Read Books Online and Download eBooks, EPub, PDF, Mobi, Kindle, Text Full Free.
A Proposal For A New Regulatory Framework For In Vitro Diagnostic Devices
Download A Proposal For A New Regulatory Framework For In Vitro Diagnostic Devices full books in PDF, epub, and Kindle. Read online A Proposal For A New Regulatory Framework For In Vitro Diagnostic Devices ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
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 Modern Methods of Clinical Investigation by : Institute of Medicine
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.
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 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 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 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 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 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 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 European Union Health Law by : Tamara K. Hervey
Download or read book European Union Health Law written by Tamara K. Hervey and published by Cambridge University Press. This book was released on 2015-11-12 with total page 749 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first holistic and thematic study of EU health law, and its implications, through its own internal logics.
Book Synopsis Food and Drug Administration Advisory Committees by : Institute of Medicine
Download or read book Food and Drug Administration Advisory Committees written by Institute of Medicine and published by National Academies Press. This book was released on 1992-02-01 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.
Book Synopsis Nanotechnology in Medicine by : Mahendra Rai
Download or read book Nanotechnology in Medicine written by Mahendra Rai and published by John Wiley & Sons. This book was released on 2021-10-19 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: NANOTECHNOLOGY IN MEDICINE Discover thorough insights into the toxicology of nanomaterials used in medicine In Nanotechnology in Medicine: Toxicity and Safety, an expert team of nanotechnologists delivers a robust and up-to-date review of current and future applications of nanotechnology in medicine with a special focus on neurodegenerative diseases, cancer, diagnostics, nano-nutraceuticals, dermatology, and gene therapy. The editors offer resources that address nanomaterial safety, which tends to be the greatest hurdle to obtaining the benefits of nanomedicine in healthcare. The book is a one-stop resource for recent and comprehensive information on the toxico logical and safety aspects of nanotechnology used in human health and medicine. It provides readers with cutting-edge techniques for delivering therapeutic agents into targeted cellular compartments, cells, tissues, and organs by using nanoparticulate carriers. The book also offers methodological considerations for toxicity, safety, and risk assessment. Nanotechnology in Medicine: Toxicity and Safety also provides readers with: A thorough introduction to the nanotoxicological aspects of nanomedicine, including translational nanomedicine and nanomedicine personalization Comprehensive introductions to nanoparticle toxicity and safety, including selenium nanoparticles and metallic nanoparticles Practical discussions of nanotoxicology and drug delivery, including gene delivery using nanocarriers and the use of nanomaterials for ocular delivery applications In-depth examinations of nanotechnology ethics and the regulatory framework of nanotechnology and medicine Perfect for researchers, post-doctoral candidates, and specialists in the fields of nanotechnology, nanomaterials, and nanocarriers, Nanotechnology in Medicine: Toxicity and Safety will also prove to be an indispensable part of the libraries of nanoengineering, nanomedicine, and biopharmaceutical professionals and nanobiotechnologists.
Book Synopsis Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by : World Intellectual Property Organization
Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
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.
Author :United States. Congress. Senate. Committee on Governmental Affairs. Subcommittee on Oversight of Government Management Publisher : ISBN 13 : Total Pages :808 pages Book Rating :4.0/5 ( download)
Book Synopsis Health Care Financing Administration's Management of Medical Laboratories by : United States. Congress. Senate. Committee on Governmental Affairs. Subcommittee on Oversight of Government Management
Download or read book Health Care Financing Administration's Management of Medical Laboratories written by United States. Congress. Senate. Committee on Governmental Affairs. Subcommittee on Oversight of Government Management and published by . This book was released on 1988 with total page 808 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 280 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 Regulatory Aspects of Gene Therapy and Cell Therapy Products by : Maria Cristina Galli
Download or read book Regulatory Aspects of Gene Therapy and Cell Therapy Products written by Maria Cristina Galli and published by Springer Nature. This book was released on 2023-08-01 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the different regulatory pathways for Advanced Therapy Medicinal Products implemented by national agencies in North and South America, Europe and Asia and by international bodies in the effort of international harmonization. This book represents an update of the first edition, as it covers regulatory novelties and accumulated experience in the regions already addressed. In addition, this new edition offers a wider international perspective: new chapters are included covering Advanced Therapy Medicinal Products regulations in India, Malaysia, Spain and Thailand, the European Pharmacopoeia texts for gene therapy medicinal products as well as international harmonization programs. Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure and therapeutic use of these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of Advanced Therapy Medicinal Products in the areas of product quality, pharmacology and toxicology, clinical trial design and HTA pathways, as well as pertinent ‘must-know’ guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: a Global Perspective is part of the American Society of Gene & Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
