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Pharmacovigilance A Practical Approach
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Book Synopsis Pharmacovigilance: A Practical Approach by : Thao Doan
Download or read book Pharmacovigilance: A Practical Approach written by Thao Doan and published by Elsevier Health Sciences. This book was released on 2018-07-31 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.
Book Synopsis Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) by : Cobert Barton
Download or read book Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) written by Cobert Barton and published by World Scientific. This book was released on 2019-04-10 with total page 524 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies — both in the United States and around the world — and provides critical information about what to do when confronted with a drug safety problem.
Book Synopsis Cobert's Manual of Drug Safety and Pharmacovigilance by : Barton Cobert
Download or read book Cobert's Manual of Drug Safety and Pharmacovigilance written by Barton Cobert and published by Jones & Bartlett Publishers. This book was released on 2011-04 with total page 431 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated, the Manual of Drug Safety and Pharmacovigilance, Second Edition is a how-to manual for those working in the fields of drug safety, clinical research, pharmacuetucal, regulatory affairs, government and legal professions. This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance) and side effects, as well as providing essential information on drug safety and regulations, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions. The Manual of Drug Safety and Pharmacovigilance, Second Edition teaches the ins and outs of drug safety in the industry, hospitals, FDA, and other health agencies both in the US and around the world, and presents critical information about what is done when confronted with a drug safety problem.
Book Synopsis Clinical Pharmacy Education, Practice and Research by : Dixon Thomas
Download or read book Clinical Pharmacy Education, Practice and Research written by Dixon Thomas and published by Elsevier. This book was released on 2018-11-23 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a basis to standardize and coordinate learning to practice, explaining basics and using self-learning strategies through online resources or other advanced texts. With an educational approach, it guides pharmacy students and pharmacists to learn quickly and apply. Clinical Pharmacy Education, Practice and Research provides an essential foundation for pharmacy students and pharmacists globally. Covers the core information needed for pharmacy practice courses Includes multiple case studies and practical situations with 70% focused on practical clinical pharmacology knowledge Designed for educational settings, but also useful as a refresher for advanced students and researchers
Book Synopsis A Practical Approach to Pharmaceutical Policy by : Andreas Seiter
Download or read book A Practical Approach to Pharmaceutical Policy written by Andreas Seiter and published by World Bank Publications. This book was released on 2010-06-17 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers policy makers a hands-on approach, tested in the World Bank’s field work in many countries, for developing policies that improve access to safe, effective medicines in health systems of low- and middle-income economies.
Book Synopsis An Introduction to Pharmacovigilance by : Patrick Waller
Download or read book An Introduction to Pharmacovigilance written by Patrick Waller and published by John Wiley & Sons. This book was released on 2017-05-01 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance. Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.
Book Synopsis Drug Safety in Developing Countries by : Yaser Mohammed Al-Worafi
Download or read book Drug Safety in Developing Countries written by Yaser Mohammed Al-Worafi and published by Academic Press. This book was released on 2020-06-03 with total page 656 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues Describes current achievements of drug safety practice in developing countries Addresses the challenges of drug safety in developing countries Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety
Book Synopsis Practical Drug Safety from A to Z by : Barton Cobert
Download or read book Practical Drug Safety from A to Z written by Barton Cobert and published by Jones & Bartlett Publishers. This book was released on 2009-10-06 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Practical Drug Safety from A to Z is an alphabetical guide to drug safety monitoring (pharmacovigilance), covering literally, the "A to Z" of maintaining drug safety. Written by experts in the field, this book is a perfect to companion to the Manual of Drug Safety and Pharmacovigilance and an essential reference for pharmacists, pharmacologists, hospital administrators, medical liability lawyers, and others.
Book Synopsis Therapeutic Risk Management of Medicines by : Stephen J. Mayall
Download or read book Therapeutic Risk Management of Medicines written by Stephen J. Mayall and published by Elsevier. This book was released on 2014-04-16 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders. A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US. This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts. An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicines A number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan) A comprehensive guide for performing risk management more effectively throughout a product’s life-cycle
Book Synopsis Mind Maps of Pharmacovigilance Basics by : Amrita Akhouri
Download or read book Mind Maps of Pharmacovigilance Basics written by Amrita Akhouri and published by CreateSpace. This book was released on 2015-02-04 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book would be useful to anyone who wishes to enrich his/her knowledge on the fundamentals of pharmacovigilance. I ardently hope that this book would prove to be a true help to all those who are seeking to learn and grow in the field of pharmacovigilance. Some of the readers might wonder what prompted me to write this book when there are several books already available on Pharmacovigilance basics. In my opinion, there is a need for an organized study material which talks about the subject at the foundation level and presents the content in a form which is easy for the readers to understand/revise quickly. Hence, this book offers the readers a unique organized study material which comprises of mind maps, flow charts, short notes, text explanation and glossary thus, presenting the intricate concepts of the subject in a very simple manner. Over and above the core subject, this book also throws some light on careers in the field of pharmacovigilance which will be very helpful for the candidates preparing for job interviews in this field.
Book Synopsis Pharmacovigilance by : Charmy S. Kothari
Download or read book Pharmacovigilance written by Charmy S. Kothari and published by BoD – Books on Demand. This book was released on 2019-03-20 with total page 90 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book "Pharmacovigilance" describes the pathway to understand that pharmacovigilance plays a specialized and pivotal role in ensuring ongoing safety of medicinal products. Written in plain English, the book is concise, jargon-free, and facilitates an understanding of fundamentals of pharmacovigilance and explores regulatory aspects involved in pharmacovigilance.
Book Synopsis A Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines by : World Health Organization
Download or read book A Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines written by World Health Organization and published by World Health Organization. This book was released on 2009 with total page 146 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programmes. A number of WHO publications are available that provide a background to pharmacovigilance and, as far as possible, that material will not be repeated here."--Publisher's description.
Book Synopsis Principles and Practice of Pharmacovigilance and Drug Safety by : Jimmy Jose
Download or read book Principles and Practice of Pharmacovigilance and Drug Safety written by Jimmy Jose and published by Springer. This book was released on 2024-04-05 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The science of drug safety and pharmacovigilance has rapidly evolved in the 21st century. The knowledge and principles it contains are of increasing importance in clinical and practice settings. The aim of this book is to deal with the gap in knowledge about pharmacovigilance and drug safety, including the application of pharmacovigilance knowledge to individual patient cases in clinical practice. A holistic approach is taken with each chapter written from the perspective of a practitioner, industry personnel, researcher, or regulator, creating a synergy between drug safety, pharmacovigilance, and clinical practice. Chapters offer key material on adverse drug reactions, medication errors, prescribing safety, pharmacovigilance as well as data sources used in drug safety and pharmacovigilance. Each chapter is structured as a self-contained learning resource, with learning objectives, and worked cases. The book is suitable for undergraduate healthcare professions, postgraduate students, researchers, clinical practitioners – including those with prescribing responsibilities. It will also be useful for professionals moving from a clinical practice role to a specialist pharmacovigilance role. For those already in a pharmacovigilance role, the book offers insight into the theory and practice of drug safety and pharmacovigilance in clinical settings.
Author :Council for International Organizations of Medical Sciences (CIOMS) Publisher :Cioms ISBN 13 :9789290360827 Total Pages :0 pages Book Rating :4.3/5 (68 download)
Book Synopsis Practical Aspects of Signal Detection in Pharmacovigilance by : Council for International Organizations of Medical Sciences (CIOMS)
Download or read book Practical Aspects of Signal Detection in Pharmacovigilance written by Council for International Organizations of Medical Sciences (CIOMS) and published by Cioms. This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.
Book Synopsis Mann's Pharmacovigilance by : Elizabeth B. Andrews
Download or read book Mann's Pharmacovigilance written by Elizabeth B. Andrews and published by John Wiley & Sons. This book was released on 2014-03-24 with total page 872 pages. Available in PDF, EPUB and Kindle. Book excerpt: Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann’s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.
Author :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :396 pages Book Rating :4.5/5 (876 download)
Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Book Synopsis To Err Is Human by : Institute of Medicine
Download or read book To Err Is Human written by Institute of Medicine and published by National Academies Press. This book was released on 2000-03-01 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That's more than die from motor vehicle accidents, breast cancer, or AIDSâ€"three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems. To Err Is Human breaks the silence that has surrounded medical errors and their consequenceâ€"but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agendaâ€"with state and local implicationsâ€"for reducing medical errors and improving patient safety through the design of a safer health system. This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients' expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes. Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errorsâ€"which begs the question, "How can we learn from our mistakes?" Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care. To Err Is Human asserts that the problem is not bad people in health careâ€"it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocatesâ€"as well as patients themselves. First in a series of publications from the Quality of Health Care in America, a project initiated by the Institute of Medicine
