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Author : National Coordinating Committee for Therapeutic Goods In Vitro Diagnostic Device Working Group (Australia)
Publisher : Unknown
Page : 74 pages
File Size : 49,5 Mb
Release : 2003
Category : Electronic
ISBN : 1920746056
Author : World Health Organization
Publisher : World Health Organization
Page : 73 pages
File Size : 54,9 Mb
Release : 2019-05-16
Category : Medical
ISBN : 9789241210263
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.
Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Page : 241 pages
File Size : 45,9 Mb
Release : 1990-02-01
Category : Medical
ISBN : 9780309042864
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 : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
Page : 586 pages
File Size : 53,8 Mb
Release : 2019-11-21
Category : Medical
ISBN : 9780081026441
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
Author : Vincenzo Costigliola
Publisher : Springer Science & Business Media
Page : 522 pages
File Size : 55,8 Mb
Release : 2012-11-06
Category : Medical
ISBN : 9789400746022
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.
Author : Nupur Chowdhury
Publisher : Springer Science & Business
Page : 190 pages
File Size : 43,7 Mb
Release : 2014-04-29
Category : Law
ISBN : 9783319045948
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 : Val Theisz
Publisher : CRC Press
Page : 590 pages
File Size : 45,9 Mb
Release : 2015-08-03
Category : Medical
ISBN : 9789814669115
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 effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Publisher : National Academies Press
Page : 442 pages
File Size : 44,6 Mb
Release : 2011-04-03
Category : Medical
ISBN : 9780309158060
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.
Author : Nada Bodiroga-Vukobrat,Daniel Rukavina,Krešimir Pavelić,Gerald G. Sander
Publisher : Springer
Page : 278 pages
File Size : 47,7 Mb
Release : 2016-10-27
Category : Law
ISBN : 9783319393490
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.
Author : Jack Wong,Raymond Tong
Publisher : CRC Press
Page : 494 pages
File Size : 44,7 Mb
Release : 2018-03-28
Category : Medical
ISBN : 9780429996764
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 : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 318 pages
File Size : 55,7 Mb
Release : 2011-10-25
Category : Medical
ISBN : 9780309212458
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.
Author : Great Britain: Parliament: House of Commons: European Scrutiny Committee
Publisher : The Stationery Office
Page : 180 pages
File Size : 41,8 Mb
Release : 2014-06-20
Category : Political Science
ISBN : 9780215073082
Author : Marise Cremona
Publisher : Oxford University Press
Page : 272 pages
File Size : 46,8 Mb
Release : 2017-06-23
Category : Law
ISBN : 9780192534033
What is the nature of the relationship between the fields of new technology and EU law? What challenges do new technologies pose for the internal market and the fundamental principles of the EU? The first part of the collection explores the EU's approach to the regulation of scientific and technological risk, and the link between the regulation of technology and the internal market. In detail, the chapters analyse the interaction between EU law, bioethics and medical and health technologies. The second part of the collection enhances on this, and the chapters scrutinize specific policy areas in order to explain the alternate ways in which EU policy and technology cooperate.
Author : Santa Slokenberga,Timo Minssen,Ana Nordberg
Publisher : BRILL
Page : 319 pages
File Size : 42,8 Mb
Release : 2023-03-06
Category : Law
ISBN : 9789004526136
This edited collection examines the ethical, legal, social and policy implications of genome editing technologies. Moreover, it offers a broad spectrum of timely legal analysis related to bringing genome editing to the market and making it available to patients, including addressing genome editing technology regulation through procedures for regulatory approval, patent law and competition law. In twelve chapters, this volume offers persuasive arguments for justifying transformative regulatory interventions regarding human genome editing, as well as the various legal venues for introducing necessary or desirable changes needed to create an environment for realizing the potential of genome editing technology for the benefit of patients and society.
Author : Great Britain: Parliament: House of Commons: Science and Technology Committee
Publisher : The Stationery Office
Page : 110 pages
File Size : 47,9 Mb
Release : 2012-11
Category : Medical
ISBN : 0215049748
EU regulations on the safety of medical implants-such as metal-on-metal hip replacements-must be urgently tightened in response to evidence that manufacturers are seeking approval for devices in Member States with the least stringent regulatory regimes. Much greater transparency is needed about the approval process so patients and doctors can have full confidence in the implants they are using. Manufacturers and regulators must also publish more rigorous clinical data on the safety of new implants and be subject to greater scrutiny. The clinical data requirements for high-risk medical devices to be sold on the European Market are much less stringent than for new medicines. There appears to be reliance on equivalence-similarity to an existing implant-rather than clinical investigations of the implant being approved. The Committee calls for all clinical data used in the approval of a medical implant to be published without identifying patients or clinical trial participants. For products currently on the market, such data should be published immediately. There should also be a public record of every approach from a manufacturer to any notified body in the EU so that 'forum shopping' can be identified. UK regulatory body the Medicines and Healthcare products Regulatory Agency (MHRA) is criticised for its slow reaction to reports of problems with metal-on-metal hip replacements in Australia. The withdrawal of PIP breast implants also highlights the need for frequent and unannounced spot-checks of medical implant manufacturers to identify and prevent similar problems. The Committee is supportive of the proposed legislative changes from the European Commission to improve transparency