The Work of the Council for International Organizations of Medical Sciences (CIOMS) in Global Pharmacovigilance
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The Work of the Council for International Organizations of Medical Sciences (CIOMS) in Global Pharmacovigilance Manal M. Younus1 · Monika Zweygarth2 · Lembit Rägo2 · Mira Harrison‑Woolrych3 Accepted: 11 September 2020 / Published online: 9 October 2020 © Springer Nature Switzerland AG 2020
1 Introduction “CIOMS” is not an acronym that is widely known, and yet CIOMS guidelines have impacted and shaped the work of the World Health Organization (WHO), medicines regulatory authorities, academic organizations, the pharmaceutical industry, and other stakeholders globally in past decades. Co-founded by the WHO and UNESCO in 1949, the Council for International Organizations of Medical Sciences (CIOMS) has as its mission to advance public health through guidance on health research, including ethics, medical product development, and safety [1]. CIOMS has produced numerous guidance documents in the areas of bioethics, pharmacovigilance, and drug development and its publications have been translated into many languages including Chinese, Japanese, Russian, and Spanish [1]. This editorial provides an introduction to the work of CIOMS in the field of pharmacovigilance and highlights the relationship between the International Society of Pharmacovigilance (ISoP) and CIOMS.
2 CIOMS Organization CIOMS is a non-governmental, not-for-profit international association under Swiss law. Since 2016, it is an observer member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). * Manal M. Younus [email protected] 1
Iraqi Pharmacovigilance Center, Ministry of Health, Baghdad, Iraq
2
Council for International Organizations of Medical Sciences (CIOMS), Geneva, Switzerland
3
International Society of Pharmacovigilance (ISoP), London, UK
CIOMS membership is open to “organizations … devoted to the encouragement of scientific research into the principles underlying health and into the causes of diseases, or the application of the medical sciences to the prevention and cure of diseases and to the promotion of public health” [2]. It has international members, e.g., the World Medical Association, ISoP, the International Society of Pharmacoepidemiology, and the International Union of Basic and Clinical Pharmacology as well as national members, e.g., the Academies of Medical Sciences of Belgium, Korea, and Switzerland and the Medical Research Councils of Bangladesh, India, and South Africa. In addition, there are associate members who do not meet all the membership criteria, or wish to be more like observers, e.g., the Saudi Neonatology Society. Representatives of CIOMS member organizations can be elected as Executive Committee members and can participate in the General Assembly (meets every 2 years and alternate years by teleconference, decisions are adopted by consensus), [2] and the member organizations are kept informed of CIOMS, ICH, and WHO activities and publications. The CIOMS member organizations, through their own members, for example the World Med
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