Mind Maps Of Pharmacovigilance Basics
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Mind Maps Of Pharmacovigilance Basics
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Author : Amrita Akhouri
language : en
Publisher: CreateSpace
Release Date : 2015-02-04
Mind Maps Of Pharmacovigilance Basics written by Amrita Akhouri and has been published by CreateSpace this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-02-04 with categories.
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
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Author : Amrita Akhouri
language : en
Publisher:
Release Date : 2018-04-09
Mind Maps Of Clinical Research Basics written by Amrita Akhouri and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-04-09 with Medical categories.
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
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Author : Michael J. Klepper
language : en
Publisher: Jones & Bartlett Learning
Release Date : 2010-10-25
Drug Safety Data written by Michael J. Klepper and has been published by Jones & Bartlett Learning this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-10-25 with Medical categories.
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)
Pharmacovigilance A Practical Approach
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Author : Thao Doan
language : en
Publisher: Elsevier Health Sciences
Release Date : 2018-07-31
Pharmacovigilance A Practical Approach written by Thao Doan and has been published by Elsevier Health Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-07-31 with Medical categories.
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
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Author : Justina Orleans-Lindsay
language : en
Publisher: John Wiley & Sons
Release Date : 2012-06-22
Pharmacovigilance Medical Writing written by Justina Orleans-Lindsay and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-06-22 with Medical categories.
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
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Author : Patrick Waller
language : en
Publisher: John Wiley & Sons
Release Date : 2017-02-14
An Introduction To Pharmacovigilance written by Patrick Waller and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-14 with Medical categories.
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
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Author : Cobert Barton
language : en
Publisher: World Scientific
Release Date : 2019-04-10
Cobert S Manual Of Drug Safety And Pharmacovigilance Third Edition written by Cobert Barton and has been published by World Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-10 with Medical categories.
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.
Cobert S Manual Of Drug Safety And Pharmacovigilance
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Author : Barton Cobert
language : en
Publisher: Jones & Bartlett Publishers
Release Date : 2011-04
Cobert S Manual Of Drug Safety And Pharmacovigilance written by Barton Cobert and has been published by Jones & Bartlett Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-04 with Medical categories.
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.
Principles Of Pharmacovigilance
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Author : S B Bhise
language : en
Publisher:
Release Date : 2016-09-16
Principles Of Pharmacovigilance written by S B Bhise and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-09-16 with Fiction categories.
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
Countering The Problem Of Falsified And Substandard Drugs
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2013-06-20
Countering The Problem Of Falsified And Substandard Drugs written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-06-20 with Medical categories.
The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.