logoCiomsBlueThe Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949. In 2009 CIOMS celebrated the 60th anniversary of its creation.

Through its membership, CIOMS is representative of a substantial proportion of the biomedical scientific community. In 2013, the membership of CIOMS included 49 international, national and associate member organizations, representing many of the biomedical disciplines, national academies of sciences and medical research councils. The main objectives of CIOMS are:

Read more: About Us

logoCiomsBlueThe December 2014 Newsletter presents reports from the
Executive Committee of CIOMS, CIOMS Working Group on Vaccine Safety, the launch of report of CIOMS Working Group IX on“Practical approaches to Risk Minimisation for Medicinal Products and the CIOMS Working Group X on “Considerations for applying good meta-analysis practices to clinical safety data within the biopharmaceutical regulatory process”.

click here to read the Newsletter...

 

 

 

Practical approaches to risk minimisation for medicinal productsThe Council for International Organizations of Medical Sciences (CIOMS) announces the publication of Practical approaches to risk minimisation for medicinal products: Report of CIOMS Working Group IX.
 
Medical science continues to bridge new frontiers with an ever-widening array of medicinal products to treat illnesses and health conditions.  No medicine is devoid of risk, however, and for that reason, it becomes paramount to appropriately manage all kinds of risks, from the very minor ones to those with serious adverse effects, with the objective being a positive balance of benefits to risks.  Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large.

Read more: New publication: Practical Approaches to Risk Minimisation for Medicinal Products

CIOMS MexicoAt a symposium during the 12th World Congress of the International Association of Bioethics in Mexico City, 25-28 June 2014, members and advisors of the CIOMS Working Group for the Revision of 2002 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects presented and discussed key issues in this process. The focus of the session was on aspects of CIOMS guidelines when used in low- and middle-income countries, social value, and research including vulnerable persons. A good number of 80-90 of the congress participants attended the symposium and a lively discussion in which many helpful remarks were made took place. This session served as one element of CIOMS’ international consultation process regarding the proposed revisions of the CIOMS Guidelines.

 Below are the presentations of the session:

 

Read more: Update: CIOMS Symposium at the 12th World Congress of the International Association of Bioethics,...

logoCiomsBlueIn September 2012 the Working Group on the Revision of the 2002 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects held its first meeting in Geneva.  Since then continuous work, including six face-to-face meetings and repeated interaction in between, has resulted in good progress and has kept pace with recent developments in the field of biomedical research and a revised Declaration of Helsinki.

Read more: CIOMS Symposium at the 12th World Congress of the International Association of Bioethics, Mexico...

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Elections were held at the CIOMS 80th Executive Committee Meeting and XXIst General Assembly on 20 November 2013, and we are pleased to announce the following new officers and members: 

 

 

 

Read more: General Assembly of CIOMS in Geneva

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A CIOMS INTERNATIONAL WORKSHOP on “Considerations on benefit sharing” was held in conjunction with the General Assembly at WHO Headquarters on the same day between 08:45 to 11:45 on Wednesday, 20 November 2013.

Speakers were: Dr Stefano Semplici, Chair, International Bioethics Committee, University of Rome Tor Vergata, Italy; Dr Alex John London, Carnegie Mellon University, Pittsburgh, PA, USA; Dr Ruth Macklin, Albert Einstein College of Medicine, New York, USA; and Dr Dirceu Greco, Federal University of Minas Gerais, Belo Horizonte, Brazil. Dr Rodolfo Saracci chaired the meeting.

CIOMS is very grateful for the contribution from all to a very successful meeting!

Members of this CIOMS Working Group at the second meeting held on 26-28 June 2013 in Utrecht, the Netherlands.In 2010 the Executive Committee of CIOMS decided to revise the CIOMS Ethical Guidelines for Biomedical Research. The document was last revised in 2002 and since then, several developments have taken place, both in the field of biomedical research itself and in the field of research ethics. Among the latter developments is the recent revision of the Declaration of Helsinki in 2013.

Read more: CIOMS Working Group on the Revision of the 2002 CIOMS Ethical Guidelines for Biomedical Research

Group5 Pharmacovigilance-1

The CIOMS V Working Group (WG) met in a series of 8 formal meetings during the years 1997 to 2000. The printed version of their report ”Current Challenges in Pharmacovigilance: Pragmatic Approaches” was published in 2001. The CIOMS WG V, through its report,  advocated acceptance for a wide range of proposals concerning issues covering terminology and definitions, common every day practices such as follow-up of individual adverse events, the rational scheduling and content of periodic safety update reports (PSURs), the role of internet and quantification of population drug use.  The completed report, intended as a handbook for pharmacovigilance departments and still offering many pragmatic solutions to a number of issues, has been in great demand. CIOMS has now decided to make the publication available free of charge to download on its website.

Click here to access the download page

CIOMS Working Group on Vaccine SafetyA new CIOMS Working Group (WG) has been established to address issues related to the information exchange between stakeholders on vaccine safety. The formation of the new WG is linked to the activities of the Global Vaccine Safety Blueprint of WHO and its implementation plan, the Global Vaccine Safety 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 importance of close collaboration between stakeholders is well recognized in vaccine pharmacovigilance activities, and guidance has been developed, in industrialized countries, for jointly planning these activities.

Read more: NEW! CIOMS Working Group on Vaccine Safety

More Articles...

  1. CIOMS and ICLAS release the new International Guiding Principles for Biomedical Research Involving Animals
  2. New publication: The Role of Clinical Pharmacology in Health Care, Teaching and Research
  3. CIOMS Executive Commitee Meeting: 79th Session in Salle G, WHO Headquarters, Geneva, Switzerland
  4. First meeting of the new CIOMS Working Group on research ethics in Geneva
  5. CIOMS Working Group IX on "Practical Considerations for Development and Application of a Toolkit for Medicinal Product Risk Management"
  6. CIOMS Working Group X on "Considerations for applying good meta-analysis practices to clinical safety data within the biopharmaceutical regulatory process"
  7. CIOMS Working Group on Standardised MedDRA Queries (SMQs)

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New Books



Practical Approaches to Risk Minimisation for Medicinal Products: Report of CIOMS Working Group IX  

The Council for International Organizations of Medical Sciences (CIOMS) announces the publication...

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New Meetings


8th Working Group on Revision of CIOMS International Ethical Guidelines, Vilnius, Lithuania, 22-24 March 2015

Recent Meetings

81st CIOMS Executive Committee Meeting, Geneva, Switzerland, 18 November 2014

7th Working Group on Revision of CIOMS International Ethical Guidelines, Geneva, Switzerland, 12-14 November 2014

5th Vaccine Safety Working Group, Rabat, Morocco, 24-25 September 2014

8th Working Group X on Meta-analysis, Basel, Switzerland, 30 September – 1 October 2014

MedDRA 6th IWG Meeting, ICH, Geneva, Switzerland, 14-16 October 2014

6th Working Group on Revision of CIOMS International Ethical Guidelines, Geneva, Switzerland, 21-23 May 2014

4th Vaccine Safety Working Group, UMC, Uppsala, Sweden, 20-21 May 2014

5th Working Group on MedDRA, ICH, Geneva, Switzerland, 9-10 April 2014

5th Working Group on Revision of CIOMS International Ethical Guidelines, Utrecht, Netherlands, 26-28 February 2014

7th Working Group X on Meta-analysis, Durham, North Carolina, USA, 25-26 February 2014

3rd Vaccine Safety Working Group, CDC, Atlanta, GA, USA, 5-6 February 2014

CIOMS 80th Executive Committee Meeting, XXI General Assembly & Workshop, 20 November 2013, WHO Headquarters, Geneva, Switzerland

CIOMS 4th Working Group on Revision of CIOMS International Ethical Guidelines, 17-19 November 2013, WHO Headquarters, Geneva, Switzerland

CIOMS Working Group on Vaccine Safety, 17-18 September  2013, WHO Headquarters, Geneva, Switzerland

CIOMS WG X on Considerations for applying good meta-analysis practices to clinical safety data within the biopharmaceutical regulatory process, 12-13 September 2013, Singapore

CIOMS Working Group on the Review of 2002 International Ethical Guidelines, 26-28 June 2013, UMC, Utrecht, The Netherlands

CIOMS WG on Vaccine Safety, 29-30 May 2013 , EMA, London, UK

CIOMS Working Group on the Review of 2002 International Ethical Guidelines, 11-12 February 2013, Geneva, Switzerland

CIOMS Working Group X, 14-15 March 2013, MEB, Utrecht, The Netherlands

CIOMS Working Group IX, 18-19 March 2013, NDA, Stockholm, Sweden

MedDRA 3rd IWG Meeting, 9-10 April 2013, IFPMA/CIOMS, Geneva, Switzerland

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