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Mind Maps of Pharmacovigilance Basics

Mind Maps of Pharmacovigilance Basics
Author: Amrita Akhouri
Publisher: CreateSpace
Total Pages: 182
Release: 2015-02-04
Genre:
ISBN: 9781507894453

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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.


Mind Maps of Clinical Research Basics

Mind Maps of Clinical Research Basics
Author: Amrita Akhouri
Publisher:
Total Pages: 342
Release: 2018-04-09
Genre: Medical
ISBN: 9789387193376

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The concepts of Clinical Research have been depicted through mind maps in this book which makes the subject fundamentals very easy to understand and convenient to revise. The chapter on career in clinical research gives an insight into the main job roles currently known in this field along with the focus on how to build preparedness for job interviews. Hence, this book will be very helpful to the students as well as to the job seekers trying to make their career in the field of clinical research.


Drug Safety Data

Drug Safety Data
Author: Michael J. Klepper
Publisher: Jones & Bartlett Learning
Total Pages: 332
Release: 2011
Genre: Medical
ISBN: 0763769126

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Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides pharmaceutical scientists, researchers 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 premarketing risk assessment. This unique resource enhances the ability of pharmaceutical professionalsùthose with and without clinical trainingùto determine the risk of a drug or biologic­ ahead of its release, thereby reducing unnecessary jeopardy to the patient. Authors Dr. Michael Klepper and Dr. Barton Cobert, who together bring decades of pharmaceutical research and drug safety expertise, 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 provides 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 tipsàand 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)


Pharmacovigilance: A Practical Approach

Pharmacovigilance: A Practical Approach
Author: Thao Doan
Publisher: Elsevier Health Sciences
Total Pages: 228
Release: 2018-07-31
Genre: Medical
ISBN: 032358117X

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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

An Introduction to Pharmacovigilance
Author: Patrick Waller
Publisher: John Wiley & Sons
Total Pages: 192
Release: 2017-02-14
Genre: Medical
ISBN: 1119289785

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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.


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

Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)
Author: Cobert Barton
Publisher: World Scientific
Total Pages: 524
Release: 2019-04-10
Genre: Medical
ISBN: 9813279168

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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.


IAP Guidebook on Immunization 2018-2019

IAP Guidebook on Immunization 2018-2019
Author: Balasubramanian S
Publisher: Jaypee Brothers Medical Publishers
Total Pages: 533
Release: 2019-11-28
Genre: Medical
ISBN: 938958700X

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Mann's Pharmacovigilance

Mann's Pharmacovigilance
Author: Elizabeth B. Andrews
Publisher: John Wiley & Sons
Total Pages: 878
Release: 2014-03-24
Genre: Medical
ISBN: 1118820142

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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.


How to Read a Paper

How to Read a Paper
Author: Trisha Greenhalgh
Publisher: John Wiley & Sons
Total Pages: 285
Release: 2014-02-26
Genre: Medical
ISBN: 111880113X

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The best-selling introduction to evidence-based medicine In a clear and engaging style, How to Read a Paper demystifies evidence-based medicine and explains how to critically appraise published research and also put the findings into practice. An ideal introduction to evidence-based medicine, How to Read a Paper explains what to look for in different types of papers and how best to evaluate the literature and then implement the findings in an evidence-based, patient-centred way. Helpful checklist summaries of the key points in each chapter provide a useful framework for applying the principles of evidence-based medicine in everyday practice. This fifth edition has been fully updated with new examples and references to reflect recent developments and current practice. It also includes two new chapters on applying evidence-based medicine with patients and on the common criticisms of evidence-based medicine and responses. How to Read a Paper is a standard text for medical and nursing schools as well as a friendly guide for everyone wanting to teach or learn the basics of evidence-based medicine.


Principles of Pharmacovigilance

Principles of Pharmacovigilance
Author: S B Bhise
Publisher:
Total Pages: 280
Release: 2016-09-16
Genre: Fiction
ISBN: 9789386084897

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1 Introduction to adverse drug reactions 2 Introduction to pharmacovigilance 3 National and International scenario 4 Basic Terminologies used in pharmacovigilance 5 Information resources in pharmacovigilance 6 Establishing pharmacovigilance programme 7 Pharmacovigilance methods 8 Adverse drug reaction reporting 9 Signal detection risk assessment and management 10 Drug and disease classification