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Author : Deepa Arora
Publisher : Pharmapublisher
ISBN 13 : 8192335402
Total Pages : 170 pages
Book Rating : 4.1/5 (923 download)
Download or read book Pharmacovigilance- An Industry Perspective written by Deepa Arora and published by Pharmapublisher. This book was released on with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : Cioms
ISBN 13 : 9789290360827
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)
Download or read book Practical Aspects of Signal Detection in Pharmacovigilance written by Council for International Organizations of Medical Sciences (CIOMS) and published by Cioms. This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.
Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 396 pages
Book Rating : 4.5/5 (876 download)
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.
Author : Thao Doan
Publisher : Elsevier Health Sciences
ISBN 13 : 032358117X
Total Pages : 228 pages
Book Rating : 4.3/5 (235 download)
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.
Author : Valentina E. Balas
Publisher : Academic Press
ISBN 13 : 0128213264
Total Pages : 382 pages
Book Rating : 4.1/5 (282 download)
Download or read book An Industrial IoT Approach for Pharmaceutical Industry Growth written by Valentina E. Balas and published by Academic Press. This book was released on 2020-05-29 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: An Industrial IoT Approach for Pharmaceutical Industry Growth, Volume Two uses an innovative approach to explore how the Internet of Things (IoT) and big data can improve approaches and make discoveries. Rapid growth of the IoT has encouraged many companies in the manufacturing sector to make use of this technology to unlock its potential. Using clear language and real-world case studies, this book discusses systems level from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing. The wide variety in topics presented offers multiple perspectives on how to integrate the Internet of Things into pharmaceutical manufacturing. This book represents a useful resource for researchers in pharmaceutical sciences, information and communication technologies, and those who specialize in healthcare and pharmacovigilance. Emphasizes efficiency in pharmaceutical manufacturing through an IoT/Big Data approach? Explores cutting-edge technologies through sensor enabled environments in the pharmaceutical industry? Discusses system levels from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing
Author : Brian L. Strom
Publisher : John Wiley & Sons
ISBN 13 : 1119413419
Total Pages : 1220 pages
Book Rating : 4.1/5 (194 download)
Download or read book Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2019-12-16 with total page 1220 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.
Author : Stephen J. Mayall
Publisher : Elsevier
ISBN 13 : 1908818271
Total Pages : 435 pages
Book Rating : 4.9/5 (88 download)
Download or read book Therapeutic Risk Management of Medicines written by Stephen J. Mayall and published by Elsevier. This book was released on 2014-04-16 with total page 435 pages. Available in PDF, EPUB and Kindle. Book excerpt: Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders. A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US. This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts. An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicines A number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan) A comprehensive guide for performing risk management more effectively throughout a product’s life-cycle
Author : Neil Pearce
Publisher : Auckland University Press
ISBN 13 : 1775580113
Total Pages : 312 pages
Book Rating : 4.7/5 (755 download)
Download or read book Adverse Reactions written by Neil Pearce and published by Auckland University Press. This book was released on 2013-11-01 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recounting the fenoterol epidemic—a major medical controversy that took place more than 15 years ago—this narrative explores the involvement of the asthma drug that caused numerous asthma deaths. Although the epidemic occurred in New Zealand, its shocking discoveries and subsequent consequences attracted worldwide attention in medical journals and conferences. Neil Pearce, the researcher who discovered that fenoteral was the cause of the epidemic, tells this personal story while raising concerns about drug safety internationally and analyzing the battle between money and science in medical research.
Author : Lars Schweizer
Publisher : Saint Philip Street Press
ISBN 13 : 9781013277788
Total Pages : 0 pages
Book Rating : 4.2/5 (777 download)
Download or read book Advances in Pharma Business Management and Research written by Lars Schweizer and published by Saint Philip Street Press. This book was released on 2020-10-09 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book presents a unique collection of practical examples from the field of pharma business management and research. It covers a wide range of topics such as: 'Brexit and its Impact on pharmaceutical Law - Implications for Global Pharma Companies', 'Implementation of Measures and Sustainable Actions to Improve Employee's Engagement', 'Global Medical Clinical and Regulatory Affairs (GMCRA)', and 'A Quality Management System for R&D Project and Portfolio Management in a Pharmaceutical Company'. The chapters are summaries of master's theses by "high potential" Pharma MBA students from the Goethe Business School, Frankfurt/Main, Germany, with 8-10 years of work experience and are based on scientific know-how and real-world experience. The authors applied their interdisciplinary knowledge gained in 22 months of studies in the MBA program to selected practical themes drawn from their daily business. This work was published by Saint Philip Street Press pursuant to a Creative Commons license permitting commercial use. All rights not granted by the work's license are retained by the author or authors.
Author : John P. Griffin
Publisher : John Wiley & Sons
ISBN 13 : 047098726X
Total Pages : 883 pages
Book Rating : 4.4/5 (79 download)
Download or read book The Textbook of Pharmaceutical Medicine written by John P. Griffin and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 883 pages. Available in PDF, EPUB and Kindle. Book excerpt: New edition of succesful standard reference book for thepharmaceutical industry and pharmaceutical physicians! The Textbook of Pharmaceutical Medicine is the coursebookfor the Diploma in Pharmaceutical Medicine, and is used as astandard reference throughout the pharmaceutical industry. The newedition includes greater coverage of good clinical practice, acompletely revised statistics chapter, and more on safety. Coversthe course information for the Diploma in PharmaceuticalMedicine Fully updated, with new authors Greater coverage of good clinical practice and safety New chapters on regulation of medical devices in Europe andregulation of therapeutic products in Australia
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309133947
Total Pages : 346 pages
Book Rating : 4.3/5 (91 download)
Download or read book The Future of Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2007-02-27 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Author : Congressional Budget Office
Publisher : Lulu.com
ISBN 13 : 1304121445
Total Pages : 65 pages
Book Rating : 4.3/5 (41 download)
Download or read book Research and Development in the Pharmaceutical Industry (A CBO Study) written by Congressional Budget Office and published by Lulu.com. This book was released on 2013-06-09 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309498635
Total Pages : 169 pages
Book Rating : 4.3/5 (94 download)
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Author : Michael J. Klepper
Publisher : Jones & Bartlett Learning
ISBN 13 : 9780763769123
Total Pages : 312 pages
Book Rating : 4.7/5 (691 download)
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)
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)
Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309494885
Total Pages : 127 pages
Book Rating : 4.3/5 (94 download)
Download or read book Virtual Clinical Trials written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-11-16 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.
Author : Maria Teresa Herdeiro
Publisher : BoD – Books on Demand
ISBN 13 : 1839685964
Total Pages : 202 pages
Book Rating : 4.8/5 (396 download)
Download or read book New Insights into the Future of Pharmacoepidemiology and Drug Safety written by Maria Teresa Herdeiro and published by BoD – Books on Demand. This book was released on 2021-10-13 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the last decade, pharmacoepidemiology has emerged as an important field to study the use/effects of drugs in large populations in real life, allowing for improved benefits and effectiveness of drugs as well as a decline in drug-related risks. The correct assessment, reporting, monitoring, and prevention of adverse events in drugs’ development, as well as therapy and post-market surveillance, is essential to improve clinical therapies and health outcomes. This book provides a comprehensive and unique overview of the relevance, new insights, and recent findings of pharmacoepidemiology and drug safety in public health.
