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Practical Approaches To Risk Minimisation For Medicinal Products

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Practical Approaches To Risk Minimisation For Medicinal Products

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Author : Council for International Organizations of Medical Sciences (CIOMS)
language : en
Publisher: Council for International Organizations of Medical Sciences
Release Date : 2014-12-31

Practical Approaches To Risk Minimisation For Medicinal Products written by Council for International Organizations of Medical Sciences (CIOMS) and has been published by Council for International Organizations of Medical Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-12-31 with Medical categories.

Medical science continues to bridge new frontiers with an ever-widening array of medicinal products to treat illnesses and health conditions. No medicine is devoid of risk, however, and for that reason, it becomes paramount to appropriately manage all kinds of risks, from the very minor ones to those with serious adverse effects, with the objective being a positive balance of benefits to risks. 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.

Therapeutic Risk Management Of Medicines

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Author : Stephen J. Mayall
language : en
Publisher: Elsevier
Release Date : 2014-04-16

Therapeutic Risk Management Of Medicines written by Stephen J. Mayall and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-04-16 with Medical categories.

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

Cioms Cumulative Glossary With A Focus On Pharmacovigilance

Cioms Cumulative Glossary With A Focus On Pharmacovigilance written by Council for International Organizations of Medical Sciences (CIOMS) and has been published by Council for International Organizations of Medical Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-10-31 with Science categories.

person My Account Log Out PUBLICATIONS Home Products Recently published CIOMS Cumulative Glossary with a Focus on Pharmacovigilance - 75th Anniversary Edition CIOMS Cumulative Glossary with a Focus on Pharmacovigilance – 75th Anniversary Edition Reflecting the work of CIOMS over the past decades, this glossary is an organized collection of the terms and definitions included in published CIOMS Working Group reports, with a focus on pharmacovigilance. It includes links to the reports and, where applicable, provides references to the sources from which the definitions were adopted or modified. The 75th Anniversary Edition covers the terms included in fifteen different CIOMS reports published between 1992 and 2024. It does not cover CIOMS r Read more... In Stock isbn: 978-929036108-4 Year of publication: 2024 Number of pages: 143 SKU: 67000 https://doi.org/10.56759/ocef1297 Previous versions: CIOMS Cumulative glossaries (archived) Quick links: Book Description Download free PDF book Free Hardcopy, postage will be added 0 00 CHF Amount: CIOMS Cumulative Glossary with a Focus on Pharmacovigilance - 75th Anniversary Edition quantity Add to cart Reflecting the work of CIOMS over the past decades, this glossary is an organized collection of the terms and definitions included in published CIOMS Working Group reports, with a focus on pharmacovigilance. It includes links to the reports and, where applicable, provides references to the sources from which the definitions were adopted or modified. The 75th Anniversary Edition covers the terms included in fifteen different CIOMS reports published between 1992 and 2024. It does not cover CIOMS reports on the subjects search ethics, pharmacogenetics, clinical pharmacology, publications on the development and use of standardised MedDRA® queries (SMQs), or publications resulting from CIOMS Roundtable Discussions (1967–1997).

Severe Cutaneous Adverse Reactions Scar A Consensus By A Cioms Working Group

Severe Cutaneous Adverse Reactions Scar A Consensus By A Cioms Working Group written by Council for International Organizations of Medical Sciences (CIOMS) and has been published by Council for International Organizations of Medical Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-04-29 with Medical categories.

In clinical practice, concern is growing about the burden of severe cutaneous adverse reactions (SCAR) in relation to novel biologics, as well as the increasing cost of their diagnosis and management. The skin is among the parts of the body most commonly affected by adverse drug reactions (ADRs). Cutaneous ADRs affect 2% to 3% of all hospitalized patients and have a wide spectrum of clinical manifestations, are caused by various medicinal products, and result from different pathophysiologic mechanisms. Their diagnosis and management are therefore challenging. Approximately 0.1% to 1% of patients with medicinal product eruptions have serious ADRs which can lead to disabling sequelae and in some cases, fatalities. SCAR include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and generalized bullous fixed drug eruptions (GBFDE). So although rare, SCAR are a significant health challenge, and hinder the safe and effective use of medicines. They pose substantial hurdles to drug developers, medicines regulators and health professionals. This consensus report provides unique insights and the latest thinking from renowned experts on this important topic. https://doi.org/10.56759/lrty1600

Evidence Synthesis And Meta Analysis

Evidence Synthesis And Meta Analysis written by Council for International Organizations of Medical Sciences (CIOMS) and has been published by Council for International Organizations of Medical Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-12-30 with Medical categories.

At any point in the drug development process, systematic reviews and meta-analysis can provide important information to guide the future path of the development programme and any actions that might be needed in the post-marketing setting. This report gives the rationale for why and when a meta-analysis should be considered, all in the context of regulatory decision-making, and the tasks, data collection, and analyses that need to be carried out to inform those decisions. There is increasing demand by decision-makers in health care, the biopharmaceutical industry, and society at large to have access to the best available evidence on benefits and risks of medicinal products. The best strategy will take an overview of all the evidence and where it is possible and sensible, combine the evidence and summarize the results. For efficacy, the outcomes generally use the same or very similar predefined events for each of the trials to be included. Most regulatory guidance and many Cochrane Collaboration reviews have usually given more attention to assessment of benefits, while issues around combining evidence on harms have not been as well-covered. However, the (inevitably) unplanned nature of the data on safety makes the process more difficult. Combining evidence on adverse events (AEs), where these were not the focus of the original studies, is more challenging than combining evidence on pre-specified benefits. This focus on AEs represents the main contribution of the current CIOMS X report. The goal of the CIOMS X report is to provide principles on appropriate application of meta-analysis in assessing safety of pharmaceutical products to inform regulatory decision-making. This report is about meta-analysis in this narrow area, but the present report should also provide conceptually helpful points to consider for a wider range of applications, such as vaccines, medical devices, veterinary medicines or even products that are combinations of medicinal products and medical devices. Although some of the content of this report describes highly technical statistical concepts and methods (in particular Chapter 4), the ambition of the working group has been to make it comprehensible to non-statisticians for its use in clinical epidemiology and regulatory science. To that end, Chapters 3 and 4, which contain the main technical statistical aspects of the appropriate design, analysis and reporting of a meta-analysis of safety data are followed by Chapter 5 with a thought process for evaluating the findings of a meta-analysis and how to communicate these.

An Introduction To Pharmacovigilance

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Author : Patrick Waller
language : en
Publisher: John Wiley & Sons
Release Date : 2017-02-14

An Introduction To Pharmacovigilance written by Patrick Waller and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-14 with Medical categories.

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.

Drug Induced Liver Injury

Drug Induced Liver Injury written by Council for International Organizations of Medical Sciences (CIOMS) and has been published by Council for International Organizations of Medical Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-06-15 with Medical categories.

Drug-induced liver injury (DILI) is a growing challenge because of the ever- increasing number of drugs used in medical care. DILI is rare but can be serious and is largely unpredictable. It is an important cause of mortality and liver transplantation, and a leading cause of attrition in drug development. Progress is under way in identifying genetic risk factors, exploring new mechanistic concepts of the complex underlying interactions, and developing new biomarkers that can predict or diagnose DILI. The pharmaceutical industry has a key role in advancing these initiatives, and prospective DILI registries must adopt standard procedures for biological sample collection and storing. There is a strong need for standard guidelines to support these efforts.The consensus report of the CIOMS DILI Working Group aims to provide a critical framework and essential set of tools to detect, diagnose and manage DILI during drug development and in the post-marketing setting. The report is intended for clinical and basic pharmaceutical industry investigators who capture, analyze and communicate liver safety data in drug development. It is also intended for regulatory scientists and expert consultants who comprehensively evaluate new products and emerging biomarkers for their association with DILI risk, and for health care professionals who monitor and manage patients treated with potentially hepatotoxic drugs in clinical practice. Corrigendum: On page 138, under ‘Number needed to harm (NNH), the last sentence should read: “Thus, on average, 25 people would need to be treated for one year for one person to experience a harmful event (1 in 25 people =4%).” The downloadable file was corrected on 6 September 2024.

Pharmacovigilance

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Author : Dr. Agnimitra Dinda
language : en
Publisher: Thakur Publication Private Limited
Release Date : 2021-03-10

Pharmacovigilance written by Dr. Agnimitra Dinda and has been published by Thakur Publication Private Limited this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-03-10 with Medical categories.

Purchase the e-Book version of ‘Pharmacovigilance’ for B.Pharm 8th Semester, meticulously aligned with the PCI Syllabus. Published by Thakur Publication, this digital edition offers a comprehensive exploration of advanced instrumentation techniques at your fingertips. Upgrade your learning experience with the convenience and portability of an e-Book. Dive into the world of cutting-edge pharmaceutical instrumentation with ease. Get your copy today and embark on a journey of enhanced understanding.

Development And Rational Use Of Standardised Meddra Queries Smqs Retrieving Adverse Drug Reactions With Meddra Second Edition

Development And Rational Use Of Standardised Meddra Queries Smqs Retrieving Adverse Drug Reactions With Meddra Second Edition written by Council for International Organizations of Medical Sciences (CIOMS) and has been published by Council for International Organizations of Medical Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-12-30 with Medical categories.

MedDRA® is a valuable health informatics tool used to code, report, analyse and communicate regulatory information for medicinal products for human use. This includes regulated safety data. To retrieve data on medical concepts from complex MedDRA-coded databases using consistent methodology, Standardised MedDRA Queries (SMQs) have been developed over the past decade by senior scientists from many countries under the guidance of the Council for International Organizations of Medical Sciences (CIOMS) This CIOMS activity has been conducted in conjunction with the ICH MedDRA Management Board, the MedDRA Maintenance and Support Services Organization (MSSO), the Japanese MedDRA Maintenance Organization (JMO) and other stakeholders. SMQs represent a standardised approach to establishing a baseline for the identification of Individual Case Safety Reports (ICSRs) that may represent defined medical conditions that have the potential to impact benefit-risk assessments. Examples of the valuable use of SMQs, such as monitoring of potential safety risks and analysis of aggregate data, are included in this report. The included examples are meant to illustrate the use of queries in systematic analyses (e.g. meta‐analysis), interventional clinical trials, signal detection, safety signal assessment and other database searches. In clinical trials, SMQs can be used to compare investigational medical products to comparators, including placebo, and to other molecules in the same class or with a similar mechanism of action. SMQs can also serve as useful tools in vaccine vigilance and technovigilance (medical devices). A critical design feature of each SMQ is consideration of the practical aspects required for implementation with real ICSR data. Prior to publication by the MSSO and JMO, the CIOMS working groups have extensively tested each SMQ for fit-for-purpose functionality with real world data in both health authority and company product databases. The descriptive material that accompanies each SMQ outlines benefits and applications of the specific SMQ, as well as identified limitations. The aim of this publication is to inform regulatory authorities, scientific institutions, pharmaceutical companies and other organizations or individuals involved in pharmaceutical and other medicinal product development, about the purpose and appropriate use of SMQs in safety surveillance activities. MedDRA® is a product of the International Conference for Harmonisation (ICH) owned by the International Federation of Pharmaceutical Manufacturers Associations as trustee for ICH.

Benefit Risk Assessment Methods In Medical Product Development

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Author : Qi Jiang
language : en
Publisher: CRC Press
Release Date : 2017-12-19

Benefit Risk Assessment Methods In Medical Product Development written by Qi Jiang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-12-19 with Mathematics categories.

Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations.

Practical Approaches To Risk Minimisation For Medicinal Products

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