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Uppsala Monitoring Centre (UMC) is a non-profit foundation working for the safer use of medicines and vaccines. Located in
Uppsala Uppsala ( ; ; archaically spelled ''Upsala'') is the capital of Uppsala County and the List of urban areas in Sweden by population, fourth-largest city in Sweden, after Stockholm, Gothenburg, and Malmö. It had 177,074 inhabitants in 2019. Loc ...
,
Sweden Sweden, formally the Kingdom of Sweden, is a Nordic countries, Nordic country located on the Scandinavian Peninsula in Northern Europe. It borders Norway to the west and north, and Finland to the east. At , Sweden is the largest Nordic count ...
, UMC is the designated
World Health Organization The World Health Organization (WHO) is a list of specialized agencies of the United Nations, specialized agency of the United Nations which coordinates responses to international public health issues and emergencies. It is headquartered in Gen ...
Collaborating Centre for International Drug Monitoring. UMC works by collecting, assessing and communicating information from member countries' national
pharmacovigilance Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots ...
centres in regard to the risks of medicines and vaccines.


Background

Since 1978, responsibility for managing the WHO Programme for International Drug Monitoring has been carried by UMC. In the early years the staff consisted of just three pharmacists, Sten Olsson, Cecilia Biriell and Marie Lindquist, based at the Swedish Medical Products Agency (Läkemedelsverket); Currently over 150 staff work in central Uppsala. The founding chairman and acting Director was Professor Åke Liljestrand. From 1990 to 2009 the Director was Professor Ralph Edwards. In 2009, Dr. Marie Lindquist became the Director until her retirement in 2020. Hervé Le Louët served from 2021 to 2022 and was succeeded by Peter Hjelmström. The Head of Research is Dr. Niklas Norén. The work of the UMC is: * To co-ordinate the WHO Programme for International Drug Monitoring and its more than 150 member countries. * To collect, assess and communicate information from member countries about the risks of drugs and other substances used in medicine to improve patient therapy and public health worldwide. * To collaborate with member countries in the development and practice of the science of pharmacovigilance. The main focus and source of data in
pharmacovigilance Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots ...
are reports of ICSRs (individual case safety reports) from healthcare providers and patients in member countries of the WHO Programme. A WHO global individual case safety report database ( VigiBase) is maintained and developed on behalf of the WHO by UMC. UMC develops and provides several tools and classifications for use by organisations involved in drug safety, including the WHO Drug Dictionary – with a bridge to the
MedDRA A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical ...
terminology and WHO ICD – tools for searching in the database, and a program for case report management, VigiFlow. UMC's research covers mainly three areas: data-driven discovery (especially statistical techniques), dis-proportionality analyses, interaction detection, patterns and duplicate case detection, safety surveillance and signaling (among which drug dependence and pediatric use) and benefit—risk analysis. As of 2023 over 200 scientific articles in peer-reviewed journals were linked on the centre's website. Telerx website; description and critique of the Uppsala Monitoring Centre
retrieved 28 January 2014.
UMC has been active in initiatives to improve communication in areas related to medicines safety since 1996. The centre has been active in presenting research in the medical literature which has included some seminal works in the field. The Uppsala centre has also published books in the field of drugs safety including a regular newsletter.''Textbook of Pharmacovigilance (Chapter 11).'' Ed: SK Gupta. Jaypee Brothers Medical Publishers, New Delhi, 2011. In 2010 the 2nd edition of a crisis management guide was published, entitled 'Expecting the Worst', also translated into other languages.Clark D. Review: Expecting the Worst – a publication from the Uppsala Monitoring Centre. ''Drug Safety'' 2010; 33(12):1135–36. UMC's role in drug safety has not been without controversy for both medicines agencies and pharmaceutical companies, despite an open approach willing to engage with many parties in the pharmaceutical world. They are closely involved in outreach to developing countries and other areas where pharmacovigilance is not yet handled.


See also

*
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of p ...
(ICH) *
Council for International Organizations of Medical Sciences The Council for International Organizations of Medical Sciences (CIOMS) is an international non-governmental organization of 40 international, national, and associate member groups representing the biomedical science community. It was jointly est ...
(CIOMS) * International Society of Pharmacovigilance *
EudraVigilance EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected Adverse event, adverse reactions to medicines or devices which hav ...
(EEA) *
Yellow Card Scheme The Yellow Card Scheme is the United Kingdom's system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored. Histor ...
(UK) *
Clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
*
Drug development Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regu ...
*
MedDRA A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical ...


References


External links


Uppsala Monitoring Centre website

Uppsala Reports is UMC's magazine for everyone concerned with the issues of pharmacovigilance
{{Authority control World Health Organization Pharmacological societies Pharmaceuticals policy International medical and health organizations Organizations established in 1978 World Health Organization collaborating centres 1978 establishments in Sweden 20th-century establishments in Uppsala County