An Introduction to Pharmacovigilance
An Introduction to Pharmacovigilance

Author: Patrick Waller

Publisher: John Wiley & Sons

Published: 2017-05-01

Total Pages: 194

ISBN-13: 1119289742

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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.

An Introduction to Pharmacovigilance
An Introduction to Pharmacovigilance

Author: Patrick Waller

Publisher: Wiley-Blackwell

Published: 2009-11-09

Total Pages: 120

ISBN-13: 9781405194716

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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.

Mann's Pharmacovigilance
Mann's Pharmacovigilance

Author: Elizabeth B. Andrews

Publisher: John Wiley & Sons

Published: 2014-03-24

Total Pages: 878

ISBN-13: 1118820142

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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.

Pharmacovigilance: A Practical Approach
Pharmacovigilance: A Practical Approach

Author: Thao Doan

Publisher: Elsevier Health Sciences

Published: 2018-07-31

Total Pages: 228

ISBN-13: 032358117X

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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.

An Introduction To Pharmacovigilance
An Introduction To Pharmacovigilance

Author: Dr. Krishnaraju Venkatesan

Publisher: AG PUBLISHING HOUSE (AGPH Books)

Published: 2022-12-13

Total Pages: 198

ISBN-13: 8196024320

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The pharmaceutical science concerned with the gathering, identification, evaluation, monitoring, and prevention of adverse effects with pharmaceutical goods is known as pharmacovigilance (PV, or PhV), sometimes known as drug safety. Thus, adverse drug reactions (ADRs) are a major focus of pharmacovigilance. An ADR is any response to a medicine that is unpleasant and undesired, including ineffectiveness. The stipulation that such a definition only applies to the dosages ordinarily used for the prevention, diagnosis, or treatment of illness, or the alteration of physiological disorder function, was eliminated with the latest change to the relevant law. Medication errors such as overdosing, misusing, or abusing a medication, or being exposed to a drug while pregnant or nursing are also of interest, even in the absence of an adverse event, since they may lead to adverse drug reactions. An Introduction to Pharmacovigilance book relies heavily on the information gathered from patients and healthcare professionals via pharmacovigilance agreements and other sources including the medical literature. Adverse event data obtained by the licence holder, often a pharmaceutical company, must be reported to the local drug regulatory authorities to sell or test the pharmaceutical product in most countries. vi Ultimately, pharmacovigilance focuses on recognizing risks connected with pharmaceutical goods and reducing the risk of adverse events occurring in patients. To determine whether or not they are following all applicable laws, regulations, and guidelines throughout the globe, businesses should undertake a thorough audit of medication safety and pharmacovigilance practices

Dictionary of Pharmacovigilance
Dictionary of Pharmacovigilance

Author: Amer Alghabban

Publisher:

Published: 2004

Total Pages: 552

ISBN-13:

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Pharmacovigilance is, in essence, the process of monitoring the everyday use of medicines to identify previously unrecognised adverse drug reactions, thereby assessing their risk/benefit balance in order to determine what action, if any, is necessary to improve their safe use. As a discipline, pharmacovigilance impacts on many specialist areas such as pharmacoepidemiology, medical practice, public health, but is most intimately linked to clinical research, development and drug licensing. The discipline along with its operational and legal facets, for both regulatory authorities and pharmaceutical industry, envelop colossal terminology that has precise legal and scientific significance. Such terminology may vary from country to country, or more confusingly, different countries may use identical or similar abbreviations, terms or phrases to mean different entities.The Dictionary of Pharmacovigilance contains a comprehensive list of abbreviations, terms and phrases (in English) giving definitions of commonly (and rarely) encountered pharmacovigilance terms. Examples include: Absolute Risk Increase (ARI), Bayesian Confidence Propagation Neural Network (BCPNN), Confounding Factor, Case narrative, Causality Assessment, Company Core Safety Information (CCSI), Data mining, 15-day report, Rechallenge, Directive 2001/83/EC, EU Birth Date, Expert report, FDA Form 1639, Historical control, Number Needed to Harm, Toxikinetics, Post-Marketing Surveillance, Qualified Person, Source Data Verification (SDV), Spontaneous Reporting, Vaccine Adverse Event Reporting System (VAERS), Warning Letter, Product Withdrawal.

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk
Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk

Author: Michael J. Klepper

Publisher: Jones & Bartlett Publishers

Published: 2010-09-15

Total Pages: 332

ISBN-13: 1449671551

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Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)

Drug Safety in Developing Countries
Drug Safety in Developing Countries

Author: Yaser Mohammed Al-Worafi

Publisher: Academic Press

Published: 2020-06-03

Total Pages: 656

ISBN-13: 0128204125

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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

Pharmacoepidemiology and Pharmacovigilance
Pharmacoepidemiology and Pharmacovigilance

Author: Sabrina Nour

Publisher: Academic Press

Published: 2018-10-17

Total Pages: 240

ISBN-13: 012816381X

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Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologic research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate the passive and active surveillance of adverse drug reactions in clinical situations, covering important pharmacoepidemiologic concepts like health risk management and safety. The book helps pharmaceutical industry groups engaged in drug safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for all patient populations. Describes the main prevention tools for the passive and active surveillance of adverse effects associated with drugs Provides examples of diseases in various contexts related to clinical studies and the analysis of adverse drug reactions Offers case studies that illustrate real-life clinical situations Discusses important concepts related to pharmacoepidemiology and pharmacovigilance

Evidence-Based Pharmacovigilance
Evidence-Based Pharmacovigilance

Author: Andrew Bate

Publisher: Humana

Published: 2018-10-26

Total Pages: 0

ISBN-13: 9781493988167

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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.