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 Drug Safety Data written by Michael J. Klepper and published by Jones & Bartlett Learning. This book was released on 2010-10-25 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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)
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 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
Download or read book Clinical Research and Pharmacovigilance written by Ravi Humbarwadi and published by Createspace Independent Publishing Platform. This book was released on 2016-01-04 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: CLINICAL RESEARCH & CLINICAL TRIALS1. NEW DRUG DEVELOPMENT2. HISTORICAL EVENTS3. GOOD CLINICAL PRACTICE - ICH GCP4. CLINICAL TRIAL DESIGN5. SERIOUS ADVERSE EVENT - SAE6. SITE7. PHARMACODYNAMICS8. PHARMACOKINETICS9. BIOAVAILABILITY10. BIOEQUIVALENCE11. QC AND QA IN CLINICAL TRIALS12. CLINICAL DATA MANAGEMENT13. PHARMACOVIGILANCE14. GIPV - ONLINEPHARMACOVIGILANCE1. INTRODUCTION2. NEED FOR PHARMACOVIGILANCE3. DEFINITIONS4. TYPES OF REPORTS5. REPORTING PROCESS6. SPONTANEOUS REPORTS7. TIME FRAMES FOR REGULATORY REPORTING8. CIOMS FORM9. MEDDRA10. MEDDRA - A PERSPECTIVE11. WHO DRUG DICTIONARYVE12. ACTION TAKEN, DC AND RC13. CAUSALITY ASSESSMENT14. UNBLINDING & SUSAR15. POST TREATMENT AND PRE-TREATMENT STUDY16. WORKFLOW17. THE PHARMACOVIGILANCE SYSTEM - EUDRAVIGILANCE.18. EMEA- GVP19. FDA: ADJUDICATION AND ADVISORY PANEL20. BACK TO THE FUTURE: VIOXX, MEDIATOR & THALIDOMIDE21. REGULATION AND DIRECTIVE ON PHARMACOVIGILANCE22. ASSESSMENT OF SERIOUSNESS FROM SOCIAL MEDIA23. SIGNAL DETECTION24. PROCESS OF SIGNAL DETECTION25. ARGUS 26. NARRATIVE WRITING - RULES & FORMAT27. IMPORTANT MEDICAL EVENT LIST28. GLOSSARY29. THE PHARMACOVIGILANCE INTERVIEW30. SERIOUS VS NON-SERIOUS: CASE STUDY & THUMB RULES
Download or read book Clinical Pharmacy Education Practice and Research written by Dixon Thomas and published by Elsevier. This book was released on 2018-11-23 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a basis to standardize and coordinate learning to practice, explaining basics and using self-learning strategies through online resources or other advanced texts. With an educational approach, it guides pharmacy students and pharmacists to learn quickly and apply. Clinical Pharmacy Education, Practice and Research provides an essential foundation for pharmacy students and pharmacists globally. Covers the core information needed for pharmacy practice courses Includes multiple case studies and practical situations with 70% focused on practical clinical pharmacology knowledge Designed for educational settings, but also useful as a refresher for advanced students and researchers
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 431 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, 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.
Download or read book Medical Writing in Drug Development written by Robert J Bonk and published by Routledge. This book was released on 2014-01-02 with total page 193 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide through the maze of the pharmaceutical research and development process, Medical Writing in Drug Development fills a gap in the libraries of technical writers, college instructors, and corporate professionals associated with the pharmaceutical process. As it discusses critical information, such as strategies and techniques pivotal to crafting documents for drug development, it also overviews drug research, document types, the roles of professional writers, and information technology. In no time at all, you will be creating persuasive technical documents, building complex facts into coherent messages, and contributing to the effective marketing of new products with promotional pieces that meet legal and ethical standards. Medical Writing in Drug Development helps medical writers and scientific, regulatory, and marketing professionals develop a working knowledge of the technical documents crucial to successful drug research. New and seasoned professional writers alike will benefit from the book's detailed discussions of: using abstracts, slides, and posters to present up-to-the-minute research how patient-education materials, health-economic assessments, and electronic journals provide ongoing challenges in medical writing a dossier approach that expedites regulatory submissions for international drug development structural constraints and rhetorical approaches toward regulatory documents presenting intricate information in scientifically unbiased, yet technically convincing language the effects of electronic publishing, computer graphics, and related technology on the practice of medical writing within pharmaceutical research Practical as a foundation text for undergraduate, graduate, and certificate programs in pharmaceutical or medical technical writing, Medical Writing in Drug Development will help you develop practical strategies for handling journal manuscripts, conference materials, and promotional pieces. No other text will clarify the main aspects of the pharmaceutical research and development process while offering you insight on the key issues dominating the healthcare arena.
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 Pharmaceutical Medicine and Translational Clinical Research written by Divya Vohora and published by Academic Press. This book was released on 2017-11-14 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery
Download or read book The Complete Guide to Medical Writing written by Mark C. Stuart and published by Pharmaceutical Press. This book was released on 2007 with total page 522 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'The Complete Guide to Medical Writing' is intended to consider all aspects of medical/scientific writing in one concise introductory text. It explains how to get published, how to write for a particular audience or in a particular media, what the publishing processes are and what the financial rewards might be.
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 Veterinary Pharmacovigilance written by Kevin Woodward and published by John Wiley & Sons. This book was released on 2009-11-24 with total page 776 pages. Available in PDF, EPUB and Kindle. Book excerpt: Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products is an in-depth examination of veterinary pharmacovigilance, looking at the scientific methodologies involved, the role of regulatory agencies and legislation, and the underpinning science. Edited by a renowned expert with over 20 years of experience in the field, it draws together the expertise of authors from around the world.
Download or read book Current Challenges in Pharmacovigilance written by World Health Organization and published by . This book was released on 2001-01-01 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
Download or read book An Introduction to Pharmacovigilance written by Patrick Waller and published by John Wiley & Sons. This book was released on 2017-02-14 with total page 192 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 To Err Is Human written by Institute of Medicine and published by National Academies Press. This book was released on 2000-03-01 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That's more than die from motor vehicle accidents, breast cancer, or AIDSâ€"three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems. To Err Is Human breaks the silence that has surrounded medical errors and their consequenceâ€"but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agendaâ€"with state and local implicationsâ€"for reducing medical errors and improving patient safety through the design of a safer health system. This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients' expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes. Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errorsâ€"which begs the question, "How can we learn from our mistakes?" Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care. To Err Is Human asserts that the problem is not bad people in health careâ€"it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocatesâ€"as well as patients themselves. First in a series of publications from the Quality of Health Care in America, a project initiated by the Institute of Medicine
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.
