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Author : Mukesh Nandave
Publisher : Springer Nature
Page : 478 pages
File Size : 53,6 Mb
Release : 2024-06-17
Category : Electronic
ISBN : 9789819989492
Author : Himanshu Baweja
Publisher : Jaypee Brothers,Medical Publishers Pvt. Limited
Page : 256 pages
File Size : 44,6 Mb
Release : 2018-04-30
Category : Medical
ISBN : 9352704967
Author : Mukesh Nandave,Anoop Kumar
Publisher : Springer
Page : 0 pages
File Size : 45,6 Mb
Release : 2024-01-20
Category : Medical
ISBN : 9819989485
The book explores the field of pharmacovigilance, its historical context, along with its critical role in ensuring the safety of medications across the world. From its foundational principles to cutting-edge advancements and future challenges, this book provides a thorough understanding of the field's intricacies. The book begins by establishing the fundamentals of pharmacovigilance, emphasizing its significance in monitoring, detecting, assessing, and preventing adverse drug reactions (ADRs) that occur during the use of medications. Delving into the history of pharmacovigilance and regulatory actions, the book traces the evolution of the field, highlighting significant milestones and the establishment of regulatory frameworks that govern medication safety. It explores the pivotal role of regulatory authorities in developing guidelines, regulations, and policies to safeguard public health. A significant aspect covered in the book is the processing of ADRs, providing insights into the steps involved in handling and evaluating ADR reports. The book also addresses specialized areas within pharmacovigilance, including vaccine safety surveillance, herbovigilance (monitoring the safety of herbal medicines), materiovigilance (monitoring the safety of medical devices), and hemovigilance (ensuring the safety of blood products). Additionally, the book explores the role of pharmacogenetics in pharmacovigilance, highlighting how genetic factors influence individual responses to medications and how this knowledge can be integrated into safety monitoring and risk assessment. This book also covers databases used in pharmacovigilance across the globe, aggregate reporting and pharmacovigilance systems in EU and non-EU countries, and the role of artificial intelligence. Finally, it emphasizes the need for continuous improvement, vigilance, and proactive measures to adapt to the changing healthcare landscape and address emerging safety concerns. The book serves as a comprehensive guide for healthcare professionals, researchers, regulators, and policymakers involved in pharmacovigilance.
Author : Patrick Waller,Mira Harrison-Woolrych
Publisher : John Wiley & Sons
Page : 194 pages
File Size : 55,8 Mb
Release : 2017-05-01
Category : Medical
ISBN : 9781119289746
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 : Charmy S. Kothari,Manan Shah,Rajvi Manthan Patel
Publisher : BoD – Books on Demand
Page : 90 pages
File Size : 48,7 Mb
Release : 2019-03-20
Category : Medical
ISBN : 9781789857597
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.
Author : LISBETH. TOFTE HEMMINGSEN
Publisher : Unknown
Page : 128 pages
File Size : 45,8 Mb
Release : 2018
Category : Electronic
ISBN : 1912055252
Author : Saugata Ghosh
Publisher : Unknown
Page : 0 pages
File Size : 54,7 Mb
Release : 2023-01-10
Category : Electronic
ISBN : 9798889091080
The book "Fundamentals of Pharmacovigilance" provides a thorough overview of many facets of pharmacovigilance, including the necessity of ADR reporting methods, data mining, postmarketing surveillance, and laws in various countries, among other things. Modern medications can not only prevent and treat diseases, but they can also cause negative side effects (ADRs). Adverse drug responses (ADRs) are classified and their causes, mechanisms, and interactions are thoroughly addressed. This book aims to effectively compile all the theoretical components of pharmacovigilance. This book's first chapter explains the fundamental terms linked to pharmacovigilance. The discussion of historical perspectives, needs and aims, and modern pharmacovigilance methodologies continues in further chapters. Healthcare professionals, postgraduate students, business executives, and individuals working in clinical research in academia and the pharmaceutical industry would all benefit from this book.
Author : I. Ralph Edwards,Marie Lindquist
Publisher : Springer
Page : 205 pages
File Size : 53,5 Mb
Release : 2016-10-27
Category : Medical
ISBN : 9783319404004
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 : Dr. Pradeep K. Agarwal
Publisher : Lulu.com
Page : 144 pages
File Size : 52,8 Mb
Release : 2024-06-17
Category : Electronic
ISBN : 9781304172990
Author : Patrick Waller
Publisher : Wiley-Blackwell
Page : 120 pages
File Size : 53,8 Mb
Release : 2009-11-09
Category : Medical
ISBN : 1405194715
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.
Author : Amrita Akhouri
Publisher : CreateSpace
Page : 182 pages
File Size : 48,6 Mb
Release : 2015-02-04
Category : Electronic
ISBN : 1507894457
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.
Author : Barton Cobert
Publisher : Jones & Bartlett Publishers
Page : 433 pages
File Size : 44,5 Mb
Release : 2011-04
Category : Medical
ISBN : 9780763791599
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 : Cobert Barton,Gregory William,Thomas Jean-loup
Publisher : World Scientific
Page : 524 pages
File Size : 43,7 Mb
Release : 2019-04-10
Category : Medical
ISBN : 9789813279162
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.
Author : Elizabeth B. Andrews,Nicholas Moore
Publisher : John Wiley & Sons
Page : 872 pages
File Size : 51,6 Mb
Release : 2014-03-24
Category : Medical
ISBN : 9781118820148
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 : Thao Doan,Cheryl Renz,Fabio Lievano,Mondira Bhattacharya,Linda Scarazzini
Publisher : Elsevier Health Sciences
Page : 228 pages
File Size : 43,6 Mb
Release : 2018-07-31
Category : Medical
ISBN : 9780323581172
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.
