AUTHORITIES / ORGANIZATIONS
(International)
COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES
(CIOMS)
1.Introduction
The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental organisation, established jointly by WHO (IDRAC 25448) and UNESCO in 1949. Through i
ts membership, CIOMS is representative of a substantial proportion of the biomedical scientific community. The membership of CIOMS includes 17 international member organisations, representing many of the biomedical disciplines, 13 national members mainly representing national academies of sciences and medical research councils and 23 associate members.
2.Organisation
CIOMS is governed by an Executive Committee: President: Prof. J.J.M. van Delden, supported by a permanent secretariat: Secretary-General: Dr Gunilla Sjölin-Forsberg.
Address: Council for International Organizations of Medical Sciences (CIOMS)
Case postale 2100
CH-1211 Geneva 2
Switzerland
Tel: +41 22 791 64 97
E-mail: info@cioms.ch
Web–site:www.cioms.ch/
editor evaluating revision
3.Activities
The main objectives of CIOMS are:
- “To facilitate and promote international activities in the field of biomedical sciences, especially when the participation of several international associations and national institutions is deemed necessary
- To maintain collaborative relations with the United Nations and its specialized agencies, in particular with WHO (IDRAC 25448) and UNESCO
- To serve the scientific interests of the international biomedical community in general”.
To achieve its objectives, CIOMS has initiated and coordinates the following programmes:
- “Bioethics
- Health Policy, Ethics and Human Values - An International Dialogue
- Drug Development and Use
- International Nomenclature of Diseases”.
3.1Bioethics
Activities in this area have lead to the publication of several international guidelines. These include:•International ethical guidelines for epidemiological studies (2009)
•International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002).
A CIOMS Working Group on Research Ethics, established in 2012, is working on a revision of
this guideline. This will include an update of ethical aspects relating to clinical research in
resource-limited settings which was addressed in the 2005 draft report: “Drug Development
Research in resource-limited countries. How to succeed in implementation of Good Clinical
Practice Guidelines”.
•Biomedical research involving animals (1985) (revision planned).
3.2Health policy, ethics and human values
This major programme originated at an international conference organized by CIOMS and WHO (IDRAC 25448) in 1984.  This programme has provided a forum for health policy-makers, ethicists and others to consider a wide range of health related issues such as equity, social justice, community participation, and the dignity of individuals in sickness and health in the context of health policy-making.
3.3Drug development and use
This programme was initiated in the 1980s and has covered a number of projects.
3.3.1CIOMS I to X
Several CIOMS Working groups have discussed a variety of topics and issued a number of reports including:
CIOMS I International reporting of Adverse Drug Reactions (1990); Reporting adverse drug reactions: definitions of terms and criteria for their use (1999). The CIOMS I reporting form is available on the CIOMS website.
CIOMS II International Reporting of Periodic Drug-Safety Update Summaries (1993):
formed the basis for the development of the corresponding ICH guideline.
CIOMS III  Guidelines for Preparing Core Clinical-Safety Information on Drugs (1999):
elaborates the concept introduced under CIOMS II of a manufacturer’s Core Data Sheet for a product and the corresponding Core Safety Information (CSI).
CIOMS IV  Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals (1998):
provides an extension of CIOMS II and III discussing how to determine the significance of a new safety signal, the risk-benefit balance and the associated decision making processes.
CIOMS V  Current Challenges in Pharmacovigilance: Pragmatic Approaches (2001):
considers the factors that need to be taken into consideration in dealing with the drug safety of marketed drugs.
CIOMS VI  Management of Safety Information from Clinical Trials (2005):
considers issues relating to the surveillance, assessment and reporting of drug safety data from clinical trials.
CIOMS VII  Development Safety Update Report (DSUR): Harmonizing the Format and Content for Periodic Safety Reporting During Clinical Trials (2006).
CIOMS VIII  Practical aspects of Signal Detection in Pharmacovigilance (2010):
Provides guidance on the development and application of quantitative methods for signal detection
CIOMS IX Practical Considerations for Development and Application of a Toolkit for Medicinal Product Risk Management. Created in 2010 with the aim of developing guidelines for use by industry and regulators. The main focus is on risk minimization with the development of guidance containing a risk minimization toolkit for managing risks of medicinal products. This Working Group is holding regular meetings over a period of three years, and a report is expected to be published in 2013.
CIOMS X  Considerations for applying good meta-analysis practices to clinical data within the biopharmaceutical regulatory process. Created in 2011 with the aim of developing a consensus on scientific and methodological criteria that represent good practices when applied to meta-analyses of clinical data within the regulatory process. A series of meetings is being held over a period of three years, aiming for a publication in 2014.
3.3.2Other Groups
Working Groups are formed as necessary to discuss specific areas:
CIOMS/WHO Working Group on Vaccine Pharmacovigilance
The Working Group was created in 2005 to develop standardised definitions relevant to the monitoring of the safety of vaccines during clinical trials and for the purposes of vaccine pharmacovigilance in the post-authorisation period.
Report issued: Position Paper on Vaccination Failure (2008)
Report issued: Definition and Application of Terms for Vaccine Pharmacovigilance (2012).
CIOMS Working Group on Vaccine Safety
The Working Group was recently created and will have their first meeting at the EMA, London, UK on 29-30 May-2013. This is linked to the activities of the Global Vaccine Safety Blueprint of WHO (IDRAC 25448) and its implementation plan, the Global Safety Vaccine Initiative (GVSI). It is a global strategic plan that aims at assisting low and middle income countries (LMIC) in their work with vaccine safety surveillance.
The initial duration of the Working Group is for three years but may be extended to 2020 in order to align with the WHO GVS Initiative.
CIOMS Working Group on Standardised MedDRA Queries (SMQs)
Since 2003, the Group, which operates in close collaboration with ICH (IDRAC 4726), has developed search queries for selected adverse reactions based on MedDRA in order to enable the rational use of terminology, thereby facilitating comparisons of drug safety findings between databases. A total of 90 SMQs will complete the originally contemplated work programme for SMQ development.
Report issued: Development and Rational Use of Standardised MedDRA Queries (SMQs) (2004) (revision planned).
Note: Another working group is under consideration relating to the idea to “merge the PSUR, DSUR, RMP Safety Specification and Signal detection assessment report into one single Drug Safety Master File that could also be used for answering the questions of regulators within the context of a referral and serve as a basis for identifying the risks to be included in a formal benefit/risk assessment report”. (Executive Committee Meeting Nov-2012)
4.Further information
Information for Sections 1 to 3 has been mainly derived from the CIOMS web-site: www.cioms.ch/. CIOMS documents are not available on IDRAC for copyright reasons. Information on CIOMS documents may be obtained from the CIOMS website.
Source: Consultant
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