This book was released on 2009-09-16 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.
Download or read book Evidence Based Medicine and the Changing Nature of Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2008-09-06 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.
Download or read book The Medical Affairs Toolbox written by Peter Kruse, M.D. and published by Createspace Independent Publishing Platform. This book was released on 2017-03-18 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Affairs is of growing importance to the Healthcare Industry. To be able to provide optimal support to your Medical Affairs role you will need to "master" different tools. Your goal is to strive for excellence in Medical Affairs. This book gives an overview of one of the fundamental and important tools in The Medical Affairs Toolbox: Publication Planning. The art of ensuring that scientific and clinical data are generated in the development of a healthcare product to the right time and audience while adhering to best standards and guidelines. The author shares his experience and some tricks of the trade on effective Publication Planning both for larger and smaller companies. This book has its own living facebook page: https: //www.facebook.com/Publicationplanning/This is book 3 of the series "Healthcare Industry Excellence". Other books in this series are: Want a career in the Healthcare Industry? https: //www.amazon.com/gp/product/1530160421/ref=dbs_a_def_rwt_bibl_vppi_i2Medical Affairs an introductionhttps: //www.amazon.com/gp/product/151962901X/ref=dbs_a_def_rwt_bibl_vppi_i0
Download or read book Health Care Comes Home written by National Research Council and published by National Academies Press. This book was released on 2011-06-22 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the United States, health care devices, technologies, and practices are rapidly moving into the home. The factors driving this migration include the costs of health care, the growing numbers of older adults, the increasing prevalence of chronic conditions and diseases and improved survival rates for people with those conditions and diseases, and a wide range of technological innovations. The health care that results varies considerably in its safety, effectiveness, and efficiency, as well as in its quality and cost. Health Care Comes Home reviews the state of current knowledge and practice about many aspects of health care in residential settings and explores the short- and long-term effects of emerging trends and technologies. By evaluating existing systems, the book identifies design problems and imbalances between technological system demands and the capabilities of users. Health Care Comes Home recommends critical steps to improve health care in the home. The book's recommendations cover the regulation of health care technologies, proper training and preparation for people who provide in-home care, and how existing housing can be modified and new accessible housing can be better designed for residential health care. The book also identifies knowledge gaps in the field and how these can be addressed through research and development initiatives. Health Care Comes Home lays the foundation for the integration of human health factors with the design and implementation of home health care devices, technologies, and practices. The book describes ways in which the Agency for Healthcare Research and Quality (AHRQ), the U.S. Food and Drug Administration (FDA), and federal housing agencies can collaborate to improve the quality of health care at home. It is also a valuable resource for residential health care providers and caregivers.
Download or read book Engineering a Learning Healthcare System written by National Academy of Engineering and published by National Academies Press. This book was released on 2011-06-14 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving our nation's healthcare system is a challenge which, because of its scale and complexity, requires a creative approach and input from many different fields of expertise. Lessons from engineering have the potential to improve both the efficiency and quality of healthcare delivery. The fundamental notion of a high-performing healthcare system-one that increasingly is more effective, more efficient, safer, and higher quality-is rooted in continuous improvement principles that medicine shares with engineering. As part of its Learning Health System series of workshops, the Institute of Medicine's Roundtable on Value and Science-Driven Health Care and the National Academy of Engineering, hosted a workshop on lessons from systems and operations engineering that could be applied to health care. Building on previous work done in this area the workshop convened leading engineering practitioners, health professionals, and scholars to explore how the field might learn from and apply systems engineering principles in the design of a learning healthcare system. Engineering a Learning Healthcare System: A Look at the Future: Workshop Summary focuses on current major healthcare system challenges and what the field of engineering has to offer in the redesign of the system toward a learning healthcare system.
Download or read book Inventing the Future written by Dennis Gabor and published by . This book was released on 1963 with total page 199 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Download or read book Global Pharmaceuticals written by Adriana Petryna and published by Duke University Press. This book was released on 2006-03-15 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: DIVAnthropological study of the globalization of pharmaceuticals and its effects on local cultures, health, and economics./div
Download or read book Enhancing Data Systems to Improve the Quality of Cancer Care written by National Research Council and published by National Academies Press. This book was released on 2000-10-09 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the barriers to improving the quality of cancer care in the United States is the inadequacy of data systems. Out-of-date or incomplete information about the performance of doctors, hospitals, health plans, and public agencies makes it hard to gauge the quality of care. Augmenting today's data systems could start to fill the gap. This report examines the strengths and weaknesses of current systems and makes recommendations for enhancing data systems to improve the quality of cancer care. The board's recommendations fall into three key areas: Enhance key elements of the data system infrastructure (i.e., quality-of-care measures, cancer registries and databases, data collection technologies, and analytic capacity). Expand support for analyses of quality of cancer care using existing data systems. Monitor the effectiveness of data systems to promote quality improvement within health systems.
Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Download or read book The New Health Care for Profit written by Institute of Medicine and published by National Academies Press. This book was released on 1983-01-01 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: An introduction to the new health care for profit. Legal differences between investor-owned and nonprofit health care institutions. Wall Street and the for-profit hospital management companies. When investor-owned corporations buy hospitals: some issues and concerns. Physician involvement in hospital decision making. Economic incentives and clinical decisions. Ethical dilemmas of for-profit enterprise in health care. Secondary income from recommended treatment: should fiduciary principles constrain physician behavior?
Download or read book Code Blue written by Mike Magee and published by Atlantic Monthly Press. This book was released on 2019-06-04 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: This “searing and persuasive exposé of the American health care system” demonstrates the disastrous consequences of putting profit before people (Kirkus Reviews, starred review). In this timely and important book, Mike Magee, M.D., sends out a “Code Blue” —an urgent medical emergency—for the American medical industry itself. A former hospital administrator and Pfizer executive, he has spent years investigating the pillars of our health system: Big Pharma, insurance companies, hospitals, the American Medical Association, and anyone affiliated with them. Code Blue is a riveting, character-driven narrative that draws back the curtain on the giant industry that consumes one out of every five American dollars. Making clear for the first time the mechanisms, greed, and collusion by which our medical system was built over the last eight decades. He persuasively argues for a single-payer, multi-plan insurance arena of the kind enjoyed by every other major developed nation.
Download or read book The Role of Human Factors in Home Health Care written by National Research Council and published by National Academies Press. This book was released on 2010-11-14 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.
