Author: Amrita Akhouri
Publisher: CreateSpace
ISBN: 9781507894453
Category :
Languages : en
Pages : 182
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.
Mind Maps of Pharmacovigilance Basics
Author: Amrita Akhouri
Publisher: CreateSpace
ISBN: 9781507894453
Category :
Languages : en
Pages : 182
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.
Publisher: CreateSpace
ISBN: 9781507894453
Category :
Languages : en
Pages : 182
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.
Mind Maps of Clinical Research Basics
Author: Amrita Akhouri
Publisher:
ISBN: 9789387193376
Category : Medical
Languages : en
Pages : 342
Book Description
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.
Publisher:
ISBN: 9789387193376
Category : Medical
Languages : en
Pages : 342
Book Description
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: How to Analyze, Summarize and Interpret to Determine Risk
Author: Michael J. Klepper
Publisher: Jones & Bartlett Publishers
ISBN: 1449671551
Category : Medical
Languages : en
Pages : 332
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)
Publisher: Jones & Bartlett Publishers
ISBN: 1449671551
Category : Medical
Languages : en
Pages : 332
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)
Pharmacovigilance: A Practical Approach
Author: Thao Doan
Publisher: Elsevier Health Sciences
ISBN: 032358117X
Category : Medical
Languages : en
Pages : 229
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.
Publisher: Elsevier Health Sciences
ISBN: 032358117X
Category : Medical
Languages : en
Pages : 229
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.
An Introduction to Pharmacovigilance
Author: Patrick Waller
Publisher: John Wiley & Sons
ISBN: 1119289742
Category : Medical
Languages : en
Pages : 194
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.
Publisher: John Wiley & Sons
ISBN: 1119289742
Category : Medical
Languages : en
Pages : 194
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.
Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)
Author: Barton Cobert
Publisher: World Scientific
ISBN: 9813279168
Category : Medical
Languages : en
Pages : 525
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)
Publisher: World Scientific
ISBN: 9813279168
Category : Medical
Languages : en
Pages : 525
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)
How to Read a Paper
Author: Trisha Greenhalgh
Publisher: John Wiley & Sons
ISBN: 111880113X
Category : Medical
Languages : en
Pages : 285
Book Description
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.
Publisher: John Wiley & Sons
ISBN: 111880113X
Category : Medical
Languages : en
Pages : 285
Book Description
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.
Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy
Author: Mahmoud Aljurf
Publisher: Springer Nature
ISBN: 3030644928
Category : Medical
Languages : en
Pages : 189
Book Description
This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.
Publisher: Springer Nature
ISBN: 3030644928
Category : Medical
Languages : en
Pages : 189
Book Description
This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.
Ten years in public health 2007-2017
Author: Margaret Chan
Publisher: World Health Organization
ISBN: 924151244X
Category : Business & Economics
Languages : en
Pages : 152
Book Description
Ten years in public health 2007-2017 chronicles the evolution of global public health over the decade that Margaret Chan served as Director-General at the World Health Organization. This series of chapters evaluates successes setbacks and enduring challenges during the decade. They show what needs to be done when progress stalls or new threats emerge. The chapters show how WHO technical leadership can get multiple partners working together in tandem under coherent strategies. The importance of country leadership and community engagement is stressed repeatedly throughout the chapters. Together we have made tremendous progress. Health and life expectancy have improved nearly everywhere. Millions of lives have been saved. The number of people dying from malaria and HIV has been cut in half. WHO efforts to stop TB saved 49 million lives since the start of this century. In 2015 the number of child deaths dropped below 6 million for the first time a 50% decrease in annual deaths since 1990. Every day 19 000 fewer children die. We are able to count these numbers because of the culture of measurement and accountability instilled in WHO. These chapters tell a powerful story of global challenges and how they have been overcome. In a world facing considerable uncertainty international health development is a unifying – and uplifting – force for the good of humanity.
Publisher: World Health Organization
ISBN: 924151244X
Category : Business & Economics
Languages : en
Pages : 152
Book Description
Ten years in public health 2007-2017 chronicles the evolution of global public health over the decade that Margaret Chan served as Director-General at the World Health Organization. This series of chapters evaluates successes setbacks and enduring challenges during the decade. They show what needs to be done when progress stalls or new threats emerge. The chapters show how WHO technical leadership can get multiple partners working together in tandem under coherent strategies. The importance of country leadership and community engagement is stressed repeatedly throughout the chapters. Together we have made tremendous progress. Health and life expectancy have improved nearly everywhere. Millions of lives have been saved. The number of people dying from malaria and HIV has been cut in half. WHO efforts to stop TB saved 49 million lives since the start of this century. In 2015 the number of child deaths dropped below 6 million for the first time a 50% decrease in annual deaths since 1990. Every day 19 000 fewer children die. We are able to count these numbers because of the culture of measurement and accountability instilled in WHO. These chapters tell a powerful story of global challenges and how they have been overcome. In a world facing considerable uncertainty international health development is a unifying – and uplifting – force for the good of humanity.
Countering the Problem of Falsified and Substandard Drugs
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309269393
Category : Medical
Languages : en
Pages : 377
Book Description
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.
Publisher: National Academies Press
ISBN: 0309269393
Category : Medical
Languages : en
Pages : 377
Book Description
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.