Read Books Online and Download eBooks, EPub, PDF, Mobi, Kindle, Text Full Free.
Download Comprehensive Market And Regulatory Strategies For Medical Care full books in PDF, epub, and Kindle. Read online Comprehensive Market And Regulatory Strategies For Medical Care ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
Author : Walter J. McClure
Publisher :
ISBN 13 :
Total Pages : 538 pages
Book Rating : 4.3/5 (91 download)
Download or read book Comprehensive Market and Regulatory Strategies for Medical Care written by Walter J. McClure and published by . This book was released on 1979 with total page 538 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309047420
Total Pages : 240 pages
Book Rating : 4.3/5 (9 download)
Download or read book Access to Health Care in America written by Institute of Medicine and published by National Academies Press. This book was released on 1993-02-01 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans are accustomed to anecdotal evidence of the health care crisis. Yet, personal or local stories do not provide a comprehensive nationwide picture of our access to health care. Now, this book offers the long-awaited health equivalent of national economic indicators. This useful volume defines a set of national objectives and identifies indicatorsâ€"measures of utilization and outcomeâ€"that can "sense" when and where problems occur in accessing specific health care services. Using the indicators, the committee presents significant conclusions about the situation today, examining the relationships between access to care and factors such as income, race, ethnic origin, and location. The committee offers recommendations to federal, state, and local agencies for improving data collection and monitoring. This highly readable and well-organized volume will be essential for policymakers, public health officials, insurance companies, hospitals, physicians and nurses, and interested individuals.
Author : Susan Onel
Publisher :
ISBN 13 : 9781402427749
Total Pages : 1112 pages
Book Rating : 4.4/5 (277 download)
Download or read book Medical Devices Law and Regulation Answer Book written by Susan Onel and published by . This book was released on 2016-11 with total page 1112 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.
Author : Elijah Wreh
Publisher : Elsevier
ISBN 13 : 0323953530
Total Pages : 680 pages
Book Rating : 4.3/5 (239 download)
Download or read book Medical Device Regulation written by Elijah Wreh and published by Elsevier. This book was released on 2023-02-22 with total page 680 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices. Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification Puts regulations in the context of contemporary design Includes case studies and applications of regulations
Author : David Edward Marcinko
Publisher : CRC Press
ISBN 13 : 1439879907
Total Pages : 417 pages
Book Rating : 4.4/5 (398 download)
Download or read book Hospitals & Health Care Organizations written by David Edward Marcinko and published by CRC Press. This book was released on 2012-07-06 with total page 417 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drawing on the expertise of decision-making professionals, leaders, and managers in health care organizations, Hospitals & Health Care Organizations: Management Strategies, Operational Techniques, Tools, Templates, and Case Studies addresses decreasing revenues, increasing costs, and growing consumer expectations in today’s increasingly competitive health care market. Offering practical experience and applied operating vision, the authors integrate Lean managerial applications, and regulatory perspectives with real-world case studies, models, reports, charts, tables, diagrams, and sample contracts. The result is an integration of post PP-ACA market competition insight with Lean management and operational strategies vital to all health care administrators, comptrollers, and physician executives. The text is divided into three sections: Managerial Fundamentals Policy and Procedures Strategies and Execution Using an engaging style, the book is filled with authoritative guidance, practical health care–centered discussions, templates, checklists, and clinical examples to provide you with the tools to build a clinically efficient system. Its wide-ranging coverage includes hard-to-find topics such as hospital inventory management, capital formation, and revenue cycle enhancement. Health care leadership, governance, and compliance practices like OSHA, HIPAA, Sarbanes–Oxley, and emerging ACO model policies are included. Health 2.0 information technologies, EMRs, CPOEs, and social media collaboration are also covered, as are 5S, Six Sigma, and other logistical enhancing flow-through principles. The result is a must-have, "how-to" book for all industry participants.
Author : Joan Kathryn Twiton
Publisher :
ISBN 13 :
Total Pages : 256 pages
Book Rating : 4.:/5 (241 download)
Download or read book Competition Vs. Regulation in the Health Care Market written by Joan Kathryn Twiton and published by . This book was released on 1991 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : John J. Tobin
Publisher : John Wiley & Sons
ISBN 13 : 3527688986
Total Pages : 341 pages
Book Rating : 4.5/5 (276 download)
Download or read book Medical Product Regulatory Affairs written by John J. Tobin and published by John Wiley & Sons. This book was released on 2023-08-29 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of 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 dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/ Manufacturing Practices. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.
Author : I. Glenn Cohen
Publisher : Cambridge University Press
ISBN 13 : 1108838634
Total Pages : 295 pages
Book Rating : 4.1/5 (88 download)
Download or read book Innovation and Protection written by I. Glenn Cohen and published by Cambridge University Press. This book was released on 2022-04-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Author : Albert I Wertheimer
Publisher : CRC Press
ISBN 13 : 9780789015853
Total Pages : 232 pages
Book Rating : 4.0/5 (158 download)
Download or read book Strategies in Pharmacoeconomics and Outcomes Research written by Albert I Wertheimer and published by CRC Press. This book was released on 2002-10-09 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Get a healthy perspective on pharmaceutical economics! Strategies in Pharmacoeconomics and Outcomes Research presents a comprehensive introduction to the economic aspects of the health sector, focusing on strategies for the development and marketing of healthcare products. A much-needed addition to this relatively new field, the book narrows health economics into the sub-discipline of pharmacoeconomics, bridging the gap between different interest groups in the pharmaceutical industry-research and development at one end, sales and marketing at the other. Using basic terminology and practical examples with descriptive tables and figures, it analyzes the implications of projecting costs of pharmaceutical products as a method of determining the viability of their development. Written from an international perspective, Strategies in Pharmacoeconomics and Outcomes Research examines the costs of drug therapy on health care systems and society through global marketing and modeling strategies, including clinical research and trial examples. Through the interlinked concepts of clinical research, outcomes research and pharmacoeconomics, the book evaluates the effectiveness of health technologies under “real world” circumstances or “normal” medical practice to achieve the optimum benefit from the resources available. The research process follows the economics of a drug?s efficacy (how it works under ideal circumstances) to its effectiveness (how it does in “real” life) to its efficiency (how cost-effective it is) in determining the baseline effects of a disease on economic and humanistic parameters. Strategies in Pharmacoeconomics and Outcomes Research also examines: resources and cost benefits (direct, indirect, intangible, and quality of life) health economical models (decision-tree analysis, Markov-model) reimbursement differences between countries due to the rate of currency exchange drug monitoring and regulation . . . and includes an extensive glossary! At a time when health economics has become increasingly important, Strategies in Pharmacoeconomics and Outcomes Research is an essential tool for the pharmaceutical, diagnostic, and medical device industries to ensure the most efficient use of limited resources. The book?s practical tone and common-sense methods provide a realistic approach that will benefit pharmaceutical and medical professionals, product managers, business development managers, drug regulatory affairs officials, and clinical study coordinators in making strategic and operational decisions about pharmaceutical development, production, or consumption.
Author : OECD
Publisher : OECD Publishing
ISBN 13 : 9264805907
Total Pages : 447 pages
Book Rating : 4.2/5 (648 download)
Download or read book Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309162904
Total Pages : 141 pages
Book Rating : 4.3/5 (91 download)
Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Author : Michael Cheng
Publisher : World Health Organization
ISBN 13 : 9241546182
Total Pages : 54 pages
Book Rating : 4.2/5 (415 download)
Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 1000440516
Total Pages : 806 pages
Book Rating : 4.0/5 (4 download)
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.
Author : Helena Legido-Quigley
Publisher : World Health Organization
ISBN 13 : 9289071931
Total Pages : 242 pages
Book Rating : 4.2/5 (89 download)
Download or read book Assuring the Quality of Health Care in the European Union written by Helena Legido-Quigley and published by World Health Organization. This book was released on 2008 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.
Author : Stuart Altman
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (137 download)
Download or read book Halfway Competitive Markets and Ineffective Regulation written by Stuart Altman and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the late 1960s the U.S. has attempted to develop a strategy for controlling the rate of growth of health care spending. During the 1970s this strategy relied heavily on various forms of regulation. Some regulatory programs were partially successful in moderating spending increases, but they generated significant opposition--particularly from powerful provider groups, who successfully convinced Congress and the states to dismantle most of the regulatory structure and to substitute various forms of competitive approaches to controlling spending. Some of these competitive strategies have been successful in increasing the efficiency of subsections of our health system. But they too have produced losers, and the government has been pressured to enter the system to minimize their losses. The net result has been a political stalemate between halfway competitive markets and ineffective regulation. With the rate of health care spending growth near historic levels, it is likely that the 1990s will bring a return to a stronger role for government regulation. But it is unlikely that we are any more willing to tolerate the negative fallout from regulation today than we were in the 1970s, and therefore we predict that the proportion of GNP going to health care will continue to grow throughout the remainder of this century.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)
Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Author : Gerald B. Halt (Jr.)
Publisher :
ISBN 13 : 9783030044633
Total Pages : 333 pages
Book Rating : 4.0/5 (446 download)
Download or read book FDA and Intellectual Property Strategies for Medical Device Technologies written by Gerald B. Halt (Jr.) and published by . This book was released on 2019 with total page 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators. Investigates the FDA approval process as it pertains to medical device technology Address some of the major FDA hurdles that medical device innovators often face while seeking approval Discusses the interplay between FDA regulatory review of medical device technology and intellectual property strategy Explores the benefits of protecting, managing and enforcing intellectual property obtained for medical device technology so that innovators can obtain the best possible commercial results from their IP ownership Uses real case studies to illustrate concepts covered.
