Pharmacovigilance English Edition

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An Introduction to Pharmacovigilance

Author : Patrick Waller
Publisher : John Wiley & Sons
ISBN 13 : 1119289742
Total Pages : 194 pages
Book Rating : 4.1/5 (192 download)

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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.

Pharmacovigilance: A Practical Approach

Author : Thao Doan
Publisher : Elsevier Health Sciences
ISBN 13 : 032358117X
Total Pages : 229 pages
Book Rating : 4.3/5 (235 download)

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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 229 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. - 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.

Mann's Pharmacovigilance

Author : Elizabeth B. Andrews
Publisher : John Wiley & Sons
ISBN 13 : 1118820142
Total Pages : 878 pages
Book Rating : 4.1/5 (188 download)

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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 878 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.

Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)

Author : Barton Cobert
Publisher : World Scientific
ISBN 13 : 9813279168
Total Pages : 525 pages
Book Rating : 4.8/5 (132 download)

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Book Synopsis Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) by : Barton Cobert

Download or read book Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) written by Barton Cobert and published by World Scientific. This book was released on 2019-04-09 with total page 525 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.Related Link(s)

Cobert's Manual of Drug Safety and Pharmacovigilance

Author : Barton Cobert
Publisher : Jones & Bartlett Publishers
ISBN 13 : 0763791601
Total Pages : 431 pages
Book Rating : 4.7/5 (637 download)

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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.

Textbook of Pharmacovigilance

Author : SK Gupta
Publisher : Jaypee Brothers Medical Publishers
ISBN 13 : 9789352707034
Total Pages : 638 pages
Book Rating : 4.7/5 (7 download)

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Book Synopsis Textbook of Pharmacovigilance by : SK Gupta

Download or read book Textbook of Pharmacovigilance written by SK Gupta and published by Jaypee Brothers Medical Publishers. This book was released on 2018-12-24 with total page 638 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pharmacovigilance Medical Writing

Author : Justina Orleans-Lindsay
Publisher : John Wiley & Sons
ISBN 13 : 1118302060
Total Pages : 182 pages
Book Rating : 4.1/5 (183 download)

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Book Synopsis Pharmacovigilance Medical Writing by : Justina Orleans-Lindsay

Download or read book Pharmacovigilance Medical Writing written by Justina Orleans-Lindsay and published by John Wiley & Sons. This book was released on 2012-06-22 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pharmacovigilance

Author : Ronald D. Mann
Publisher : John Wiley & Sons
ISBN 13 : 0470059222
Total Pages : 709 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis Pharmacovigilance by : Ronald D. Mann

Download or read book Pharmacovigilance written by Ronald D. Mann and published by John Wiley & Sons. This book was released on 2007-02-06 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by an international team of outstanding editors andcontributors, Pharmacovigilance, 2ndEdition is the definitive text on this importantsubject. The new edition has been completely revised andupdated to include the latest theoretical and practical aspects ofpharmacovigilance including legal issues, drug regulatoryrequirements, methods of signal generation, reporting schemes andpharmacovigilance in selected system-organ classes. . The editors and contributors are of excellent standing withinthe pharmacovigilance community The text provides exemplary coverage of all the relevantissues The definitive book on the subject

Dictionary of Pharmacovigilance

Author : Amer Alghabban
Publisher :
ISBN 13 :
Total Pages : 552 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Dictionary of Pharmacovigilance by : Amer Alghabban

Download or read book Dictionary of Pharmacovigilance written by Amer Alghabban and published by . This book was released on 2004 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pharmacoepidemiology and Pharmacovigilance

Author : Sabrina Nour
Publisher : Academic Press
ISBN 13 : 012816381X
Total Pages : 240 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Pharmacoepidemiology and Pharmacovigilance by : Sabrina Nour

Download or read book Pharmacoepidemiology and Pharmacovigilance written by Sabrina Nour and published by Academic Press. This book was released on 2018-10-17 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

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

Author : Michael J. Klepper
Publisher : Jones & Bartlett Publishers
ISBN 13 : 1449671551
Total Pages : 332 pages
Book Rating : 4.4/5 (496 download)

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Book Synopsis Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk by : Michael J. Klepper

Download or read book Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk written by Michael J. Klepper and published by Jones & Bartlett Publishers. This book was released on 2010-09-15 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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)

The Textbook of Pharmaceutical Medicine

Author : John P. Griffin
Publisher : John Wiley & Sons
ISBN 13 : 047098726X
Total Pages : 883 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis The Textbook of Pharmaceutical Medicine by : John P. Griffin

Download or read book The Textbook of Pharmaceutical Medicine written by John P. Griffin and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 883 pages. Available in PDF, EPUB and Kindle. Book excerpt: New edition of succesful standard reference book for thepharmaceutical industry and pharmaceutical physicians! The Textbook of Pharmaceutical Medicine is the coursebookfor the Diploma in Pharmaceutical Medicine, and is used as astandard reference throughout the pharmaceutical industry. The newedition includes greater coverage of good clinical practice, acompletely revised statistics chapter, and more on safety. Coversthe course information for the Diploma in PharmaceuticalMedicine Fully updated, with new authors Greater coverage of good clinical practice and safety New chapters on regulation of medical devices in Europe andregulation of therapeutic products in Australia

Drug Safety in Developing Countries

Author : Yaser Mohammed Al-Worafi
Publisher : Academic Press
ISBN 13 : 0128204125
Total Pages : 656 pages
Book Rating : 4.1/5 (282 download)

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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

The Detection of New Adverse Drug Reactions

Author : M. D. B. Stephens
Publisher : Springer
ISBN 13 : 1349072508
Total Pages : 269 pages
Book Rating : 4.3/5 (49 download)

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Book Synopsis The Detection of New Adverse Drug Reactions by : M. D. B. Stephens

Download or read book The Detection of New Adverse Drug Reactions written by M. D. B. Stephens and published by Springer. This book was released on 1985-06-18 with total page 269 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Veterinary Pharmacovigilance

Author : Kevin Woodward
Publisher : John Wiley & Sons
ISBN 13 : 9781444322941
Total Pages : 776 pages
Book Rating : 4.3/5 (229 download)

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Book Synopsis Veterinary Pharmacovigilance by : Kevin Woodward

Download or read book Veterinary Pharmacovigilance written by Kevin Woodward and published by John Wiley & Sons. This book was released on 2009-11-24 with total page 776 pages. Available in PDF, EPUB and Kindle. Book excerpt: Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products is an in-depth examination of veterinary pharmacovigilance, looking at the scientific methodologies involved, the role of regulatory agencies and legislation, and the underpinning science. Edited by a renowned expert with over 20 years of experience in the field, it draws together the expertise of authors from around the world.

Stephens' Detection and Evaluation of Adverse Drug Reactions

Author : John Talbot
Publisher : John Wiley & Sons
ISBN 13 : 1119952107
Total Pages : 751 pages
Book Rating : 4.1/5 (199 download)

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Book Synopsis Stephens' Detection and Evaluation of Adverse Drug Reactions by : John Talbot

Download or read book Stephens' Detection and Evaluation of Adverse Drug Reactions written by John Talbot and published by John Wiley & Sons. This book was released on 2011-10-28 with total page 751 pages. Available in PDF, EPUB and Kindle. Book excerpt: The detection and evaluation of adverse drug reactions is crucial for understanding the safety of medicines and for preventing harm in patients. Not only is it necessary to detect new adverse drug reactions, but the principles and practice of pharmacovigilance apply to the surveillance of a wide range of medicinal products. Stephens' Detection and Evaluation of Adverse Drug Reactions provides a comprehensive review of all aspects of adverse drug reactions throughout the life cycle of a medicine, from toxicology and clinical trials through to pharmacovigilance, risk management, and legal and regulatory requirements. It also covers the safety of biotherapeutics and vaccines and includes new chapters on pharmacogenetics, proactive risk management, societal considerations, and the safety of drugs used in oncology and herbal medicines. This sixth edition of the classic text on drug safety is an authoritative reference text for all those who work in pharmacovigilance or have an interest in adverse drug reactions, whether in regulatory authorities, pharmaceutical companies, or academia. Praise for previous editions "This book presents a comprehensive and wide-ranging overview of the science of pharmacovigilance. For those entering or already experienced in the pharmaceutical sciences, this is an essential work.” - from a review in E-STREAMS "...a key text in the area of pharmacovigilance...extensively referenced and well-written...a valuable resource..." - from a review in The Pharmaceutical Journal

Essentials of Pharmacovigilance

Author : Himanshu Baweja
Publisher : Jaypee Brothers Medical Publishers Pvt. Limited
ISBN 13 : 9789352704965
Total Pages : 0 pages
Book Rating : 4.7/5 (49 download)

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Book Synopsis Essentials of Pharmacovigilance by : Himanshu Baweja

Download or read book Essentials of Pharmacovigilance written by Himanshu Baweja and published by Jaypee Brothers Medical Publishers Pvt. Limited. This book was released on 2018-04-30 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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