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The Medicines For Human Use Clinical Trials Amendment Eu Exit Regulations 2019
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Book Synopsis Medicine, patients and the law by : Emma Cave
Download or read book Medicine, patients and the law written by Emma Cave and published by Manchester University Press. This book was released on 2023-06-06 with total page 729 pages. Available in PDF, EPUB and Kindle. Book excerpt: Embryo research, cloning, assisted conception, neonatal care, pandemic vaccine development, saviour siblings, organ transplants, drug trials – modern developments have transformed the field of medicine almost beyond recognition in recent decades and the law struggles to keep up. In this highly acclaimed and very accessible book Margaret Brazier, Emma Cave and Rob Heywood provide an incisive survey of the legal situation in areas as diverse as fertility treatment, patient consent, assisted dying, malpractice and medical privacy. The seventh edition of this book has been fully revised and updated to cover the latest cases, Brexit-related regulatory reform and COVID-19 pandemic measures. Essential reading for healthcare professionals, lecturers, medical and law students, this book is of relevance to all whose perusal of the daily news causes wonder, hope and consternation at the advances and limitations of medicine, patients and the law.
Book Synopsis Technology Transfer by : Mark Anderson
Download or read book Technology Transfer written by Mark Anderson and published by Bloomsbury Publishing. This book was released on 2020-03-20 with total page 1123 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers the laws surrounding commercial transactions that involve the development, use of commercialisation of technology and associate intellectual property rights. Types of transactions that fall within this category are research and development contracts and intellectual property licences and these form the main focus of the book. Written by experts and describing the many different areas of law that affect technology agreements such as IP, contract law, competition law and tax, this is the leading guide to this complex area of law. The new Fourth Edition has been brought completely up to date including: - Coverage of EU Horizon 2020 replacing Framework 7 funding scheme - General Data Protection Regulation (GDPR) - Updates in line with the Charities Act 2011 - New section on different types of standard agreements available (Lambert, NIHR, EU consortium agreements) - New material dealing with variety of relevant patent legislation: Unitary Patent and Unified Patents Court, the Intellectual Property Act 2014, Legislative Reform (Patents) Order 2014, Patents (Supplementary Protection Certificates) Regulations) 2014 - New material on the EU Trade Secrets Directive - Coverage of Regulations No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Addition of research exception (new section 22A) from freedom of information from 1 October 2014 (Freedom of Information Act 2014) - Coverage of Technology Transfer Regulation, 316/2014 and related guidelines
Book Synopsis Law and Ethics for Paramedics by : Georgette Eaton
Download or read book Law and Ethics for Paramedics written by Georgette Eaton and published by Class Professional Publishing. This book was released on 2023-12-12 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: In order to tackle ethical and legal intricacies with confidence, it is paramount that paramedics acquire firm understanding and knowledge as a foundation for their practice. This essential guide equips you with the expertise needed to adeptly navigate these complexities, enabling you to address them with assurance when they arise. With contributions from experienced paramedic authors, each chapter skilfully amalgamates the crucial principles of ethical thinking and UK law. This expanded third edition has also been meticulously updated with the latest case law and legislative changes. It presents revised ethical considerations, providing valuable insights to enhance your day-to-day practice and empower you to make sound judgements, while real-world examples ensure relevance and applicability to your professional journey. With this book at your side, you will be able to successfully navigate the legal and ethical landscape you are faced with, helping you make a positive impact to patient care and reinforcing your commitment to professional excellence. Key features: • Brand new content on applied ethics, the role of the coroner’s court in England and Wales and patients’ refusal of blood products. • Robustly evidence-based with updated case law throughout. • Clear explanations of complex topics such as mental capacity, mental health, medical treatment of children and organ donation. • Case studies to help you apply your knowledge to the real world. • Aligned to the Health and Care Professions Council’s standards of proficiency for paramedics, to give you the confidence you need to deliver safe and professional patient care.
Book Synopsis Clinical Negligence by : Dr Michael Powers KC
Download or read book Clinical Negligence written by Dr Michael Powers KC and published by Bloomsbury Publishing. This book was released on 2023-07-31 with total page 1609 pages. Available in PDF, EPUB and Kindle. Book excerpt: "I would highly recommend this book...It is high quality, clear and comprehensive and will no doubt prove an invaluable source of reference. Five stars on all counts." Tim Kevan, co-editor, PIBULJ.COM This book remains the only text of its kind to cover both the medical and legal aspects of medical negligence. Written by a team of more than 60 experts, it continues to provide the most comprehensive and authoritative guidance on all aspects of clinical negligence claims, from bringing an action for damages to presenting expert evidence in court. It also includes detailed consideration of funding and cost implications. Those needing clear guidance to make the best possible preparations for an action will find all they need here. The new 6th edition has been fully revised and restructured, including new chapters on the future of clinical negligence litigation, cardiology, gynaecology, obstetrics, haematology , and also includes coverage and analysis of recent key cases such as: - Williams v Bermuda Hospitals [2016] UKPC 4 (causation) - R (on the application of Maughan) v HM Senior Coroner for Oxfordshire [2020] UKSC 46 (suicide in inquests) - Darnley v Croydon Health Authority [2018] UKSC 50 (duty of care owed by receptionist) - ABC v St George's Hosp [2020] EWHC 455 (Huntington's chorea confidentiality) - Swift v Carpenter [2020] EWCA Civ 1295 (future accommodation costs) - Whittington Hospital NHS Trust v XX [2020] UKSC 14 (damages for surrogacy) - Khan v Meadows [2021] UKSC 21 (scope of duty of care) - Nguyen v HM Assistant Coroner for Inner West London [2021] EWHC 3354 (sufficiency of inquiry) Easy-to-access structure The new edition maintains its easy-to-access, two-part structure. The first part, set out in 16 chapters, deals with legal aspects of medical malpractice, including complaints procedures, poor performance and medical professional governance, preparation of medical evidence, settlements and trial. There are also chapters on product liability, and coronial law. The final 27 chapters in the second part cover the risks associated with particular areas of specialist medical practice. This title is included in Bloomsbury Professional's Clinical Negligence online service.
Book Synopsis Mason and Mccall Smith's Law and Medical Ethics by :
Download or read book Mason and Mccall Smith's Law and Medical Ethics written by and published by Oxford University Press. This book was released on 2023-07-10 with total page 699 pages. Available in PDF, EPUB and Kindle. Book excerpt: Trusted for over 40 years for its authoritative account of medical law, this text provides the right balance between in-depth legal coverage and analysis of ethical issues.This classic textbook focuses on medical law and its relationship with medical practice and modern ethics. It provides thorough coverage of all topics found on medical law courses, and in-depth analysis of recent court decisions and legislation, encouraging students to thinkcritically about this area of study. - Covers the whole field of modern ethical medical practice, making the book suitable for use on all undergraduate and postgraduate medicallaw courses- Clearly sets a diversity of views in ethical debates, and offers the authors' own perspectives, encouraging students to explore and form their own opinions- Takes account of the influence of international policy and legal developments in shaping medical law in the UKNew to this edition:· Two brand new chapters introduce students to concepts, theories, and tools that frame interpretation and analysis ofhealth and medical law· A new chapter provides an overview of UK health systems and examines these in the context of devolution, the Covid-19 pandemic, and Brexit· The table of contents has beenreorganised and streamlined to enhance clarity and focus on current issues in the discipline· Includes coverage of developments such as the Health and Social Care Act 2022, Mental Health Bill 2022, Medicines and Medical Devices Act 2021, Coronavirus Act 2020, new regimes for organ donation, Bell v Tavistock, ABC v St George's Healthcare NHS Trust, Khan v Meadows, and moreDigital formatsThis twelfth edition is availablefor students and institutions to purchase in a variety of formats.The e-book offers a mobile experience and convenient access along with functionality tools, navigation features, and links that offer extra learningsupport: www.oxfordtextbooks.co.uk/ebooks
Book Synopsis GDPR and Biobanking by : Jane Reichel
Download or read book GDPR and Biobanking written by Jane Reichel and published by Springer Nature. This book was released on 2021 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part I Setting the scene -- Introduction: Individual rights, the public interest and biobank research 4000 (8) -- Genetic data and privacy protection -- Part II GDPR and European responses -- Biobank governance and the impact of the GDPR on the regulation of biobank research -- Controller' and processor's responsibilities in biobank research under GDPR -- Individual rights in biobank research under GDPR -- Safeguards and derogations relating to processing for archiving purposes in the scientific purposes: Article 89 analysis for biobank research -- A Pan-European analysis of Article 89 implementation and national biobank research regulations -- EEA, Switzerland analysis of GDPR requirements and national biobank research regulations -- Part III National insights in biobank regulatory frameworks -- Selected 10-15 countries for reports: Germany -- Greece -- France -- Finland -- Sweden -- United Kingdom -- Part IV Conclusions -- Reflections on individual rights, the public interest and biobank research, ramifications and ways forward. .
Book Synopsis Strengthening Forensic Science in the United States by : National Research Council
Download or read book Strengthening Forensic Science in the United States written by National Research Council and published by National Academies Press. This book was released on 2009-07-29 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scores of talented and dedicated people serve the forensic science community, performing vitally important work. However, they are often constrained by lack of adequate resources, sound policies, and national support. It is clear that change and advancements, both systematic and scientific, are needed in a number of forensic science disciplines to ensure the reliability of work, establish enforceable standards, and promote best practices with consistent application. Strengthening Forensic Science in the United States: A Path Forward provides a detailed plan for addressing these needs and suggests the creation of a new government entity, the National Institute of Forensic Science, to establish and enforce standards within the forensic science community. The benefits of improving and regulating the forensic science disciplines are clear: assisting law enforcement officials, enhancing homeland security, and reducing the risk of wrongful conviction and exoneration. Strengthening Forensic Science in the United States gives a full account of what is needed to advance the forensic science disciplines, including upgrading of systems and organizational structures, better training, widespread adoption of uniform and enforceable best practices, and mandatory certification and accreditation programs. While this book provides an essential call-to-action for congress and policy makers, it also serves as a vital tool for law enforcement agencies, criminal prosecutors and attorneys, and forensic science educators.
Book Synopsis WHO guideline on country pharmaceutical pricing policies by :
Download or read book WHO guideline on country pharmaceutical pricing policies written by and published by World Health Organization. This book was released on 2020-09-29 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.
Book Synopsis Human Germline Genome Modification and the Right to Science by : Andrea Boggio
Download or read book Human Germline Genome Modification and the Right to Science written by Andrea Boggio and published by Cambridge University Press. This book was released on 2022-06-30 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The advent of the CRISPR/Cas9 class of genome editing tools is transforming not just science and medicine, but also law. When the genome of germline cells is modified, the modifications could be inherited, with far-reaching effects in time and scale. Legal systems are struggling with keeping up with the CRISPR revolution and both lawyers and scientists are often confused about existing regulations. This book contains an analysis of the national regulatory framework in eighteen selected countries. Written by national legal experts, it includes all major players in bioengineering, plus an analysis of the emerging international standards and a discussion of how international human rights standards should inform national and international regulatory frameworks. The authors propose a set of principles for the regulation of germline engineering, based on international human rights law, that can be the foundation for regulating heritable gene editing both at the level of countries as well as globally.
Book Synopsis Law and Legacy in Medical Jurisprudence by : Edward S. Dove
Download or read book Law and Legacy in Medical Jurisprudence written by Edward S. Dove and published by Cambridge University Press. This book was released on 2022-03-10 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Graeme Laurie stepped down from the Chair in Medical Jurisprudence at the University of Edinburgh in 2019. This edited collection pays tribute to his extraordinary contributions to the field. Graeme often spoke about the importance of 'legacy' in academic work and forged a remarkable intellectual legacy of his own, notably through his work on genetic privacy, human tissue and information governance, and the regulatory salience of the concept of liminality. The essays in this volume animate the concept of legacy to analyse the study and practice of medical jurisprudence. In this light, legacy reveals characteristics of both benefit and burden, as both an encumbrance to and facilitator of the development of law, policy and regulation. The contributions reconcile the ideas of legacy and responsiveness and show that both dimensions are critical to achieve and sustain the health of medical jurisprudence itself as a dynamic, interdisciplinary and policy-engaged field of thinking.
Book Synopsis WHO Guidelines on Hand Hygiene in Health Care by : World Health Organization
Download or read book WHO Guidelines on Hand Hygiene in Health Care written by World Health Organization and published by World Health Organization. This book was released on 2009 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The WHO Guidelines on Hand Hygiene in Health Care provide health-care workers (HCWs), hospital administrators and health authorities with a thorough review of evidence on hand hygiene in health care and specific recommendations to improve practices and reduce transmission of pathogenic microorganisms to patients and HCWs. The present Guidelines are intended to be implemented in any situation in which health care is delivered either to a patient or to a specific group in a population. Therefore, this concept applies to all settings where health care is permanently or occasionally performed, such as home care by birth attendants. Definitions of health-care settings are proposed in Appendix 1. These Guidelines and the associated WHO Multimodal Hand Hygiene Improvement Strategy and an Implementation Toolkit (http://www.who.int/gpsc/en/) are designed to offer health-care facilities in Member States a conceptual framework and practical tools for the application of recommendations in practice at the bedside. While ensuring consistency with the Guidelines recommendations, individual adaptation according to local regulations, settings, needs, and resources is desirable. This extensive review includes in one document sufficient technical information to support training materials and help plan implementation strategies. The document comprises six parts.
Book Synopsis Digital Contact Tracing for Pandemic Response by : Jeffrey P. Kahn
Download or read book Digital Contact Tracing for Pandemic Response written by Jeffrey P. Kahn and published by . This book was released on 2020 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Technologies of digital contact tracing have been used in several countries to help in the surveillance and containment of COVID-19. These technologies have promise, but they also raise important ethical, legal, and governance challenges that require comprehensive analysis in order to support decision-making. Johns Hopkins University recognized the importance of helping to guide this process and organized an expert group with members from inside and outside the university. This expert group urges a stepwise approach that prioritizes the alignment of technology with public health needs, building choice into design architecture and capturing real-world results and impacts to allow for adjustments as required"--
Book Synopsis The Law of Off-label Uses of Medicines by : Andrea Parziale
Download or read book The Law of Off-label Uses of Medicines written by Andrea Parziale and published by Taylor & Francis. This book was released on 2022-08-12 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarifies the regulatory mechanisms and litigation trends concerning off-licence prescriptions in these jurisdictions. It assesses how traditional, prevention-driven regulatory and civil liability rules are being adapted to tackle potential risks and scientific uncertainty. The book outlines the applicable regulations, as well as considering Brexit’s impact on off-label policies in the UK, and EU and national off-label policies in the context of the fight against the Covid-19 pandemic. It also explores under what conditions physicians, manufacturers, or regulators must compensate patients injured by untested prescriptions. The book will be an essential resource for researchers, academics and policy-makers working in the areas of medical law and ethics, public health law, pharmaceutical law and private comparative law.
Book Synopsis Inhaled Medicines by : Stavros Kassinos
Download or read book Inhaled Medicines written by Stavros Kassinos and published by Academic Press. This book was released on 2021-02-05 with total page 438 pages. Available in PDF, EPUB and Kindle. Book excerpt: Inhaled medicines are widely used to treat pulmonary and systemic diseases. The efficacy and safety of these medicines can be influenced by the deposited fraction, the regional deposition pattern within the lungs and by post-depositional events such as drug dissolution, absorption and clearance from the lungs. Optimizing performance of treatments thus requires that we understand and are able to quantify these product and drug attributes. Inhaled Medicines: Optimizing Development through Integration of In Silico, In Vitro and In Vivo Approaches explores the current state of the art with respect to inhalation drug delivery, technologies available to assess product performance, and novel in silico methods now available to link in vitro product performance to clinical performance. Recent developments in the latter field, especially the prospect of integration of three-dimensional Computational Fluid Particle Methods (3D-CFPD) with physiologically based pharmacokinetic (PBPK models), unlocks the potential for in silico population studies that can help inform and optimize treatment and product development strategies. In this highly multidisciplinary field, where progress occurs at the intersection of several disciplines of engineering and science, this work aims to integrate current knowledge and understanding and to articulate a clear vision for future developments. ? Considers the healthcare needs driving the field, and where inhaled drugs could have the maximum impact ? Gives a concise account of the state of the art in key areas and technologies such as device and formulation technologies, clinically relevant in vitro performance assessment, medical imaging, as well as in silico modelling and simulation ? Articulates how the combination of in vitro product performance data, medical imaging and simulations technologies in the framework of large scale in silico pre-clinical trials could revolutionize the field ? Provides systematic and thorough referencing to sources offering a more-in-depth analysis of technical issues
Book Synopsis The Business of Healthcare Innovation by : Lawton Robert Burns
Download or read book The Business of Healthcare Innovation written by Lawton Robert Burns and published by Cambridge University Press. This book was released on 2005-08-25 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Business of Healthcare Innovation is the first wide-ranging analysis of business trends in the manufacturing segment of the health care industry. In this leading edge volume, Professor Burns focuses on the key role of the 'producers' as the main source of innovation in health systems. Written by professors of the Wharton School and industry executives, this book provides a detailed overview of the pharmaceutical, biotechnology, genomics/proteomics, medical device and information technology sectors. It analyses the market structures of these sectors as well as the business models and corporate strategies of firms operating within them. Most importantly, the book describes the growing convergence between these sectors and the need for executives in one sector to increasingly draw upon trends in the others. It will be essential reading for students and researchers in the field of health management, and of great interest to strategy scholars, industry practitioners and management consultants.
Book Synopsis INSPIRE Handbook by : World Health Organization
Download or read book INSPIRE Handbook written by World Health Organization and published by World Health Organization. This book was released on 2019-02-26 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: INSPIRE is a resource to help governments, international agencies, and non-government organisations prevent and respond to violence against children. It was developed by 10 international and U.S.-based agencies and includes strategy documents and implementation tools. This handbook provides guidance on how to choose and implement interventions based on specific needs and context, and is organised around the 7 key INSPIRE strategies: implementation and enforcement of laws; norms and values; safe environments; parent and caregiver support; income and economic strengthening; response and support services; and education and life skills. The handbook also provides an overview of implementation and impact indicators, drawn from the companion document 'INSPIRE indicator guidance and results framework'.
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 2011-11-25 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.
