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Pharmacovigilance A Practical Approach

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Pharmacovigilance A Practical Approach

Pharmacovigilance  A Practical Approach Book
Author : Thao Doan,Cheryl Renz,Fabio Lievano,Mondira Bhattacharya,Linda Scarazzini
Publisher : Elsevier Health Sciences
Release : 2018-07-31
ISBN : 032358117X
Language : En, Es, Fr & De

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Book Description :

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.

Practical Aspects of Signal Detection in Pharmacovigilance

Practical Aspects of Signal Detection in Pharmacovigilance Book
Author : Anonim
Publisher : Cioms
Release : 2010
ISBN : 9789290360827
Language : En, Es, Fr & De

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Book Description :

In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.

Pharmacovigilance Medical Writing

Pharmacovigilance Medical Writing Book
Author : Justina Orleans-Lindsay
Publisher : John Wiley & Sons
Release : 2012-06-22
ISBN : 1118302060
Language : En, Es, Fr & De

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Book Description :

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.

An Introduction to Pharmacovigilance

An Introduction to Pharmacovigilance Book
Author : Patrick Waller,Mira Harrison-Woolrych
Publisher : John Wiley & Sons
Release : 2017-02-14
ISBN : 1119289785
Language : En, Es, Fr & De

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Book Description :

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.

The Role of the Pharmacist in Patient Care

The Role of the Pharmacist in Patient Care Book
Author : Abdul Kader Mohiuddin
Publisher : Universal-Publishers
Release : 2020
ISBN : 1627343083
Language : En, Es, Fr & De

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Book Description :

The goal of a high quality, cost-effective and accessible health care for patients is achieved through constructing a team-based and patient-centered health care delivery system. The expanded role of pharmacists uplifts them to patient care from dispensing and manufacturing or marketing of drugs. Along with doctors and allied health professionals, pharmacists are increasingly recognized as an integral part of the patient care team. Furthermore, colleges of pharmacy need to revise and up-date their curricula to accommodate the progressively increasing development in the pharmaceutical education and the evolving new roles of practicing pharmacists in patient care settings. This book focuses on the expanded role of the pharmacists in total patient care including prescribing, dispensing, compounding, administering and monitoring of drugs at home, hospital, community, hospice, critical care, changeover and other care settings. The sector is emerging in both developed and under-developed countries. Overburdened by patient loads and the explosion of new drugs physicians turned to pharmacists more and more for drug information especially within institutional settings. And today’s patient care pharmacists are taking more interests in medication review and reconciliation, patient education and counseling, creating drug therapy regimen and monitoring compliance. The purpose of this book is to guide the pharmacists in their daily interactions with patients and to ensure collaboration with other health professionals. The contents are mostly based on recently published articles related to patient care, with most recent ideas and activities followed by the patient care pharmacists around the globe. However, a pharmacist implements the care plan in collaboration with other health care professionals and the patient or caregiver. Along with professional guidelines, the book discusses the concepts and best practices of patient interaction, patient rights, and ethical decision-making for the professional pharmacist, apprentice and student. In every chapter, the role of pharmacists in that chapter specific issues are detailed explicitly so that a professional pharmacist or a student can figure out his or her do’s and don’ts in that specific situation. Moreover, further reading references are listed as future recommendations. So, the book is an archive of potential references too. Among so many books about patient care, either doctors’ or nurses’ roles are highlighted. The proposed book highlights the pharmacists’ roles and responsibilities to the most, separated from those of doctors and nurses, with the most recent information obtained from most publications in several journals, books, bulletins, newsletter, magazines etc.

A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines

A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines Book
Author : World Health Organization
Publisher : World Health Organization
Release : 2008
ISBN : 9241547499
Language : En, Es, Fr & De

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Book Description :

The Handbook on the Pharmacovigilance of antimalarial medicines is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antimalarials. It is intended to be a source of practical advice for Pharmacovigilance Centres. It provides information on spontaneous reporting of adverse drug reactions as a complement to other WHO publications. In addition, it provides details on how to conduct cohort event monitoring, which is a method of active safety surveillance collecting information on all adverse events occurring after treatment. It also details how to perform causality assessment and signal identification, applicable to both methods of surveillance.

Lippincott Illustrated Reviews Immunology

Lippincott Illustrated Reviews  Immunology Book
Author : Thao Doan,Fabio Lievano,Susan M. Viselli,Michelle Swanson-Mungerson
Publisher : Lippincott Williams & Wilkins
Release : 2021-01-14
ISBN : 1975151313
Language : En, Es, Fr & De

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Book Description :

Lippincott® Illustrated Reviews: Immunology, 3rd Edition, offers an engaging, vividly illustrated presentation and all of the popular learning features of the Lippincott® Illustrated Review series to reinforce essential immunology concepts and connect basic science to real-life clinical situations. Like other titles in this series, this dynamic resource follows an intuitive outline organization and boasts a wealth of vibrant illustrations and study aids that clarify complex information and ensure retention. Whether used as a review text for a short immunology course or paired with Lippincott® Illustrated Reviews: Microbiology for a combined microbiology/immunology course, this revised and updated edition familiarizes readers with the latest practices in immunology and emphasizes clinical application to deliver unparalleled preparation for exams and clinical practice.

Cobert s Manual Of Drug Safety And Pharmacovigilance Third Edition

Cobert s Manual Of Drug Safety And Pharmacovigilance  Third Edition  Book
Author : Cobert Barton,Gregory William,Thomas Jean-loup
Publisher : World Scientific
Release : 2019-04-10
ISBN : 9813279168
Language : En, Es, Fr & De

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Book Description :

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.

Drug Safety in Developing Countries

Drug Safety in Developing Countries Book
Author : Yaser Mohammed Al-Worafi
Publisher : Academic Press
Release : 2020-06-03
ISBN : 0128204125
Language : En, Es, Fr & De

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Book Description :

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

Therapeutic Risk Management of Medicines

Therapeutic Risk Management of Medicines Book
Author : Stephen J. Mayall,Anjan Swapu Banerjee
Publisher : Elsevier
Release : 2014-04-16
ISBN : 1908818271
Language : En, Es, Fr & De

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Book Description :

Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders. A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US. This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts. An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicines A number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan) A comprehensive guide for performing risk management more effectively throughout a product’s life-cycle

Quantitative Drug Safety and Benefit Risk Evaluation

Quantitative Drug Safety and Benefit Risk Evaluation Book
Author : William Wang,Melvin Munsaka,James Buchanan,Judy Li
Publisher : CRC Press
Release : 2021-12-29
ISBN : 0429949995
Language : En, Es, Fr & De

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Book Description :

Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to better understand the scope of product risks. Written to be accessible not only to statisticians but also to safety scientists with a quantitative interest, this book aims to bridge the gap in knowledge between medical and statistical fields creating a truly multi-disciplinary approach that is very much needed for 21st century safety evaluation.

Communicating about Risks and Safe Use of Medicines

Communicating about Risks and Safe Use of Medicines Book
Author : Priya Bahri
Publisher : Springer Nature
Release : 2020-06-17
ISBN : 9811530130
Language : En, Es, Fr & De

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Book Description :

At the core of this book lies the question how to approach medicines, risks and communication as a researcher - or anybody planning and evaluating a communication intervention, or wanting to understand communication events in private and the media. With a view to tackle current shortcomings of communication systems and processes for improved implementation, patient satisfaction and health outcomes, a multilayered approach is presented. This combines multiple data types and methods to obtain a wider and deeper understanding of the major parties and their interactions, as well as the healthcare, social and political contexts of information flows, how they interfere and which impact they have. Illustrated with real life experiences of safety concerns with medicines, worldwide active experts discuss the methods and contributions their disciplines can offer. With considerations on terminologies, tabulated overviews on communication types and outcomes, a patient-centred vision and plain language for non-medical readers, the book creates a platform for multidisciplinary collaborations amongst researchers as well as practitioners from communications, healthcare, the social sciences and pharmacovigilance. Importantly, it advocates for an active role of patients and highlights the achievements and aspirations of patient organisations. Finally, the book suggests establishing an inclusive discipline of humanities and epidemiology of medicinal product risk communication to realise full research potential. The authors are driven by the curiosity for communication as the most human behaviour, and as good health is amongst the basic human needs, medicinal product risk communication is an exciting research field of high global relevance.

Clinical Pharmacy Education Practice and Research

Clinical Pharmacy Education  Practice and Research Book
Author : Dixon Thomas
Publisher : Elsevier
Release : 2018-11-23
ISBN : 0128142774
Language : En, Es, Fr & De

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Book Description :

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

Cobert s Manual of Drug Safety and Pharmacovigilance

Cobert s Manual of Drug Safety and Pharmacovigilance Book
Author : Barton Cobert,President Blcmd Associates LLC Westfield New Jersey Barton Cobert
Publisher : Jones & Bartlett Publishers
Release : 2011-04
ISBN : 0763791601
Language : En, Es, Fr & De

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Book Description :

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.

Trends and Innovations in Information Systems and Technologies

Trends and Innovations in Information Systems and Technologies Book
Author : Álvaro Rocha,Hojjat Adeli,Luís Paulo Reis,Sandra Costanzo,Irena Orovic,Fernando Moreira
Publisher : Springer Nature
Release : 2020-05-17
ISBN : 3030456978
Language : En, Es, Fr & De

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Book Description :

This book gathers selected papers presented at the 2020 World Conference on Information Systems and Technologies (WorldCIST’20), held in Budva, Montenegro, from April 7 to 10, 2020. WorldCIST provides a global forum for researchers and practitioners to present and discuss recent results and innovations, current trends, professional experiences with and challenges regarding various aspects of modern information systems and technologies. The main topics covered are A) Information and Knowledge Management; B) Organizational Models and Information Systems; C) Software and Systems Modeling; D) Software Systems, Architectures, Applications and Tools; E) Multimedia Systems and Applications; F) Computer Networks, Mobility and Pervasive Systems; G) Intelligent and Decision Support Systems; H) Big Data Analytics and Applications; I) Human–Computer Interaction; J) Ethics, Computers & Security; K) Health Informatics; L) Information Technologies in Education; M) Information Technologies in Radiocommunications; and N) Technologies for Biomedical Applications.

Biologics Biosimilars and Biobetters

Biologics  Biosimilars  and Biobetters Book
Author : Iqbal Ramzan
Publisher : John Wiley & Sons
Release : 2021-01-05
ISBN : 1119564662
Language : En, Es, Fr & De

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Book Description :

A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists

Pharmacoepidemiology and Pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance Book
Author : Sabrina Nour,Gilles Plourde
Publisher : Academic Press
Release : 2018-10-17
ISBN : 012816381X
Language : En, Es, Fr & De

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Book Description :

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

Medical Pharmacology and Therapeutics E Book

Medical Pharmacology and Therapeutics E Book Book
Author : Derek G. Waller,Tony Sampson
Publisher : Elsevier Health Sciences
Release : 2013-08-07
ISBN : 0702055034
Language : En, Es, Fr & De

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Book Description :

This book covers all the pharmacology you need, from basic science pharmacology and pathophysiology, through to clinical pharmacology to therapeutics, in line with the integrated approach of new medical curricula. The first section covers the basic principles, and the rest is organised by body systems. The book ends with sections on toxicity and prescribing practice. Integrates basic science pharmacology, clinical pharmacology and therapeutics Brief review of pathophysiology of major diseases Case histories and multiple choice questions (and answers) Tabular presentation of all common drugs within each class Section on further reading Kinetics chapter simplified with more practical examples Includes more on genetic issues Drug tables made more concise to make information more accessible Fully updated to reflect current clinical practice

Practical Approaches to Risk Minimisation for Medicinal Products

Practical Approaches to Risk Minimisation for Medicinal Products Book
Author : World Health Organization
Publisher : Unknown
Release : 2015-03-02
ISBN : 9789290360841
Language : En, Es, Fr & De

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Book Description :

Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large. Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of risk, "risk minimization" is used as an umbrella term for the prevention or mitigation of an undesirable outcome. Risk management always includes tools for "routine risk minimization" such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects. Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need "additional risk minimization," select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable. Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimization, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life.

Pharmacoepidemiology

Pharmacoepidemiology Book
Author : Brian L. Strom,Stephen E. Kimmel,Sean Hennessy
Publisher : John Wiley & Sons
Release : 2019-10-18
ISBN : 1119413370
Language : En, Es, Fr & De

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Book Description :

This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.