Essentials Of Pharmacovigilance
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| Author | : Himanshu Baweja |
| Publisher | : Jaypee Brothers Medical Publishers Pvt. Limited |
| Total Pages | : 0 |
| Release | : 2018-04-30 |
| Genre | : Medical |
| ISBN | : 9789352704965 |
Pharmacovigilance: A Complete Study about the Knowledge of Adverse Drug Reaction History of Pharmacovigilance Aim and Importance of Pharmacovigilance Role of Healthcare Professionals in Pharmacovigilance Importance of Pharmacovigilance in Special Groups such as Infants, Elderly and Pregnant Women Legal Aspects of Pharmacovigilance Pharmacovigilance Programme of India Practical Aspects of Pharmacovigilance Practices at Corporate Hospital Medication Errors, Its Practical Analysis and Resolution Recording and Reporting of Adverse Drug Reactions Periodic Safety Update Report Causality Assessment of Drugs and Medical Devices: Logic and Method Cure to Prescription: E-Prescription Drug-Drug Interactions in Tertiary Care Hospital Therapeutic Drug Monitoring Postmarket Surveillance Program Concepts, Goals and Practices Hemovigilance Index
| Author | : Patrick Waller |
| Publisher | : John Wiley & Sons |
| Total Pages | : 194 |
| Release | : 2017-05-01 |
| Genre | : Medical |
| ISBN | : 1119289742 |
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 |
| Total Pages | : 229 |
| Release | : 2018-07-31 |
| Genre | : Medical |
| ISBN | : 032358117X |
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 | : Elizabeth B. Andrews |
| Publisher | : John Wiley & Sons |
| Total Pages | : 878 |
| Release | : 2014-03-24 |
| Genre | : Medical |
| ISBN | : 1118820142 |
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 | : Barton Cobert |
| Publisher | : Jones & Bartlett Publishers |
| Total Pages | : 431 |
| Release | : 2011-04 |
| Genre | : Medical |
| ISBN | : 0763791601 |
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.
| Author | : SK Gupta |
| Publisher | : Jaypee Brothers Medical Publishers |
| Total Pages | : 638 |
| Release | : 2018-12-24 |
| Genre | : Medical |
| ISBN | : 9789352707034 |
| Author | : Yaser Mohammed Al-Worafi |
| Publisher | : Academic Press |
| Total Pages | : 656 |
| Release | : 2020-06-03 |
| Genre | : Medical |
| ISBN | : 0128204125 |
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
| Author | : Justina Orleans-Lindsay |
| Publisher | : John Wiley & Sons |
| Total Pages | : 182 |
| Release | : 2012-06-22 |
| Genre | : Medical |
| ISBN | : 1118302060 |
Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e.g. scheduling, source data, department/functions involved in document preparation/review, appropriate timelines and planning activities), ending with a generic model document compliant with the current guidelines, which can be modified to meet specific company and product requirements.
| Author | : Andrew Bate |
| Publisher | : Humana |
| Total Pages | : 0 |
| Release | : 2018-10-26 |
| Genre | : Medical |
| ISBN | : 9781493988167 |
This book examines insights into the latest thinking and core concepts in areas of key methodological endeavor in Pharmacovigilance (PV), which strives to ever more effectively protect patients from harm caused by the medicines they need. Each book chapter tends to have a clear quantitative or clinical slant and an aim to provide an overview of methodological insights within a specific topic, while also providing a perspective on how the area is anticipated to develop in the future. Quantitative chapters focus more on statistical and epidemiological strategies and the thinking that underpins core developments in Pharmacovigilance, whereas clinical chapters focus on clinical methods for detecting hypotheses for and determining side effects of medicinal products as well as misdiagnosis pitfalls. Examples of areas of importance include signal detection, risk management, and risk benefit assessment. Vital and authoritative, Evidence-Based Pharmacovigilance: Clinical and Quantitative Aspects aims to provide readers with a sense of the advances that have occurred in pharmacovigilance methods and approaches, as well as inspiration and motivation to advance the field of pharmacovigilance with a strong sense that there is much more work to be done in ensuring the safe use of medications by patients.
| Author | : Barton Cobert |
| Publisher | : World Scientific |
| Total Pages | : 525 |
| Release | : 2019-04-09 |
| Genre | : Medical |
| ISBN | : 9813279168 |
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.Related Link(s)
