To guide and steer this discussion, the speaker will introduce the key decision-making paths for MD&D reimbursement in specific countries/regions, to compare and contrast evidence requirements, and explore whether RWE can meet these needs. These elements will be accompanied by examples that will consider the impact of HTA barriers, RWE definitions, and RWE validation related to the country/region, in order to make them acceptable to decision-making bodies. Then, the debate will focus on the advantages and limitations of real-world data in the context of accounting decisions; This will include the acceptance of RWE from other regions (such as the United States) in Europe, compliance with GDPR rules for the use/access of RWE, and ensuring RWE quality perspectives that meet the purpose.