Pharmacovigilance Essentials
Author : Mukesh Nandave
Publisher : Springer Nature
Page : 478 pages
File Size : 37,33 MB
Release :
Category :
ISBN : 9819989493
Essentials of Pharmacovigilance
Author : Himanshu Baweja
Publisher : Jaypee Brothers Medical Publishers Pvt. Limited
Page : 0 pages
File Size : 23,74 MB
Release : 2018-04-30
Category : Medical
ISBN : 9789352704965
Book Description
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
An Introduction to Pharmacovigilance
Author : Patrick Waller
Publisher : John Wiley & Sons
Page : 194 pages
File Size : 16,13 MB
Release : 2017-05-01
Category : Medical
ISBN : 1119289742
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.
Pharmacovigilance: A Practical Approach
Author : Thao Doan
Publisher : Elsevier Health Sciences
Page : 229 pages
File Size : 11,15 MB
Release : 2018-07-31
Category : Medical
ISBN : 032358117X
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. - 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.
Mind Maps of Pharmacovigilance Basics
Author : Amrita Akhouri
Publisher : CreateSpace
Page : 182 pages
File Size : 45,82 MB
Release : 2015-02-04
Category :
ISBN : 9781507894453
Book Description
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 : Barton Cobert
Publisher : World Scientific
Page : 525 pages
File Size : 45,82 MB
Release : 2019-04-09
Category : Medical
ISBN : 9813279168
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.Related Link(s)
Mann's Pharmacovigilance
Author : Elizabeth B. Andrews
Publisher : John Wiley & Sons
Page : 878 pages
File Size : 25,26 MB
Release : 2014-03-24
Category : Medical
ISBN : 1118820142
Book Description
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 Medical Writing
Author : Justina Orleans-Lindsay
Publisher : John Wiley & Sons
Page : 182 pages
File Size : 37,51 MB
Release : 2012-06-22
Category : Medical
ISBN : 1118302060
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.
Drug Safety in Developing Countries
Author : Yaser Mohammed Al-Worafi
Publisher : Academic Press
Page : 656 pages
File Size : 42,10 MB
Release : 2020-06-03
Category : Medical
ISBN : 0128204125
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
Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk
Author : Michael J. Klepper
Publisher : Jones & Bartlett Publishers
Page : 332 pages
File Size : 20,80 MB
Release : 2010-09-15
Category : Medical
ISBN : 1449671551
Book Description
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)
