This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.

1. CIOMS
Sanjay Yadav
M.Pharm (Pharmacology)

2. What is CIOMS?
Council for
International
Organizations of
Medical
Sciences
A. International
B. Non-Governmental
C. Non-Profit
 Established jointly by WHO and associate partners of UNESCO in
1949 in a meeting at Brussels.
 CIOMS is situated in Geneva, Switzerland.

3.  It represents a substantial proportion of the biomedical scientific community through its
biomedical scientific community through its member organizations, which include many of
the biomedical disciplines, national academies of sciences and medical research councils.
To advance public health through guidance on health research
including ethics, medical product development and safety.
 Forum for discussion and neutral platform to elaborate new ideas in medical product
development, Pharmacovigilance and research ethics (bioethics)

5. HISTORY
 1948 – UNESCO consulted the WHO, thus an agreement between WHO and UNESCO was made for the
establishment of a permanent council for coordination of International Medical Congresses.
 1949 - Council formally constituted in Brussels by WHO and UNESCO.
 1952 - Present name CIOMS adopted.
 1959 - Vienna meeting on controlled clinical trials.
To discuss the principles, organizations and scope of controlled clinical trials which must be carried out if new
methods or preparations used for the treatment of disease are to be accurately assessed clinically.
 1977 - Launch of Ethics of Research involving humans.
 1982 - Adoption by UN of CIOMS Medical Ethics for prisoners.
 1993 - Start of CIOMS focus on pharmacovigilance and reporting adverse drug reactions.
 2016 - New CIOMS Ethical Guidelines for Health-related research involving humans.

6. Interesting Facts
about CIOMS
The general assembly
of UN adopted CIOMS
principles of medical
Ethics related to
prisoners in 1983.
In 1986- The very 1st
CIOMS working
group report 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.
• Its agenda was limited to
post-marketing reporting of
adverse drug reactions
occurring in one country
and which the
pharmaceutical industry
should report to regulatory
authorities in other
countries where the drug is
also marketed.
The world health
assembly adopted
CIOMS Ethical
criteria for medicinal
drug promotions in
1994.
The longest running
CIOMS Working
Group- since- 2002-
is dedicated to
standardized
MedDRA Queries
(SMQs)
CIOMS
pharmacovigilance
guidelines have
been the basis for
respective ICH
guidelines.

7. CIOMS
collaborations
WHO
UNESCO
ICH
IFMSA
IFPMA
ISOP
IUPHAR
MedDRA
WMA

8. Contact Details
Phone: +41 (0) 22 791 6497 - Due to the COVID-19 situation we
are often working from home. Please contact us by e-mail.
Email: info@cioms.ch

9. Organization
Bioethics
Since 1967; CIOMS Round Table
Conference “Biomedical Science and
the dilemma of Human
Experimentation”)
Issuance of significant guidelines;
latest revision 2016
Focus on “low and middle income
countries”; translation into various
languages
Pharmacovigilan
ce
1986 first PV Working Group, 13
more working group reports until
today
Several ICH Guidelines are based
on results of CIOMS Working
Groups
Product
Development
Trends and Prospects in
Drug Research and
Development.
Proceedings of the 11th
CIOMS Round Table
Conference, Geneva,
Switzerland, 8-9 December
1977. Ed. Z. Bankowski, J.F.
Dunne, Published by scrip
World Pharmaceutical News
London, 1978.

10. Pharmacovigilance: Working Groups
Working Group Period (some examples) Report/Year
CIOMS I - International Reporting of Adverse Drug Reactions (1990)
CIOMS II - International Reporting of Periodic Drug Safety Update Summaries(1992)
CIOMS III - Guidelines for Preparing Core Clinical Safety Information on Drugs (1995)
CIOMS IV 01/1995-07/1997 Benefit-risk balance for marketed drugs (1998)
CIOMS V 04/1997-08/2000 Current Challenges in Pharmacovigilance: Pragmatic Approaches (1999)
CIOMS WG on SMQs 05/2002- Development and Rational Use of Standardized MedDRA Queries (SMQs):Retrieving Adverse
Drug Reactions with MedDRA (2004)
CIOMS VI 03/2001-10/2004 Management of Safety Information from Clinical Trials (2005)
CIOMS VII - Development Safety Update Reports (DSUR): Harmonizing the Format and Content for Periodic
Safety Report during Clinical Trials (2006)
CIOMS VIII - Practical Aspects of Signal Detection in Pharmacovigilance (2010)
CIOMS/WHO WG 11/2005-10/2010 Definition and Application of Terms for Vaccine Pharmacovigilance (2012)
CIOMS IX - Practical Approaches to Risk Minimization for Medicinal Products (2014)
CIOMS X 06/2011-07/2015 Evidence Synthesis and Meta-Analysis for Drug Safety (2016)
CIOMS SMQ Implementation WG (05/2002)-2018/19 Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse
Drug Reactions with MedDRA (2016)
CIOMS WG to Vaccine Safety 2013-2016 CIOMS Guide to Active Vaccine Safety Surveillance (2017)
CIOMS Guide to Vaccine Safety Communication

11. Ongoing Working Groups
Working Group Objective
Good Governance Practice for Research
Institutions
Propose standard guidelines promoting the minimal resources needed for researchers to work in accordance with the highest
standards in research ethics and regulation.
Recommended Standards of Education and
Training for Health Professionals Participating in
Medicines Development
Propose standard guidelines promoting harmonization across all stakeholders working in and providing education in medicines
development.
Severe Cutaneous Adverse Reactions to Drugs –
SCARs
To establish a balanced, efficient, global perspective on SCAR detection, susceptibility factors, severity, outcome and probability
through causality assessment tools, monitoring and management during the drug development and post-marketing phases.
Working Group XIII – Real-World Data and Real-
World Evidence in Regulatory Decision Making
It would recommend an approach and prepare a consensus report promoting harmonization across global drug regulatory
authorities and develop a POV on ethical considerations and challenges related to RWD and RWE
Working Group XII – Benefit-Risk Balance for
Medicinal Products
THE WG will build on previous considerations established by CIOMS WG IV, incorporating the latest thinking in quantitative
and qualitative approaches to the evaluation of benefit-risk (B-R), as well as assimilating visual presentations of benefits and risks
to improve transparency and understanding amongst key stakeholders, including patients.
MedDRA Labelling Groupings It is proposed that globally harmonized principles, points to consider, and pragmatic recommendations for development of
MedDRA Labelling Groupings (MLGs) be developed by a Council for International Organizations of Medical Sciences (CIOMS)
working group.
Working Group XI – Patient Involvement (2018) It includes participants from patient organizations, industry, regulators, academia and the World Medical Association. These
experts are working together to formulate pragmatic Points to Consider in patient involvement. The guidance will provide a
comprehensive overview of present knowledge and existing initiatives, and will address a wide range of the remaining challenges
and practice gaps. The optimal consideration of patient perspectives will support the safe and effective use of medicines, thereby
helping to improve the health of individuals and the public.

12. Impact on ICH Guidelines
Working Group ICH Guideline
CIOMS WG I and II Reports
(1990,1992)
ICH-E2A (1994): Clinical Safety Data Management- Definitions and Standards for
Expedited Reporting
CIOMS IA (1992) ICH E2B: Clinical Safety Data Management – Data elements for transmission of ICSR
CIOMS WGs II and III (1992,
1995)
ICH-E2C (1996): Clinical Safety Data Management - PBRER
CIOMS WG V (2001) ICH E2D (2003): Post-Approval Safety Management – Definitions and Standards for
Expedited
CIOMS WG VIII Report ICH – E2F (2010): DSUR

13. CIOMS Form
CIOMS Reporting Form I
 Part of CIOMS PV 1st WG report (International Reporting of
ADR; initial 1987, final 1990)
 Served as a minimum standard for reporting of ADR of
licensed drugs
 Served as a template for upcoming national forms
 Accessible on CIOMS Homepage