Real-World Evidence (RWE) Generation and Localization in Saudi Arabia (Pharmaceuticals)

(Pharmaceuticals) A key vulnerability identified by Saudi HTA authorities is over-reliance on clinical trial data generated outside the Kingdom, which fails to reflect local patient genetic responses, adherence rates, and clinical realities. The SFDA's Form A protocols demand localized epidemiological data and regional sub-group analyses. This program addresses that gap by training clinical and medical-affairs professionals in the design, ethical approval, and execution of local observational studies. Participants learn techniques for accessing unified electronic health records and compliantly mining patient disease registries distributed across the regional clusters under the Health Holding Company. The curriculum covers study design, data governance, ethics submissions, and analytical methods suited to observational data. By generating robust localized Real-World Evidence, companies overcome the external-validity limitations of global randomized controlled trials, satisfy SFDA dossier requirements, and build the evidence base needed for outcome-based reimbursement and managed entry agreements. The program equips teams to transform fragmented local data into credible, regulator-ready evidence that strengthens market access across the Saudi multi-payer system.