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Summary of report of the 3rd Workshop of European Biologics Registries
  1. A Zink1,
  2. A Silman2,
  3. L Klareskog3
  1. 1Deutsches Rheuma-Forschungszentrum Berlin, Berlin, Germany
  2. 2ARC Epidemiology Research, University of Manchester, UK
  3. 3Karolinska Hospital, Stockholm, Sweden
  1. Correspondence to:
    Dr A Zink

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The national societies of rheumatology in several European countries have initiated independent registries to observe the long term outcomes (safety, effectiveness, and costs) of treatments with biological agents. The third meeting of biologics registries was held in January 2004 in Berlin with 45 representatives from the existing or planned registries in Europe and Canada together with representatives from the following companies: Abbott, Amgen, Centocor, Schering-Plough, and Wyeth.

Initial experiences with the use of register data for satisfying the reporting requirements of the European Medicines Evaluation Agency (EMEA) were discussed as well as methodological issues such as the role of a control group of non-biologic treated patients, attribution of events to treatments (especially when treatments are changed), coding of adverse events, and interpretation of findings. The next meeting of biologics registries will be held in Stockholm in May 2005 under the auspices of EULAR.

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