Being a member of the WHO Programme - Uppsala Monitoring Centre

Member countries are invited by WHO to the National Centres Annual Meeting which isusually held between October and December. These annual meetings provide good opportunitiesfor learning, networking and discussions regarding topical pharmacovigilance issues both inrelation to methodological developments and individual medicines. It is highly recommended fornational centres to be represented at these meetings, although funding and some knowledge ofEnglish are required.UMC also runs a two-week pharmacovigilance training course in Uppsala in May every year.The course is intended for healthcare professionals who have recently become engaged in theoperation of spontaneous adverse reaction reporting programmes in a hospital, regulatory orindustry setting. Theoretical and practical aspects of adverse drug reactions and pharmacovigilanceare covered.WHO supports or organizes pharmacovigilance training courses in regions of the world on anad hoc basis, depending on local needs and the availability of funds. These training courses aresometimes focused on pharmacovigilance in Public Health Programmes, e.g. for managers inmalaria or HIV/AIDS programmes.WHO also organizes Technical Briefing Seminars annually in Geneva with the objective ofadvancing collaboration between WHO and other stakeholders from governmental and nongovernmentalorganizations engaged in promoting the quality and safety of medicines in theglobal community.Membership obligations – what we expect from youTo ensure the most effective global safety monitoring by keeping VigiBase up to date withinternational patient safety data, member countries are expected to submit ICSRs to UMC atleast every quarter and preferably more frequently than once a month. If a member country, forany reason, temporarily cannot comply with this obligation, UMC must be informed. Failure tocommunicate with UMC could lead to loss of some membership privileges.Reporting format compatibility and quality of ICSRsICSRs should be submitted to UMC in the International Conference on Harmonization E2B(ICH E2B) format. This is the international standardized format for electronic transmission ofICSRs and includes all relevant data fields, which allows for a comprehensive medical analysisof the data. UMC still accepts ICSRs submitted in the old WHO format (INTDIS) from somemember countries but all countries are strongly recommended to convert to the ICH E2B format.VigiFlow is offered to all new member countries and to current members who want to convertto an ICH E2B compatible national database (see page 4).To ensure the availability of high quality data in VigiBase, member countries are expectedto submit complete ICSRs to UMC. With the exception of confidential patient and reporterdetails, no information available on the original report should be left out when transmitting anICSR; the more information on a case, the simpler and more accurate the assessment. UMCcomplies with EU data protection law, and adheres to the guidance in ICH E2B for protectingpatient and reporter confidentiality.6Membership obligations