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Author: Elizabeth B. Andrews Publisher: John Wiley & Sons ISBN: 1118820142 Category : Medical Languages : en Pages : 878
Book Description
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: Elizabeth B. Andrews Publisher: John Wiley & Sons ISBN: 1118820142 Category : Medical Languages : en Pages : 878
Book Description
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: Ronald D. Mann Publisher: John Wiley & Sons ISBN: 0470852976 Category : Medical Languages : en Pages : 587
Book Description
Interest in the field of pharmacovigilance has grown rapidly inrecent years with the possible toxicity of a drug becoming as mucha focus of clinical trials as its benefits. This key text is adefinitive resource for professionals working withinpharmacovigilance. Written by leading professionals in the field,its clear structure, covers all the important aspects of thesubject including:- * Legal aspects * Drug regulatory requirements * Methods of signal generation * Reporting schemes * Pharmacovigilance in selected system-organ classes * Future directions This comprehensive book should be in all pharmacovigilancedepartments, regional pharmacovigilance centres and regulatory authorities. It is anunparalleled source of information and reference for all researchers inpharmacovigilance, pharmaceutical practice and medicine.
Author: Agency for Healthcare Research and Quality/AHRQ Publisher: Government Printing Office ISBN: 1587634333 Category : Medical Languages : en Pages : 385
Book Description
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.
Author: Barton Cobert Publisher: Jones & Bartlett Publishers ISBN: 0763791598 Category : Medical Languages : en Pages : 433
Book Description
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, pharmacology, 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.
Author: Patrick Waller Publisher: John Wiley & Sons ISBN: 1119289785 Category : Medical Languages : en Pages : 192
Book Description
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.
Author: Thao Doan Publisher: Elsevier Health Sciences ISBN: 032358117X Category : Medical Languages : en Pages : 229
Book Description
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. - Covers the evolving regulatory landscape, as well as current and future use of digital technologies. - Uses case studies to ensure content is relevant to everyday practice. - Discusses behavioral science and patient perspectives, risk communication, and new frontiers in pharmacovigilance. - Consolidates today's available information on this timely topic into one convenient resource.
Author: I. Ralph Edwards Publisher: Springer ISBN: 3319404008 Category : Medical Languages : en Pages : 227
Book Description
Written by experienced authors, this book offers expert personal views on what the current problems in pharmacovigilance are and how they should be solved. This book stems from thoughts and ideas discussed in a series of meetings of the International Society of Pharmacovigilance (ISoP), where concerns were raised that the current pharmacovigilance system is not delivering optimally to improve therapeutics in clinical practice. Pharmacovigilance of the future must be an active and integral part of health care delivery, and focus more on science and practices that support health professionals and patients in day-to-day care situations. To achieve this, a dynamic and sustainable development of vigilance must take precedence over the current excessive preoccupations with data processing and regulations; all aspects of medicines use and their effects need to be considered; and all stakeholders must be involved and engaged in an open and constructive debate. The work is essential reading for anyone who has an interest in safer use of medicines. It is intended to be equally challenging and rewarding, and sets out to stimulate a continuous debate on how pharmacovigilance can better meet the needs of health professionals and patients to achieve the aim of wise therapeutic decision making.
Author: Elizabeth B. Andrews
Author: Elizabeth B. Andrews
Author: Ronald D. Mann
Author: Agency for Healthcare Research and Quality/AHRQ
Author: Barton Cobert
Author: Patrick Waller
Author: Thao Doan
Author: Deepa Arora
Author: I. Ralph Edwards
Author: Michel Auriche
Author: Organización Mundial de la Salud