Pharmacovigilance  A Practical Approach Book

Pharmacovigilance A Practical Approach


  • Author : Thao Doan
  • Publisher : Elsevier Health Sciences
  • Release Date : 2018-07-31
  • Genre: Medical
  • Pages : 228
  • ISBN 10 : 9780323581172

DOWNLOAD BOOK
Pharmacovigilance A Practical Approach 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.

An Introduction to Pharmacovigilance Book

An Introduction to Pharmacovigilance


  • Author : Patrick Waller
  • Publisher : John Wiley & Sons
  • Release Date : 2017-02-14
  • Genre: Medical
  • Pages : 192
  • ISBN 10 : 9781119289784

DOWNLOAD BOOK
An Introduction to Pharmacovigilance 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 Medical Writing Book

Pharmacovigilance Medical Writing


  • Author : Justina Orleans-Lindsay
  • Publisher : John Wiley & Sons
  • Release Date : 2012-06-22
  • Genre: Medical
  • Pages : 288
  • ISBN 10 : 9781118302064

DOWNLOAD BOOK
Pharmacovigilance Medical Writing 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.

Practical Aspects of Signal Detection in Pharmacovigilance Book

Practical Aspects of Signal Detection in Pharmacovigilance


  • Author : Anonim
  • Publisher : Cioms
  • Release Date : 2010
  • Genre: Health & Fitness
  • Pages : 143
  • ISBN 10 : 9290360828

DOWNLOAD BOOK
Practical Aspects of Signal Detection in Pharmacovigilance Excerpt :

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.

The Role of the Pharmacist in Patient Care Book
Score: 4
From 15 Ratings

The Role of the Pharmacist in Patient Care


  • Author : Abdul Kader Mohiuddin
  • Publisher : Universal-Publishers
  • Release Date : 2020
  • Genre: Medical
  • Pages : 690
  • ISBN 10 : 9781627343084

DOWNLOAD BOOK
The Role of the Pharmacist in Patient Care Excerpt :

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

Cobert s Manual Of Drug Safety And Pharmacovigilance  Third Edition  Book

Cobert s Manual Of Drug Safety And Pharmacovigilance Third Edition


  • Author : Cobert Barton
  • Publisher : World Scientific
  • Release Date : 2019-04-10
  • Genre: Medical
  • Pages : 524
  • ISBN 10 : 9789813279162

DOWNLOAD BOOK
Cobert s Manual Of Drug Safety And Pharmacovigilance Third Edition 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.

A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines Book

A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines


  • Author : World Health Organization
  • Publisher : World Health Organization
  • Release Date : 2008
  • Genre: Medical
  • Pages : 121
  • ISBN 10 : 9789241547499

DOWNLOAD BOOK
A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines Excerpt :

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.

Drug Safety in Developing Countries Book

Drug Safety in Developing Countries


  • Author : Yaser Mohammed Al-Worafi
  • Publisher : Academic Press
  • Release Date : 2020-06-03
  • Genre: Business & Economics
  • Pages : 686
  • ISBN 10 : 9780128204122

DOWNLOAD BOOK
Drug Safety in Developing Countries 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

Quantitative Drug Safety and Benefit Risk Evaluation Book

Quantitative Drug Safety and Benefit Risk Evaluation


  • Author : William Wang
  • Publisher : CRC Press
  • Release Date : 2021-12-29
  • Genre: Mathematics
  • Pages : 408
  • ISBN 10 : 9780429949999

DOWNLOAD BOOK
Quantitative Drug Safety and Benefit Risk Evaluation Excerpt :

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 Book

Communicating about Risks and Safe Use of Medicines


  • Author : Priya Bahri
  • Publisher : Springer Nature
  • Release Date : 2020-06-17
  • Genre: Medical
  • Pages : 504
  • ISBN 10 : 9789811530135

DOWNLOAD BOOK
Communicating about Risks and Safe Use of Medicines Excerpt :

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.

Therapeutic Risk Management of Medicines Book

Therapeutic Risk Management of Medicines


  • Author : Stephen J. Mayall
  • Publisher : Elsevier
  • Release Date : 2014-04-16
  • Genre: Medical
  • Pages : 448
  • ISBN 10 : 9781908818270

DOWNLOAD BOOK
Therapeutic Risk Management of Medicines Excerpt :

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

Clinical Pharmacy Education  Practice and Research Book

Clinical Pharmacy Education Practice and Research


  • Author : Dixon Thomas
  • Publisher : Elsevier
  • Release Date : 2018-11-23
  • Genre: Business & Economics
  • Pages : 540
  • ISBN 10 : 9780128142776

DOWNLOAD BOOK
Clinical Pharmacy Education Practice and Research 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

Trends and Innovations in Information Systems and Technologies Book

Trends and Innovations in Information Systems and Technologies


  • Author : Álvaro Rocha
  • Publisher : Springer Nature
  • Release Date : 2020-05-17
  • Genre: Technology & Engineering
  • Pages : 615
  • ISBN 10 : 9783030456979

DOWNLOAD BOOK
Trends and Innovations in Information Systems and Technologies Excerpt :

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.

Pharmacoepidemiology and Pharmacovigilance Book

Pharmacoepidemiology and Pharmacovigilance


  • Author : Sabrina Nour
  • Publisher : Academic Press
  • Release Date : 2018-10-17
  • Genre: Medical
  • Pages : 144
  • ISBN 10 : 9780128163818

DOWNLOAD BOOK
Pharmacoepidemiology and Pharmacovigilance 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

Cobert s Manual of Drug Safety and Pharmacovigilance Book

Cobert s Manual of Drug Safety and Pharmacovigilance


  • Author : Barton Cobert
  • Publisher : Jones & Bartlett Publishers
  • Release Date : 2011-04
  • Genre: Medical
  • Pages : 431
  • ISBN 10 : 9780763791605

DOWNLOAD BOOK
Cobert s Manual of Drug Safety and Pharmacovigilance 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.