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Pharmacovigilance A Practical Approach

Pharmacovigilance  A Practical Approach
  • Author : Thao Doan
  • Publsiher : Elsevier Health Sciences
  • Release : 31 July 2018
  • ISBN : 032358117X
  • Pages : 228 pages
  • Rating : 4/5 from 21 ratings
GET THIS BOOKPharmacovigilance A Practical Approach

Summary:
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: A Practical Approach

Pharmacovigilance: A Practical Approach
  • Author : Thao Doan,Cheryl Renz,Fabio Lievano,Mondira Bhattacharya,Linda Scarazzini
  • Publisher : Elsevier Health Sciences
  • Release : 31 July 2018
GET THIS BOOKPharmacovigilance: A Practical Approach

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

Pharmacovigilance Medical Writing
  • Author : Justina Orleans-Lindsay
  • Publisher : John Wiley & Sons
  • Release : 22 June 2012
GET THIS BOOKPharmacovigilance Medical Writing

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


A Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines

A Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines
  • Author : World Health Organization
  • Publisher : World Health Organization
  • Release : 08 March 2021
GET THIS BOOKA Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines

This is a detailed manual giving a step-by-step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programs. There is an urgent need to develop robust pharmacovigilance systems for antiretrovirals particularly in resource-limited settings. This detailed manual gives a step by step approach to undertaking the pharmacovigilance of these medicines. Good pharmacovigilance will identify the risks in the shortest



A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines

A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines
  • Author : World Health Organization
  • Publisher : World Health Organization
  • Release : 08 March 2021
GET THIS BOOKA Practical Handbook on the Pharmacovigilance of Antimalarial Medicines

The Handbook 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


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

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk
  • Author : Michael J. Klepper,Barton Cobert
  • Publisher : Jones & Bartlett Publishers
  • Release : 25 October 2010
GET THIS BOOKDrug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk

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


An Introduction to Pharmacovigilance

An Introduction to Pharmacovigilance
  • Author : Patrick Waller,Mira Harrison-Woolrych
  • Publisher : John Wiley & Sons
  • Release : 14 February 2017
GET THIS BOOKAn Introduction to Pharmacovigilance

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


Mann's Pharmacovigilance

Mann's Pharmacovigilance
  • Author : Elizabeth B. Andrews,Nicholas Moore
  • Publisher : John Wiley & Sons
  • Release : 24 March 2014
GET THIS BOOKMann's Pharmacovigilance

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,


Clinical Pharmacy Education, Practice and Research

Clinical Pharmacy Education, Practice and Research
  • Author : Dixon Thomas
  • Publisher : Elsevier
  • Release : 23 November 2018
GET THIS BOOKClinical Pharmacy Education, Practice and Research

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


The Role of the Pharmacist in Patient Care

The Role of the Pharmacist in Patient Care
  • Author : Abdul Kader Mohiuddin
  • Publisher : Universal-Publishers
  • Release : 08 March 2021
GET THIS BOOKThe Role of the Pharmacist in Patient Care

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


Therapeutic Risk Management of Medicines

Therapeutic Risk Management of Medicines
  • Author : Stephen J. Mayall,Anjan Swapu Banerjee
  • Publisher : Elsevier
  • Release : 16 April 2014
GET THIS BOOKTherapeutic Risk Management of Medicines

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


Cobert's Manual of Drug Safety and Pharmacovigilance

Cobert's Manual of Drug Safety and Pharmacovigilance
  • Author : Barton Cobert,President Blcmd Associates LLC Westfield New Jersey Barton Cobert
  • Publisher : Jones & Bartlett Publishers
  • Release : 01 April 2011
GET THIS BOOKCobert's Manual of Drug Safety and Pharmacovigilance

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


Pharmacovigilance in the European Union

Pharmacovigilance in the European Union
  • Author : Michael Kaeding,Julia Schmälter,Christoph Klika
  • Publisher : Springer
  • Release : 20 February 2017
GET THIS BOOKPharmacovigilance in the European Union

This book is open access under a CC BY 4.0 license. The book presents the results of an in-depth comparative study assessing the implementation of the EU Pharmacovigilance Directive in six EU Member States. By going beyond legal transposition and instead focusing on practical implementation, this study aims to close a gap in EU compliance research. Based on qualitative interviews with relevant actors in Germany, Poland, Portugal, France, Finland and the UK, the authors identify perceived challenges and best-practices, issue recommendations,


Practical Guide to Clinical Data Management, Third Edition

Practical Guide to Clinical Data Management, Third Edition
  • Author : Susanne Prokscha
  • Publisher : CRC Press
  • Release : 26 October 2011
GET THIS BOOKPractical Guide to Clinical Data Management, Third Edition

The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, the third edition of Practical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using


Clinical Trials Risk Management

Clinical Trials Risk Management
  • Author : Martin Robinson,Simon Cook
  • Publisher : CRC Press
  • Release : 12 October 2005
GET THIS BOOKClinical Trials Risk Management

Drug development is risky business. It is against the backdrop of huge financial, scientific, technical and medical risks that a clinical trials manager is expected to function, effectively identifying and managing all project risks, to deliver a successful outcome. Focusing on the day-to-day needs of a clinical trials manager, Clinical Trials Risk Management explains the key concepts and principles of risk management, as well as showing how best to how to apply them directly to 'real life' clinical trial situations.