Development And Rational Use Of Standardised Meddra Queries Smqs Retrieving Adverse Drug Reactions With Meddra Second Edition
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Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA – Second Edition
Author: Council for International Organizations of Medical Sciences (CIOMS)
language: en
Publisher: Council for International Organizations of Medical Sciences
Release Date: 2016-12-30
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.
CIOMS Cumulative Glossary with a Focus on Pharmacovigilance
Author: Council for International Organizations of Medical Sciences (CIOMS)
language: en
Publisher: Council for International Organizations of Medical Sciences
Release Date: 2024-10-31
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).
Introduction to MedDRA Labeling Grouping (MLG)
Author: Council for International Organizations of Medical Sciences (CIOMS)
language: en
Publisher: Council for International Organizations of Medical Sciences
Release Date: 2024-03-18
The Medical Dictionary for Regulatory Activities (MedDRA) is a terminology developed by the International Council for Harmonisation (ICH). While it is useful for precise coding of adverse events of medicines for data analysis, its high granularity can obscure the communication of adverse reactions in product labeling for healthcare practitioners. Many sponsors and regulators have therefore begun to develop their own approaches to clustering similar adverse reaction terms in medical product prescribing information on a product-by-product basis. However, there are no agreed-upon conventions that describe which adverse reaction terms may be appropriate to group together. To improve safety communication to patients and healthcare providers, there is an urgent need for a harmonized international approach to the creation and use of groups of MedDRA terms, or “MedDRA Labeling Groupings (MLGs)”, in medical product prescribing information. The use of the consensus recommendations proposed in this report would be voluntary and applied to product labels in a manner that is consistent with existing regulatory frameworks.