Registry Workshop - Preparing for Future Requirements

With the implementation of Benefit/risk assessment of medicine post approval, data from usual practice has become even more important. Even though registries/database have been used for decades, the terminology, coding systems, design, regulations, funding, analysis, reporting etc. is inconsistent. Even the basic terms as registry and database are used with opposite meanings. Current activities focus on the basic registries: product and disease registries. These registries are typically short lived due to funding, and clearly inferior to patient and other global registries with unique person identifiers. This session sets the scene from a EU/USA perspective.