This blog highlights:
- The definition and role of CIOMS (Council for International Organizations of Medical Sciences).
- CIOMS’ contributions to pharmacovigilance and public health.
Table of Contents:
- Introduction to CIOMS
- CIOMS in Pharmacovigilance
- Responsibility of CIOMS
- How does CIOMS contribute to public health?
- Key takeaways
- Conclusion
- Reference
- FAQ
Introduction to CIOMS:
The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949. Headquartered in Geneva, Switzerland.
CIOMS represents a substantial proportion of the biomedical scientific community through its member organizations, which include many of the biomedical disciplines, national academies of sciences and medical research councils.
Its mission is to advance public health through guidance on health research and policy including ethics, medical product development and safety. CIOMS is in official relations with WHO and is an associate partner of UNESCO.
CIOMS in pharmacovigilance
In 1986, CIOMS set up its first Working Group on pharmacovigilance, a Working Group on International Reporting of Adverse Drug Reactions to explore means of coordinating and standardizing international adverse drug reporting by pharmaceutical manufacturers to regulatory authorities.
In pharmacovigilance, CIOMS refers to the Council for International Organizations of Medical Sciences. CIOMS has produced a number of guidance documents on pharmacovigilance, including the CIOMS Cumulative Pharmacovigilance Glossary.
This glossary provides definitions for terms used in pharmacovigilance, and is a valuable resource for healthcare professionals and researchers.
Would you like to check the CIOMS form to the ICH-E2B format. Check this out here.
“CIOMS transcends being a mere intermediary process; it evolves into an entity that embodies more than just assistance.”
Aim of CIOMS
CIOMS focuses on the following key areas:
- Ethical Guidelines
- Drug Safety
- Medical Product Development
- Health Data Sharing
- Education and Capacity Building
- Monitoring adverse events
- Prepare and Maintain reporting forms
1. Ethical Guidelines:
CIOMS develops and updates ethical guidelines for medical research involving human subjects. These guidelines aim to ensure that research involving human participants is conducted with the utmost respect for their rights, safety, and well-being.
2. Drug Development & Safety:
CIOMS contributes to aligning international systems and terminologies for the surveillance of medicinal products and vaccines, fostering agreement among stakeholders.
3. Medical Product Development:
CIOMS facilitates the development of guidelines and best practices for the evaluation and regulation of medical products, including vaccines, drugs, and medical devices.
4. Health Data Sharing:
CIOMS encourages the responsible sharing of health-related data to advance medical research while respecting individual privacy and data protection.
5. Education and Capacity Building:
CIOMS supports educational initiatives and capacity-building activities to strengthen the ethical conduct of research and enhance safety standards in medical sciences.
6. Monitoring adverse events:
CIOMS plays a crucial role in overseeing and advancing drug safety by creating guidelines and recommendations for identifying and handling adverse drug reactions.
7. Prepare and Maintain reporting forms:
CIOMS cover the areas include international reporting of adverse drug reactions (CIOMS I reporting form), management of safety data from clinical trials, periodic drug safety updates in the pre-and post-approval phases, core clinical safety information on drugs in development and etc…
How does CIOMS contribute to public health?
By producing guidance documents on:
- Ethics
- Clinical research
- Pharmacovigilance
- Medical product registration
CIOMS helps,
- To ensure health research is conducted ethically and safely
- To organises workshops and symposia on a variety of health topics
- Helps to raise awareness of important public health issues
Key takeaways
CIOMS was initially founded in 1949 through a collaboration between WHO and UNESCO.
The initial involvement of CIOMS in pharmacovigilance dates back to 1986 with its establishment and the publication of its first report.
CIOMS extends beyond merely providing forms; it functions as a distinct organization.
As a non-governmental and non-profit entity, CIOMS operates with these guiding principles.
CIOMS Publication in Pharmacovigilance
CIOMS Working Group reports on pharmacovigilance topics:
- Drug-induced liver injury (DILI), 2020
- CIOMS Guide to Vaccine Safety Communication, 2017
- CIOMS Guide to Active Vaccine Safety Surveillance, 2016
- and many more
Conclusion
Some of us may view CIOMS simply as another set of paper or electronic forms used in pharmacovigilance, similar to other documentation. However, through this write-up, you have likely discovered new insights and different side into the role and contributions of CIOMS within pharmacovigilance.
While this overview may have overlooked certain unique details, it has presented previously unexplored information.
Your feedback on any missed points or recommendations for improvement are greatly appreciated.
References:
- CIOMS
- CIOMS Form
- Bird SM (2014). The 1959 meeting in Vienna on controlled clinical trials – a methodological landmark.
- CIOMS Cumulative Pharmacovigilance Glossary
- CIOMS in Pharmacovigilance
FAQ:
What is CIOMS?
CIOMS in Pharmacovigilance
Focus of CIOMS in Pharmacovigilance
2. Drug safety
3. Medical product development
4. Health data sharing
5. Education and capacity building
Contribution of CIOMS to Public Health
1. Ethics
2. Clinical Research
3. Pharmacovigilance
4. Medical Product Registration
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