Version 7 of the CIOMS Glossary of ICH terms and definitions is now freely available here. It can also be accessed from the ICH webpage here.
The Chinese translation of the 2024 report Real-world data and real-world evidence in regulatory decision making is now available here
The 75th Anniversary Edition of the CIOMS cumulative glossary, with a focus on pharmacovigilance can be freely downloaded here. Exceptionally, it is also made available as a limited print edition.
This report is available here and describes the potential use of real-world evidence (RWE) for decision making; real-world data (RWD) and data sources; key scientific considerations in the generation of RWE; and ethical and governance issues in using RWD.
Click here for the draft report and comment form. Deadline: Friday 7 June 2024
This report is available here giving a harmonized international approach to the creation and use of groups of MedDRA terms, or “MedDRA Labeling Groupings (MLGs)”, in medical product prescribing information.
This publication is available in Polish here. We gratefully acknowledge Jagiellonian University Press for its generous support to produce this translation.
The CIOMS cumulative glossary with a focus on pharmacovigilance (version 2.1) is now freely available in Korean. ![[External link]](https://cioms.ch/wp-content/uploads/2022/08/custom_ExternalLink.png){kind=small}
We gratefully acknowledge SELTA SQUARE for its generous support to produce this translation.
Version 5 of the CIOMS Glossary of ICH terms and definitions is now freely available here. It can also be accessed from the ICH webpage here.
The aim of this report is to help research institutions better fulfil their responsibilities in terms of protecting human research participants and their communities, involving and engaging them in the research processes, and guaranteeing the pertinence and quality of research while making the best use of available resources.
The CIOMS Working Group XI report on Patient involvement in the development, regulation and safe use of medicines is now available in Japanese from the website of the journal Rinsho Hyoka (Clinical evaluation) via this link. The final print version, with minor corrections and format changes, will replace the pre-print version in due course.
The CIOMS cumulative glossary is an organized collection of the terms and definitions included in published CIOMS Working Group reports, with a focus on pharmacovigilance. Find Version 2.1 here.
The meeting report is now available from the CIOMS / GENDRO joint meeting held on 2 February 2023.
The draft report of the CIOMS Working Group on Good Governance Practice for Research Institutions is now available for public comments here
The Chinese translation of the CIOMS Working Group VI report, 'Management of Safety Information from Clinical Trials', is now available here.
This glossary combines the terms and definitions included in the publicly available guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Free download at: https://doi.org/10.56759/eftb6868
The CIOMS cumulative glossary is an organized collection of the terms and definitions included in published CIOMS Working Group reports, with a focus on pharmacovigilance. Find Version 2.0 here: https://doi.org/10.56759/ocef1297
This report describes the importance of systematically involving patients throughout a medicine’s life – from its pre-clinical and clinical development, through the regulatory process to ongoing monitoring and safe use in everyday healthcare. More
CIOMS is pleased to announce that in cooperation with CIOMS Uppsala Monitoring Centre (UMC), an e-learning course based on the 2020 CIOMS Working Group report on Drug Induced liver injury (DILI) is now available.
Report of CIOMS Working Group XI: Patient involvement in the development, regulation and safe use of medicines. The draft report and the comment form are available here. Closing date for comments: 11 April 2022
The aim of this report is to provide balanced arguments to promote scientifically sound, good quality clinical research in low-resource settings. It provides a comprehensive set of recommendations directed to all major stakeholder groups. The report can be freely downloaded here. Printed copies will also be available.
This version newly includes terms from additional CIOMS Working Group reports, including vaccine-related ones. Find the CIOMS cumulative pharmacovigilance glossary (Version 1.1) here.
Find the CIOMS cumulative pharmacovigilance glossary (Version 1.0) here.
Click here to access the draft document and the form to use for comments.
The 2020 CIOMS award of US-$ 1500 for the best scientific article published by a medical student goes to Ronald Olum from Makerere University in Uganda. Read more here.
Read the Statement of Council for International Organizations of Medical Sciences (CIOMS) International Expert Working Group XI
International Conference on Pharmacovigilance and Protection for Research Participants (ECD2020) & webinar on CIOMS Consensus Report on Drug-Induced Liver Injury (DILI): 20 November 2020
Read the recent article about CIOMS published in Drug Safety.
The CIOMS 2020 annual award of $1500 US for the best scientific article published in the areas of pharmacovigilance and research ethics is seeking applications up to 30 November 2020. More information here.
The PDF versions of these publications are now free of charge to download: CIOMS Guide to Active Vaccine Safety Surveillance and CIOMS Guide to Vaccine Safety Communication
UPDATE: The webinar held on 20 July 2020 on the recently published CIOMS Consensus Report on Drug-Induced Liver Injury (DILI) is now available online:
The CIOMS consensus report on Drug-induced liver injury (DILI) was produced by leading DILI experts from drug regulation, industry and research. It provides a critical framework and essential set of tools to detect, diagnose and manage DILI during drug development and in the post-marketing setting. The PDF can be freely downloaded here. Printed copies will also be available.
Statement from the CIOMS International Expert Working Group on Benefit-Risk Balance for Medicinal Products
The 2019 CIOMS award of US-$ 1500 for the best scientific article published by a medical student goes to Mieke Foster from Deakin University in Australia. In her paper, Mieke is proposing a simpler and safer approach to calculating medication doses for children with cardiac arrest. Read more here. CIOMS is continuing to receive applications for the 2019 annual award.
Click here to access the free online training module on the 2016 International Ethical Guidelines for Health-related Research Involving Humans. The course includes example case studies and a certificate.
CIOMS supports civil society organization, CHAIN, in Uganda, member of IAPO, with workshop on “Opportunities and Challenges of Patient Involvement in Drug Development and Safe Use of Medicines in Resource Limited Settings”. More
We are delighted to announce that Ms. Connie Rees from the University Medical Center Utrecht, the Netherlands, received the CIOMS annual award 2018 of US$ 1500 for the best scientific article published by a medical student in the areas of pharmacovigilance and/or research ethics. More
This 2018 publication is now available free of charge in PDF format (no more hardcopies left). Click here to access the bookshop.
The International Alliance of Patients’ Organizations (IAPO) is part of the CIOMS Working Group on Patient Involvement in the Development and Safe Use of Medicines.
The Portuguese translation of the 2016 CIOMS International Ethical Guidelines for Health-related Research Involving Humans is now available in CIOMS online bookstore
The newly released Oxford Statement is calling for action to ensure that everyone, everywhere has access to safe, quality medicines. Read the statement here. More information is found on the Meds We Can Trust website.
New CIOMS Working Group on Patient Involvement on Development and Safe Use of Medicines is launched in Geneva on 20 April 2018. Read more.
CIOMS is pleased to announce the release of a new publication: CIOMS Guide to Vaccine Safety Communication (2018) which is now available in our bookshop.
This CIOMS presentation was given in Kuala Lumpur at the occasion of the 6th WHO Global Vaccine Safety Initiative meeting which took place in Kuala Lumpur in October 2017.
The Spanish translation of International ethical guidelines for health-related research involving humans, 2016 is now available for free download from our bookshop.
A new CIOMS Working Group on Clinical Research in Resource-Limited Settings was launched on 20 November 2017 in Geneva. Read more.
This 2005 publication, previously out of stock, is now available in PDF format in the CIOMS bookshop.
(French translation of International ethical guidelines for health-related research involving humans, 2016) . Now available in our bookshop.
Comments are invited on the new draft CIOMS Guide to Vaccine Safety Communication.
Four earlier CIOMS publications in Pharmacovigilance including Guidelines for preparing core clinical safety information on drugs, and Monitoring and Assessment of Adverse Drug Effects - previously out of print - are now available in our bookshop.
CIOMS is pleased to introduce the new E-shop for CIOMS publications. CIOMS publications can now only be purchased online with a credit card at the following link: cioms.ch/shop. If you have any suggestions how to improve it further or in case you experience problems with the new E-shop, please send an email to info@cioms.ch and we will reply to you as soon as we can.
Two earlier CIOMS publications on Guidelines for preparing core clinical safety information on drugs that were out of print are now available in our bookshop.
CIOMS is pleased to announce the release of four new publications from our Working Groups 1. Evidence Synthesis and Meta-Analysis for Drug Safety, Report of CIOMS Working Group X Read more 2. Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA – Second Edition Read more 3. International ethical guidelines for health-related research involving humans. Read more 4. CIOMS Guide to Active Vaccine Safety Surveillance Read more
The electronic version of CIOMS Working Group VIII is now available in the new e-shop.
New CIOMS Working Group on Drug Induced Liver Injury is launched in Geneva on 27 April 2017. Read more.
The Council for International Organizations of Medical Sciences (CIOMS) addresses new challenges of protecting humans participating in health-related research. On 6 December 2016 the text of the new CIOMS International Ethical Guidelines for Health-related Research involving Humans was web posted. We are also happy to note that the Journal of American Medical Association (JAMA) published an article on 6 December 2016 describing these important for protecting humans participating in health-research guidelines. The final text was approved by the CIOMS Executive Committee during the XXII General Assembly of CIOMS on 29 November 2016. The publication in PDF format is available for free download below. Printed copies will be available for purchase from 1 February 2017.