The aim of this dissertation is to fill in the knowledge gaps on the use of biologics during pregnancy in women suffering from immune-mediated autoimmune diseases (IMIDs). To address this aim we used different information sources: for retrospective studies data was assembled from European Medicines Agency’s (EMA) EudraVigilance database; for prospective studies, patients were included from the Preconceptional Counselling in Active Rheumatoid Arthritis (PreCARA) cohort at Erasmus Medical Center in Rotterdam, the Netherlands.