An Introduction To Pharmacovigilance

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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.

An Introduction to Pharmacovigilance

Author : Patrick Waller
Publisher : Wiley-Blackwell
ISBN 13 : 9781405194716
Total Pages : 120 pages
Book Rating : 4.1/5 (947 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 Wiley-Blackwell. This book was released on 2009-11-09 with total page 120 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.

Mann's Pharmacovigilance

Author : Elizabeth B. Andrews
Publisher : John Wiley & Sons
ISBN 13 : 1118820142
Total Pages : 872 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 872 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.

Pharmacovigilance: A Practical Approach

Author : Thao Doan
Publisher : Elsevier Health Sciences
ISBN 13 : 032358117X
Total Pages : 228 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 228 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.

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.

Pharmacoepidemiology and Pharmacovigilance

Author : Sabrina Nour
Publisher : Academic Press
ISBN 13 : 012816381X
Total Pages : 144 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 144 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 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

An Introduction To Pharmacovigilance

Author : Dr. Krishnaraju Venkatesan
Publisher : AG PUBLISHING HOUSE (AGPH Books)
ISBN 13 : 8196024320
Total Pages : 198 pages
Book Rating : 4.1/5 (96 download)

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Book Synopsis An Introduction To Pharmacovigilance by : Dr. Krishnaraju Venkatesan

Download or read book An Introduction To Pharmacovigilance written by Dr. Krishnaraju Venkatesan and published by AG PUBLISHING HOUSE (AGPH Books). This book was released on 2022-12-13 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Mind Maps of Pharmacovigilance Basics

Author : Amrita Akhouri
Publisher : CreateSpace
ISBN 13 : 9781507894453
Total Pages : 182 pages
Book Rating : 4.8/5 (944 download)

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Book Synopsis Mind Maps of Pharmacovigilance Basics by : Amrita Akhouri

Download or read book Mind Maps of Pharmacovigilance Basics written by Amrita Akhouri and published by CreateSpace. This book was released on 2015-02-04 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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

Author : Cobert Barton
Publisher : World Scientific
ISBN 13 : 9813279168
Total Pages : 524 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 : Cobert Barton

Download or read book Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) written by Cobert Barton and published by World Scientific. This book was released on 2019-04-10 with total page 524 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.

Post-Authorization Safety Studies of Medicinal Products

Author : Ayad K. Ali
Publisher : Academic Press
ISBN 13 : 0128092084
Total Pages : 362 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Post-Authorization Safety Studies of Medicinal Products by : Ayad K. Ali

Download or read book Post-Authorization Safety Studies of Medicinal Products written by Ayad K. Ali and published by Academic Press. This book was released on 2018-06-27 with total page 362 pages. Available in PDF, EPUB and Kindle. Book excerpt: Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in the literature by providing a complete look at post-authorization safety studies and important pharmacoepidemiology and pharmacovigilance aspects. It covers various types and limitations of active surveillance programs, including the use of large databases and disparate data sources for rapid signal detection, as well as novel and advanced design and analysis approaches for causal interference from observational data. This book serves as an important reference for pharmacovigilance scientists and pharmacoepidemiologists who are searching for the appropriate study design to answer safety research questions. Readers will be able to effectively and efficiently design and interpret findings from post-authorization safety studies with the goal of improving the benefit-risk balance of a drug in order to optimize patient safety. Discusses all types of observational studies in post-marketing drug safety assessment, from spontaneous reporting systems, to pragmatic trials, with examples from real-world settings Presents various types of post-authorization safety studies Offers solutions to the common challenges in the design and conduct of these studies Highlights active surveillance programs, including common data models for rapid signal detection of drug safety issues

Stephens' Detection of New Adverse Drug Reactions

Author : John Talbot
Publisher : John Wiley & Sons
ISBN 13 : 0470092653
Total Pages : 762 pages
Book Rating : 4.4/5 (7 download)

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

Download or read book Stephens' Detection of New Adverse Drug Reactions written by John Talbot and published by John Wiley & Sons. This book was released on 2004-11-19 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: A key text for all those involved in pharmacovigilance. Detection of new adverse drug reactions is fundamental to the protection of patients from harm that may occur as a result of medication. This book explores the methods used to investigate new adverse drug reactions, discussing all elements from the scientific background and animal toxicology through to worldwide regulatory and ethical issues. Stephens' Detection of New Adverse Drug Reactions provides comprehensive and up-to-date coverage of material fundamentally important to all those active in the field, whether they work in the pharmaceutical industry, drug regulatory authorities or in academia. The fifth edition of this classic reference work includes new chapters on: vaccine safety surveillance managing drug safety issues with marketed products operational aspects of drug safety function safety of biotechnology products future of pharmacovigilance Reviews of previous editions: "This book surpasses all its educational aims. Not only is the subject matter covered comprehensively but the material is presented in a very user-friendly manner. The editors have succeeded in producing a highly-specific, definitive reference book which doubles as a most enjoyable read." —Commended by the 1999 BMA Medical Book Competition "For anyone entering the field of adverse reaction monitoring one could not wish for a better primer" —International Journal of Risk and Safety in Medicine

Pharmacovigilance

Author : Ravi N. Humbarwadi
Publisher : CreateSpace
ISBN 13 : 9781497363946
Total Pages : 132 pages
Book Rating : 4.3/5 (639 download)

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Book Synopsis Pharmacovigilance by : Ravi N. Humbarwadi

Download or read book Pharmacovigilance written by Ravi N. Humbarwadi and published by CreateSpace. This book was released on 2014-03-21 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designed for the practice of professional pharmacovigilance. MedDRA, FDA, EMEA, Eudravigilance, Regulatory framework submissions and timelines, GVP - 2012, Narrative Writing - Rules & Format, ARGUS, Signal Detection. Special Features. The Pharmacovigilance Interview: Can help you clear job interviews and start a career or get that better job. An exhaustive yet usable list of IME: Can help a professional differentiate between serious and non-serious cases and improve regulatory submission compliance.

Drug Utilization Research

Author : Monique Elseviers
Publisher : John Wiley & Sons
ISBN 13 : 1118949781
Total Pages : 548 pages
Book Rating : 4.1/5 (189 download)

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Book Synopsis Drug Utilization Research by : Monique Elseviers

Download or read book Drug Utilization Research written by Monique Elseviers and published by John Wiley & Sons. This book was released on 2016-05-31 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Utilization Research (DUR) is an eclectic scientific discipline, integrating descriptive and analytical methods for the quantification, understanding and evaluation of the processes of prescribing, dispensing and consumption of medicines and for the testing of interventions to enhance the quality of these processes. The discipline is closely related and linked mainly to the broader field of pharmacoepidemiology, but also to health outcomes research, pharmacovigilance and health economics. Drug Utilization Research is a unique, practical guide to the assessment and evaluation of prescribing practices and to interventions to improve the use of medicines in populations. Edited by an international expert team from the International Society for Pharmacoepidemiology (ISPE), DUR is the only title to cover both the methodology and applications of drug utilization research and covers areas such as health policy, specific populations, therapeutics and adherence.

Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis

Author : World Health Organization
Publisher :
ISBN 13 : 9789241501583
Total Pages : 0 pages
Book Rating : 4.5/5 (15 download)

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Book Synopsis Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis by : World Health Organization

Download or read book Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis written by World Health Organization and published by . This book was released on 2015-04-20 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This 2011 update of Guidelines for the programmatic management of drug-resistant tuberculosis is intended as a tool for use by public health professionals working in response to the Sixty-second World Health Assembly's resolution on prevention and control of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis. Resolution WHA62.15, adopted in 2009, calls on Member States to develop a comprehensive framework for the management and care of patients with drug-resistant TB. The recommendations contained in these guidelines address the most topical questions concerning the programmatic management of drug-resistant TB: case-finding, multidrug resistance, treatment regimens, monitoring the response to treatment, and selecting models of care. The guidelines primarily target staff and medical practitioners working in TB treatment and control, and partners and organizations providing technical and financial support for care of drug-resistant TB in settings where resources are limited.

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

Clinical Pharmacy Education, Practice and Research

Author : Dixon Thomas
Publisher : Elsevier
ISBN 13 : 0128142774
Total Pages : 540 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Clinical Pharmacy Education, Practice and Research by : Dixon Thomas

Download or read book Clinical Pharmacy Education, Practice and Research written by Dixon Thomas and published by Elsevier. This book was released on 2018-11-23 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a basis to standardize and coordinate learning to practice, explaining basics and using self-learning strategies through online resources or other advanced texts. With an educational approach, it guides pharmacy students and pharmacists to learn quickly and apply. Clinical Pharmacy Education, Practice and Research provides an essential foundation for pharmacy students and pharmacists globally. Covers the core information needed for pharmacy practice courses Includes multiple case studies and practical situations with 70% focused on practical clinical pharmacology knowledge Designed for educational settings, but also useful as a refresher for advanced students and researchers