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The Medicines For Human Use Clinical Trials Regulations 2004
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Book Synopsis Principles of Good Clinical Practice by : Michael J. McGraw
Download or read book Principles of Good Clinical Practice written by Michael J. McGraw and published by Pharmaceutical Press. This book was released on 2010 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Book Synopsis Regulatory Stewardship of Health Research by : Edward S. Dove
Download or read book Regulatory Stewardship of Health Research written by Edward S. Dove and published by Edward Elgar Publishing. This book was released on 2020-02-28 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: This timely book examines the interaction of health research and regulation with law through empirical analysis and the application of key anthropological concepts to reveal the inner workings of human health research. Through ground-breaking empirical inquiry, Regulatory Stewardship of Health Research explores how research ethics committees (RECs) work in practice to both protect research participants and promote ethical research. This thought-provoking book provides a new perspective on the regulation of health research by demonstrating how RECs and other regulatory actors seek to fulfil these two functions by performing a role of ‘regulatory stewardship’.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309498635 Total Pages :169 pages Book Rating :4.3/5 (94 download)
Book Synopsis Regulating Medicines in a Globalized World by : National Academies of Sciences, Engineering, and Medicine
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Book Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine
Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
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. This book was released on 2015-09-15 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). 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 for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, 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 and 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.
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 The Doctor's Handbook by : Tony White
Download or read book The Doctor's Handbook written by Tony White and published by Radcliffe Publishing. This book was released on 2010 with total page 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: Previously published as The Specialist Registrar and New Consultant Handbook, these completely revised and reconfigured volumes reflect the changing everyday work of specialist trainees, registrars and consultants. The two volumes of The Doctors Handbook are an essential reference for all doctors, from specialist trainees to consultants.
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 Introduction to Research Methodology for Specialists and Trainees by : P. M. Shaughn O'Brien
Download or read book Introduction to Research Methodology for Specialists and Trainees written by P. M. Shaughn O'Brien and published by Cambridge University Press. This book was released on 2017-08-17 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health-centred research has changed hugely over the last ten years, from the importance of computing software to the NHS becoming more involved in research. The expectations of grant-awarding bodies, ethics committees and publishers have evolved and increased in many senses. This new edition is designed for trainee clinicians, not only those preparing for membership of the Royal College of Obstetricians and Gynaecologists (MRCOG) but also higher degree candidates and aspiring clinical academics. Chapter authors with extensive expertise make the path to embarking on research direct, straightforward and most importantly, fun and interesting, particularly aiming to support those who trained clinically and are now undertaking a research project or beginning an academic career. There remains no single book with so much relevant information gathered in a single, succinct volume. This edition now covers the wide spectrum of modern research methods for all specialities, with five supplementary chapters on major obstetric and gynaecological subspecialties.
Book Synopsis Reviewing Clinical Trials by : Chinese University of Hong Kong
Download or read book Reviewing Clinical Trials written by Chinese University of Hong Kong and published by . This book was released on 2010 with total page 153 pages. Available in PDF, EPUB and Kindle. Book excerpt: The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.
Book Synopsis Textbook of Clinical Trials by : David Machin
Download or read book Textbook of Clinical Trials written by David Machin and published by John Wiley & Sons. This book was released on 2007-01-11 with total page 784 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now published in its Second Edition, the Textbook of Clinical Trials offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume. Praise for the First Edition: "... very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas." BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005 The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues. The Textbook of Clinical Trials, Second Edition: Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network An invaluable resource for pharmaceutical companies, the Textbook of Clinical Trials, Second Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike.
Book Synopsis Law and the Regulation of Medicines by : Emily Jackson
Download or read book Law and the Regulation of Medicines written by Emily Jackson and published by Bloomsbury Publishing. This book was released on 2012-03-01 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt: The principal purpose of this book is to tell the story of a medicine's journey through the regulatory system in the UK, from defining what counts as a medicine, through clinical trials, licensing, pharmacovigilance, marketing and funding. The question of global access to medicines is addressed because of its political importance, and because it offers a particularly stark illustration of the consequences of classifying medicines as a private rather than a public good. Two further specific challenges to the future of medicine's regulation are examined separately: first, pharmacogenetics, or the genetic targeting of medicines to subgroups of patients, and second, the possibility of using medicines to enhance well-being or performance, rather than treat disease. Throughout, the emphasis is on the role of regulation in shaping and influencing the operation of the medicines industry, an issue that is of central importance to the promotion of public health and the fair and equitable distribution of healthcare resources.
Book Synopsis Drug Discovery and Evaluation: Methods in Clinical Pharmacology by : H.Gerhard Vogel
Download or read book Drug Discovery and Evaluation: Methods in Clinical Pharmacology written by H.Gerhard Vogel and published by Springer Science & Business Media. This book was released on 2010-12-15 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".
Author :Great Britain: Parliament: House of Commons: Health Committee Publisher :The Stationery Office ISBN 13 :9780215024572 Total Pages :556 pages Book Rating :4.0/5 (245 download)
Book Synopsis The Influence of the Pharmaceutical Industry by : Great Britain: Parliament: House of Commons: Health Committee
Download or read book The Influence of the Pharmaceutical Industry written by Great Britain: Parliament: House of Commons: Health Committee and published by The Stationery Office. This book was released on 2005-04-26 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: Incorporating HC 1030-i to iii.
Author :Council for International Organizations of Medical Sciences (CIOMS) Publisher :World Health Organization ISBN 13 :9789290360889 Total Pages :0 pages Book Rating :4.3/5 (68 download)
Book Synopsis International Ethical Guidelines for Health-Related Research Involving Humans by : Council for International Organizations of Medical Sciences (CIOMS)
Download or read book International Ethical Guidelines for Health-Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.
Book Synopsis Clinical Trials in Neurology by : Bernard Ravina
Download or read book Clinical Trials in Neurology written by Bernard Ravina and published by Cambridge University Press. This book was released on 2012-04-12 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases. It introduces the reader to the key concepts underpinning trials in the neurosciences. This volume tackles the challenges of developing therapies for neurologic disorders from measurement of agents in the nervous system to the progression of clinical signs and symptoms through illustrating specific study designs and their applications to different therapeutic areas. Clinical Trials in Neurology covers key issues in Phase I, II and III clinical trials, as well as post-marketing safety surveillance. Topics addressed include regulatory and implementation issues, outcome measures and common problems in drug development. Written by a multidisciplinary team, this comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry.
