The MAH shall provide physicians prior to launch with an educational material that will include the following components of information: • Need and clinical importance of adverse drug reaction (ADR) reporting in general. • Background data on erythropoietin antibody-mediated pure red cell aplasia (AEAB-mediated PRCA) associated with erythropoiesis stimulating agents (ESA) treatment. • List of diagnoses or adverse events (AE) terms that trigger ADR reporting for MIRCERA. • A questionnaire to gather detailed ADR report documentation. • The MAH’ s offer of testing or re-testing antibody (AB) status in a reference laboratory. • Literature to provide information on loss of effect and its differential causes, the definition of AEAB-mediated PRCA, the diagnostic work-up of potential AEAB-mediated PRCA, the need of discontinuation of ESA treatment due to cross-reactivity with other ESAs on diagnosis of AEAB-mediated PRCA..