Download or read book Diagnostics at a Crossroads Navigating IVD Regulation in a Changing Environment written by Jeffrey Gibbs and published by . This book was released on 2020-12-20 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices written by World Health Organization and published by . This book was released on 2017-05-09 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.
Download or read book The selection and use of essential in vitro diagnostics written by and published by World Health Organization. This book was released on 2021-01-29 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Medical Devices and IVDs written by Wolfgang Ecker and published by BoD – Books on Demand. This book was released on 2022-03-25 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: With this book, you get a really complete seminar for the new Regulations on medical devices and IVDs in the EU, ready at hand, at any time. These EU regulations create new rules for medical technology and laboratory diagnostics in Europe. Concise regulatory know-how is now required to keep or reposition medical devices and in vitro diagnostics on the European market, from syringes, contact lenses, medical device apps, pregnancy tests, nuclear magnetic resonance tomography to cancer tests, genetic diagnostics, HIV tests, hip implants, heart catheters, artificial spinal discs, stents and pacemakers. Concise regulatory training and further education of employees in companies and health care facilities is the order of the day. This also applies to biomedical and medical technology students at universities of applied sciences and biomedical universities, start-ups and spin-offs, who must make use of this know-how from the initial product idea through the further stages of product development to market access. The book provides a thorough, compact course on the new regulations, starting with perfect overview and easy navigation and going into depth where you need it: this book will make you fit and confident for the new European challenges! 344 pages; 47 col. figures; 26 tables
Download or read book Development of National Health Laboratory Policy and Plan written by WHO Regional Office for South-East Asia and published by . This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides technical support to Member States in the South-East Asia and Western Pacific Regions on the steps required to develop and effectively implement a national laboratory policy and national laboratory plan in accordance with the Asia Pacific Strategy for Strengthening Health Laboratory Services (2010-2015). The document provides a structure for developing a comprehensive policy and regulatory framework for establishing, operating and monitoring the health laboratory services, and promoting better coordination of activities among health programs and institutions for efficient support to both clinical and public health services.
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.
Download or read book In Vitro Diagnostic Industry in China written by Haibo Song and published by Springer Nature. This book was released on 2021-07-28 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book systematically describes the achievements and current situation of in vitro diagnostic (IVD) industry in China. It consists of eight parts, including the overview on the IVD industry in China in 2019, hot technologies and products of IVD industry, academic, technological and product development in the field of IVD, such as biochemical diagnosis, immune-diagnosis, molecular diagnosis, blood and body fluid diagnosis, microbial detection, point-of-care testing, laboratory assembly line, etc. This book is compiled by an editorial committee composed of well-known entrepreneurs, experts and professors in IVD industry in China. It is a reference book for practitioners of IVD industry, medical laboratory and medical staffs all over the world.
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.
Download or read book Clinical Evaluation and Investigation of Medical Devices under the new EU Regulation written by Wolfgang Ecker and published by BoD – Books on Demand. This book was released on 2020-06-04 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concept of clinical evaluation and the framework for clinical investigations have been significantly enforced within the new EU-Medical Device Regulation (MDR). This book provides in-depth and practice-oriented guidance on the systematic identification and generation of clinical data through clinical investigations and other relevant sources. It addresses the needs of all stakeholders, be it manufacturers, notified bodies or competent authorities, when they have to plan, perform or assess clinical evaluations and investigations for medical devices on the way to conformity assessment and CE marking. It is a valuable tool of qualification for clinicians and related experts when preparing for a role of a clinical evaluator in the field, either when serving any of the stakeholders or when trying to make their own involvement stand out in start-ups. spin-offs or other development projects or in counselling services.
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.
Download or read book Medical Device Use Error written by Michael Wiklund and published by CRC Press. This book was released on 2016-01-06 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Use Error: Root Cause Analysis offers practical guidance on how to methodically discover and explain the root cause of a use error-a mistake-that occurs when someone uses a medical device. Covering medical devices used in the home and those used in clinical environments, the book presents informative case studies about the use errors
Download or read book Biomarkers Diagnostics and Precision Medicine in the Drug Industry written by Abdel Halim and published by Academic Press. This book was released on 2019-06-08 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: The high failure rate in the pharmaceutical industry has positioned biomarkers and personalized medicine in the frontline, as possible solutions. If executed right, biomarkers and companion diagnostics (CDx) can potentially help the drug industry enhance the probability of success, accelerate the time to market, and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most effective and least toxic therapies. This book aims to examine the challenges and limitations in biomarkers and laboratory tests. It also offers advice on best practices to ensure proper application of biomarkers and bridges the gap between diagnostic business development claims and real-life deliverables. The book covers biomarkers for different purposes, provides examples from different technologies, which includes standard-of-care approved assays as well as for-investigational-use and for-research-use-only assays. It also includes new data for biomarkers in different therapeutic indications and offers case studies and practical examples. This book serves as a reference to drug developers, IVD providers, clinical labs, healthcare givers, academicians, and researchers for best practices to help increase the probability of success in drug development and improve patient management. - Provides the unique insight of an expert with extensive experience in diagnostics and clinical laboratory on one side and drug discovery and development on the other side - Addresses the challenges of drug development and precision medicine and suggests how to eliminate or mitigate these challenges through better utilization of biomarkers and diagnostics in drug development and patient management - Features case studies and real-life examples from different classes of biomarkers on different platforms for different therapeutic areas and includes more than 200 illustrations
Download or read book An Overview of FDA Regulated Products written by Eunjoo Pacifici and published by Academic Press. This book was released on 2018-06-13 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations
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
Download or read book Companion Diagnostics CDx in Precision Medicine written by Il-Jin Kim and published by CRC Press. This book was released on 2019-03-06 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is a new trend in anti-cancer therapeutics development: a targeted therapy and precision medicine that targets a subgroup of patients with specific biomarkers. An in vitro diagnostic (IVD) assay is required to identify a subgroup of cancer patients who would benefit from the targeted therapy, or not likely benefit, or have a high risk of side effects from the specific drug treatment. This IVD or medical device is called a companion diagnostic (CDx) assay. It is key to have a robust CDx assay or device for the success of targeted therapy and precision medicine. This book covers the technical, historical, clinical, and regulatory aspects of CDx in precision medicine. Clearly, more and more newly developed oncology drugs will require accompanying CDx assays, and this book, with chapters contributed by renowned oncologists, provides a comprehensive foundation for the knowledge and application of CDx for precision medicine.
Download or read book Nanopharmaceutics written by Xing-Jie Liang and published by World Scientific. This book was released on 2013 with total page 605 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nanomaterials, with their unique size-dependent physical and chemical properties, have shown promising advantages as drug and gene delivery vehicles, ultra-sensitive intracellular detectors and novel therapeutic drugs. Nanopharmaceutics is one of the disciplines that will benefit the most from this technology.Nanotechnology will have a revolutionary impact on cancer diagnosis and therapy due to the exceptional characteristics of nanopharmaceutics.This book provides an overview of some tools, methods, and materials of nanotechnology that offer potential applications in pharmaceutics, followed by a series of examples showing applications that are already in development. It may very well inspire researchers to develop a new generation of pharmaceutics with inventive non-traditional approach and employ nanoscale science for the benefit of the patient.
Download or read book The Handbook of Biomarkers written by Kewal K. Jain and published by Springer Science & Business Media. This book was released on 2010-02-06 with total page 509 pages. Available in PDF, EPUB and Kindle. Book excerpt: Of the thousands of biomarkers that are currently being discovered, relatively few are being validated for further applications, and the potential of a biomarker can be quite difficult to evaluate. To aid in this imperative research, Dr. Kewal K. Jain’s Handbook of Biomarkers thoroughly describes many different types of biomarkers and their discovery using various "-omics" technologies, such as proteomics and metabolomics, along with the background information needed for the evaluation of biomarkers as well as the essential procedures for their validation and use in clinical trials. With biomarkers described first according to technologies and then according to various diseases, this detailed book features the key correlations between diseases and classifications of biomarkers, which provides the reader with a guide to sort out current and future biomarkers. Comprehensive and cutting-edge, The Handbook of Biomarkers serves as a vital guide to furthering our understanding of biomarkers, which, by facilitating the combination of therapeutics with diagnostics, promise to play an important role in the development of personalized medicine, one of the most important emerging trends in healthcare today.
