Practical Aspects Of Signal Detection In Pharmacovigilance

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Practical Aspects of Signal Detection in Pharmacovigilance

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)

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Book Synopsis Practical Aspects of Signal Detection in Pharmacovigilance by : Council for International Organizations of Medical Sciences (CIOMS)

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.

Mann's Pharmacovigilance

Author : Elizabeth B. Andrews
Publisher : John Wiley & Sons
ISBN 13 : 0470671041
Total Pages : 878 pages
Book Rating : 4.4/5 (76 download)

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Book Synopsis Mann's Pharmacovigilance by : Elizabeth B. Andrews

Download or read book Mann's Pharmacovigilance written by Elizabeth B. Andrews and published by John Wiley & Sons. This book was released on 2014-06-23 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.

Registries for Evaluating Patient Outcomes

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)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

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.

Beyond Adverse Events

Author : Layo Emmanuel, MD
Publisher : Independently Published
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.3/5 (25 download)

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Book Synopsis Beyond Adverse Events by : Layo Emmanuel, MD

Download or read book Beyond Adverse Events written by Layo Emmanuel, MD and published by Independently Published. This book was released on 2024-04-25 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Beyond Adverse Events: A Deep Dive into Drug Safety and Signal Detection" offers a comprehensive exploration of the intricate world of pharmacovigilance, providing readers with a detailed understanding of the principles, methodologies, and practices essential for ensuring the safety and efficacy of pharmaceutical products. From laying the foundational knowledge to exploring cutting-edge advancements, this book aims to equip healthcare professionals, researchers, regulators, and students with the tools and insights necessary to navigate the complex terrain of drug safety with confidence and clarity. Structured into eight parts, each delving into specific aspects of drug safety and signal detection, "Beyond Adverse Events" serves as a comprehensive guide for anyone involved in the field of pharmacovigilance. Offering a thorough examination of drug safety and signal detection from foundational principles to cutting-edge advancements, the book empowers readers through practical examples, case studies, and insightful discussions. It aims to enable them to contribute effectively to the ongoing efforts to safeguard patient health and well-being in an ever-evolving healthcare landscape.

Current Challenges in Pharmacovigilance

Author : World Health Organization
Publisher :
ISBN 13 : 9789290360742
Total Pages : 381 pages
Book Rating : 4.3/5 (67 download)

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Book Synopsis Current Challenges in Pharmacovigilance by : World Health Organization

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.

Drug Safety in Developing Countries

Author : Yaser Mohammed Al-Worafi
Publisher : Academic Press
ISBN 13 : 0128204125
Total Pages : 656 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Drug Safety in Developing Countries by : Yaser Mohammed Al-Worafi

Download or read book Drug Safety in Developing Countries written by Yaser Mohammed Al-Worafi and published by Academic Press. This book was released on 2020-06-03 with total page 656 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues Describes current achievements of drug safety practice in developing countries Addresses the challenges of drug safety in developing countries Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety

An Introduction to Pharmacovigilance

Author : Patrick Waller
Publisher : John Wiley & Sons
ISBN 13 : 1119289785
Total Pages : 192 pages
Book Rating : 4.1/5 (192 download)

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Book Synopsis An Introduction to Pharmacovigilance by : Patrick Waller

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.

Principles of Safety Pharmacology

Author : Michael K. Pugsley
Publisher : Springer
ISBN 13 : 366246943X
Total Pages : 481 pages
Book Rating : 4.6/5 (624 download)

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Book Synopsis Principles of Safety Pharmacology by : Michael K. Pugsley

Download or read book Principles of Safety Pharmacology written by Michael K. Pugsley and published by Springer. This book was released on 2015-06-19 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.

Practical Approaches to Risk Minimisation for Medicinal Products

Author : World Health Organization
Publisher :
ISBN 13 : 9789290360841
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

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Book Synopsis Practical Approaches to Risk Minimisation for Medicinal Products by : World Health Organization

Download or read book Practical Approaches to Risk Minimisation for Medicinal Products written by World Health Organization and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large. Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of risk, "risk minimization" is used as an umbrella term for the prevention or mitigation of an undesirable outcome. Risk management always includes tools for "routine risk minimization" such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects. Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need "additional risk minimization," select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable. Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimization, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life.

The Importance of Pharmacovigilance

Author : World Health Organization
Publisher :
ISBN 13 : 9789241590150
Total Pages : 48 pages
Book Rating : 4.5/5 (91 download)

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Book Synopsis The Importance of Pharmacovigilance by : World Health Organization

Download or read book The Importance of Pharmacovigilance written by World Health Organization and published by . This book was released on 2002-01-01 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this document is to present the case for the importance of pharmacovigilance, to record its growth and potential as a significant discipline within medical science, and to describe its impact on patient welfare and public health.

Drug Safety Data

Author : Michael J. Klepper
Publisher : Jones & Bartlett Learning
ISBN 13 : 9780763769123
Total Pages : 312 pages
Book Rating : 4.7/5 (691 download)

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Book Synopsis Drug Safety Data by : Michael J. Klepper

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)

SMQs

Author : Cioms
Publisher :
ISBN 13 : 9789290360773
Total Pages : 96 pages
Book Rating : 4.3/5 (67 download)

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Book Synopsis SMQs by : Cioms

Download or read book SMQs written by Cioms and published by . This book was released on 2004-01-01 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this publication is to brief drug regulatory authorities, scientific institutions and pharmaceutical companies worldwide about the development, purpose and appropriate use of Standardized MedDRA Queries (SMQs) in drug surveillance. Two papers in this publication are to assist in the rational use of search queries in the identification and retrieval of potentially relevant individual case safety reports from a database and to harmonize presentation of search results. It also includes examples to illustrate the structure and content of end product.

Good Pharmacovigilance Practice Guide

Author :
Publisher :
ISBN 13 : 9780853698340
Total Pages : 0 pages
Book Rating : 4.6/5 (983 download)

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Book Synopsis Good Pharmacovigilance Practice Guide by :

Download or read book Good Pharmacovigilance Practice Guide written by and published by . This book was released on 2008-11 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to identifying hazards and preventing harm to patients.

Pharmacovigilance in the European Union

Author : Michael Kaeding
Publisher : Springer
ISBN 13 : 3658172762
Total Pages : 124 pages
Book Rating : 4.6/5 (581 download)

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Book Synopsis Pharmacovigilance in the European Union by : Michael Kaeding

Download or read book Pharmacovigilance in the European Union written by Michael Kaeding and published by Springer. This book was released on 2017-02-20 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is open access under a CC BY 4.0 license. The book presents the results of an in-depth comparative study assessing the implementation of the EU Pharmacovigilance Directive in six EU Member States. By going beyond legal transposition and instead focusing on practical implementation, this study aims to close a gap in EU compliance research. Based on qualitative interviews with relevant actors in Germany, Poland, Portugal, France, Finland and the UK, the authors identify perceived challenges and best-practices, issue recommendations, and thereby contribute to a better understanding of the factors that incentivize or impede the practical implementation of EU law at the national level.

Biologics, Biosimilars, and Biobetters

Author : Iqbal Ramzan
Publisher : John Wiley & Sons
ISBN 13 : 1119564654
Total Pages : 328 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Biologics, Biosimilars, and Biobetters by : Iqbal Ramzan

Download or read book Biologics, Biosimilars, and Biobetters written by Iqbal Ramzan and published by John Wiley & Sons. This book was released on 2021-02-03 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists

Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis

Author : World Health Organization
Publisher :
ISBN 13 : 9789241501583
Total Pages : 0 pages
Book Rating : 4.5/5 (15 download)

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Book Synopsis Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis by : World Health Organization

Download or read book Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis written by World Health Organization and published by . This book was released on 2015-04-20 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This 2011 update of Guidelines for the programmatic management of drug-resistant tuberculosis is intended as a tool for use by public health professionals working in response to the Sixty-second World Health Assembly's resolution on prevention and control of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis. Resolution WHA62.15, adopted in 2009, calls on Member States to develop a comprehensive framework for the management and care of patients with drug-resistant TB. The recommendations contained in these guidelines address the most topical questions concerning the programmatic management of drug-resistant TB: case-finding, multidrug resistance, treatment regimens, monitoring the response to treatment, and selecting models of care. The guidelines primarily target staff and medical practitioners working in TB treatment and control, and partners and organizations providing technical and financial support for care of drug-resistant TB in settings where resources are limited.

The Future of Drug Safety

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309133947
Total Pages : 346 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Future of Drug Safety by : Institute of Medicine

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.