Download or read book Cobert s Manual Of Drug Safety And Pharmacovigilance Third Edition written by Cobert Barton and published by World Scientific. This book was released on 2019-04-10 with total page 524 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Cobert s Manual of Drug Safety and Pharmacovigilance written by Barton Cobert and published by Jones & Bartlett Publishers. This book was released on 2011-04 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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, pharmacology, 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.
Download or read book Cobert s Manual of Drug Safety and Pharmacovigilance written by Barton Cobert and published by . This book was released on 2019-04-10 with total page 524 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Cobert s Manual of Drug Safety and Pharmacovigilance Third Edition written by Barton Cobert and published by World Scientific Publishing Company. This book was released on 2019-03-20 with total page 524 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Drug Safety Data written by Michael J. Klepper and published by Jones & Bartlett Learning. This book was released on 2011 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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)
Download or read book Manual of Drug Safety and Pharmacovigilance written by Barton Cobert and published by Jones & Bartlett Learning. This book was released on 2008-07-07 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: An ideal resource for all pharmacists, hospital clinicians, nurses, administrators, medical liability lawyers, and others in the healthcare industry, this comprehensive and practical guide provides essential information on recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.
Download or read book Practical Drug Safety from A to Z written by Barton Cobert and published by Jones & Bartlett Publishers. This book was released on 2009-10-06 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Practical Drug Safety from A to Z is an alphabetical guide to drug safety monitoring (pharmacovigilance), covering literally, the "A to Z" of maintaining drug safety. Written by experts in the field, this book is a perfect to companion to the Manual of Drug Safety and Pharmacovigilance and an essential reference for pharmacists, pharmacologists, hospital administrators, medical liability lawyers, and others.
Download or read book Pharmacovigilance written by Ravi N. Humbarwadi and published by CreateSpace. This book was released on 2014-03-21 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designed for the practice of professional pharmacovigilance. MedDRA, FDA, EMEA, Eudravigilance, Regulatory framework submissions and timelines, GVP - 2012, Narrative Writing - Rules & Format, ARGUS, Signal Detection. Special Features. The Pharmacovigilance Interview: Can help you clear job interviews and start a career or get that better job. An exhaustive yet usable list of IME: Can help a professional differentiate between serious and non-serious cases and improve regulatory submission compliance.
Download or read book Pharmacovigilance Medical Writing written by Justina Orleans-Lindsay and published by John Wiley & Sons. This book was released on 2012-06-22 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book An Introduction to Pharmacovigilance written by Patrick Waller and published by John Wiley & Sons. This book was released on 2017-05-01 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Pharmacovigilance A Practical Approach written by Thao Doan and published by Elsevier Health Sciences. This book was released on 2018-07-31 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Mann s Pharmacovigilance written by Elizabeth B. Andrews and published by John Wiley & Sons. This book was released on 2014-03-24 with total page 878 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Understanding Pharmacoepidemiology written by Yi Yang and published by McGraw Hill Professional. This book was released on 2010-12-31 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: A concise introduction to the study of medication utilization and safety in large populations of people Understanding Pharmacoepidemiology is a clear, engagingly written roadmap to mastering the important concepts and methods of pharmacoepidemiology. It explains what pharmacoepidemiology is, how pharmacoepidemiology studies are conducted, and how to interpret findings. You will learn the importance of pharmacoepidemiology, basic terminology used in research, and the data sources, study designs, and statistical analyses employed in pharmacoepidemiology research. Upon completing Understanding Pharmacoepidemiology you will have a better understanding of how to evaluate the associations between medication utilization and outcomes. Each chapter includes these valuable learning aids: A list of learning objectives Case studies or examples Discussion questions Tables and Figures You will also find a glossary of important words and terms. The content you need to understand the concepts and methods of pharmacoepidemiology: Introduction to Pharmacoepidemiology: Principles of Epidemiology Applied to the Study of Medication Use, Study Designs in Pharmacoepidemiology: Using Secondary Data in Pharmacoepidemiology; Biostatistics and Pharmacoepidemiology: Other Methodological Issues; Evaluation of Pharmacoepidemiology Literature; Medication Utilization Patterns; Medication Safety and Pharmacovigilance; and FDA Perspectives on Post-market Drug Safety.
Download or read book A Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines written by World Health Organization and published by World Health Organization. This book was released on 2009 with total page 146 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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 programmes. A number of WHO publications are available that provide a background to pharmacovigilance and, as far as possible, that material will not be repeated here."--Publisher's description.
Download or read book Textbook of Pharmacovigilance written by SK Gupta and published by Jaypee Brothers Medical Publishers. This book was released on 2018-12-24 with total page 638 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Download or read book Pharmacovigilance written by Ronald D. Mann and published by John Wiley & Sons. This book was released on 2007-02-06 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by an international team of outstanding editors andcontributors, Pharmacovigilance, 2ndEdition is the definitive text on this importantsubject. The new edition has been completely revised andupdated to include the latest theoretical and practical aspects ofpharmacovigilance including legal issues, drug regulatoryrequirements, methods of signal generation, reporting schemes andpharmacovigilance in selected system-organ classes. . The editors and contributors are of excellent standing withinthe pharmacovigilance community The text provides exemplary coverage of all the relevantissues The definitive book on the subject
