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A Proposal For A New Regulatory Framework For In Vitro Diagnostic Devices
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Author :National Coordinating Committee for Therapeutic Goods In Vitro Diagnostic Device Working Group (Australia) Publisher : ISBN 13 :9781920746056 Total Pages :74 pages Book Rating :4.7/5 (46 download)
Book Synopsis A Proposal for a New Regulatory Framework for in Vitro Diagnostic Devices by : National Coordinating Committee for Therapeutic Goods In Vitro Diagnostic Device Working Group (Australia)
Download or read book A Proposal for a New Regulatory Framework for in Vitro Diagnostic Devices written by National Coordinating Committee for Therapeutic Goods In Vitro Diagnostic Device Working Group (Australia) and published by . This book was released on 2003 with total page 74 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Book Synopsis First WHO Model List of Essential In Vitro Diagnostics by : World Health Organization
Download or read book First WHO Model List of Essential In Vitro Diagnostics written by World Health Organization and published by World Health Organization. This book was released on 2019-05-16 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt: The objective of the list is to help countries develop or update their national essential diagnostics lists, raise awareness and political will, guide procurement and regulation policies and improve access to the most important in vitro diagnostics that all countries need to make available to their populations, particularly in low-resourced countries. It will also contribute towards health systems strengthening and realizing universal health coverage.
Book Synopsis Biocompatibility and Performance of Medical Devices by : Jean-Pierre Boutrand
Download or read book Biocompatibility and Performance of Medical Devices written by Jean-Pierre Boutrand and published by Woodhead Publishing. This book was released on 2019-11-21 with total page 586 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. Presents diverse insights from experts in government, industry and academia Delivers a comprehensive overview of testing and interpreting medical device performance Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market
Book Synopsis Medical Device Regulatory Practices by : Val Theisz
Download or read book Medical Device Regulatory Practices written by Val Theisz and published by CRC Press. This book was released on 2015-08-03 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv
Book Synopsis Healthcare Overview by : Vincenzo Costigliola
Download or read book Healthcare Overview written by Vincenzo Costigliola and published by Springer Science & Business Media. This book was released on 2012-11-06 with total page 522 pages. Available in PDF, EPUB and Kindle. Book excerpt: In healthcare, the realisation of an optimistic prognosis against pessimistic ones depends on current innovations in diagnostic and cost-effective treatment approaches being widely adopted in clinical practice. Utilisation of advanced early and predictive diagnostics, targeted prevention and personalised medical approaches could enable the elderly subpopulation to reach the 100-year age limit in good physical and mental health, as actively contributing members of society. This task requires intelligent political regulations and creation of new guidelines to advance current healthcare systems. In this book, we will collect contributions from several geopolitical regions of Europe, Asia and USA that provide expert opinion on healthcare organisation and outlook as well as economical aspects of personalised medicine.
Book Synopsis Companion and Complementary Diagnostics by : Jan Trøst Jørgensen
Download or read book Companion and Complementary Diagnostics written by Jan Trøst Jørgensen and published by Academic Press. This book was released on 2019-05-08 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt: Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies. Covers all aspects, from biomarker discovery, to development and regulatory approval Explains the "how to" aspects of companion diagnostics Incorporates information on the entire process, allowing for easier and deeper understanding of the topic
Book Synopsis European Regulation of Medical Devices and Pharmaceuticals by : Nupur Chowdhury
Download or read book European Regulation of Medical Devices and Pharmaceuticals written by Nupur Chowdhury and published by Springer Science & Business. This book was released on 2014-04-29 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchical system of rules characterized by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created at both the international and regional level are directly applicable to national legal systems. Also, norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation. In this project the author uses multilevel regulation as a term to characterize a regulatory space in which the process of rule making, rule enforcement and rule adjudication (the regulatory lifecycle) is dispersed across more than one administrative or territorial level and amongst several different actors, both public and private. The author draws on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is non-hierarchical and they may be independent of each other. The lack of central ordering of the regulatory lifecycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for the notion of legal certainty have attracted limited attention from scholars and the demand for legal certainty in regulatory practice is still a puzzle. The book explores the idea of legal certainty in terms of the perceptions and expectations of regulatees in the context of medical products – specifically, pharmaceuticals and medical devices, which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, the book necessarily explores new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies it in the context of multilevel regulation.
Download or read book Microbiology Australia written by and published by . This book was released on 2004-05 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Personalized Medicine by : Nada Bodiroga-Vukobrat
Download or read book Personalized Medicine written by Nada Bodiroga-Vukobrat and published by Springer. This book was released on 2016-10-27 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers comprehensive coverage of the various aspects of personalized medicine as an original approach to classifying, understanding, treating and preventing disease based on individual biological differences. In the introductory section, it defines personalized medicine as a way toward new medical practices and addresses the question: What can personalized medicine offer citizens, medical professionals, reimbursement bodies and stakeholders? Subsequent chapters discuss the technological aspects of personalized medicine: data collection, comprehensive integration and handling of data, together with key enabling factors in developing the requisite technological support for personalized medicine. Lastly, the book explores the main issues shaping the implementation and development of personalized medicine – education, stakeholder participation, infrastructure, a new approach to the classification of disease and medical tests, regulatory frameworks, and new reimbursement models – together with ethical, legal and social issues. Ultimately, the book calls for interdisciplinarity and a radical change in the way we approach the health and wellbeing of individuals. Target groups are medical doctors and researchers in the field of biomedicine, as well as experts from the social sciences dealing with legal, economic and social aspects of health system issues in general. Though the book will primarily benefit these groups of professional experts, its content will also appeal to a far wider readership, as it deals with a paradigm shift in one of society’s main pillars – the health system.
Book Synopsis Medical Regulatory Affairs by : Jack Wong
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.
Book Synopsis Handbook of Medical Device Regulatory Affairs in Asia by : Jack Wong
Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by CRC Press. This book was released on 2018-03-28 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. 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. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
Author :Great Britain: Parliament: House of Commons: European Scrutiny Committee Publisher :The Stationery Office ISBN 13 :0215073088 Total Pages :180 pages Book Rating :4.2/5 (15 download)
Book Synopsis HC 219-I - European Scrutiny Commission First Report of 2014-15 by : Great Britain: Parliament: House of Commons: European Scrutiny Committee
Download or read book HC 219-I - European Scrutiny Commission First Report of 2014-15 written by Great Britain: Parliament: House of Commons: European Scrutiny Committee and published by The Stationery Office. This book was released on 2014-06-20 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Microbiology Australia written by and published by . This book was released on 2004-05 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Mason and McCall Smith's Law and Medical Ethics by : Graeme T. Laurie
Download or read book Mason and McCall Smith's Law and Medical Ethics written by Graeme T. Laurie and published by Oxford University Press. This book was released on 2016 with total page 795 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is an analysis of medical ethical concepts based on legal principles and court decisions, describing what actually happens in practice rather than what should happen and, where there are no precedents available, what is most likely to happen.
Book Synopsis Comprehensive Medicinal Chemistry III by :
Download or read book Comprehensive Medicinal Chemistry III written by and published by Elsevier. This book was released on 2017-06-03 with total page 4609 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comprehensive Medicinal Chemistry III, Eight Volume Set provides a contemporary and forward-looking critical analysis and summary of recent developments, emerging trends, and recently identified new areas where medicinal chemistry is having an impact. The discipline of medicinal chemistry continues to evolve as it adapts to new opportunities and strives to solve new challenges. These include drug targeting, biomolecular therapeutics, development of chemical biology tools, data collection and analysis, in silico models as predictors for biological properties, identification and validation of new targets, approaches to quantify target engagement, new methods for synthesis of drug candidates such as green chemistry, development of novel scaffolds for drug discovery, and the role of regulatory agencies in drug discovery. Reviews the strategies, technologies, principles, and applications of modern medicinal chemistry Provides a global and current perspective of today's drug discovery process and discusses the major therapeutic classes and targets Includes a unique collection of case studies and personal assays reviewing the discovery and development of key drugs
