Health-Related Quality of Life (HRQoL) and PROMs Localization (Pharmaceuticals)

(Pharmaceuticals) As the SFDA enforces mandatory Cost-Utility Analyses for innovative biologics, the ability to measure and quantify subjective patient outcomes has become non-negotiable. This program delves into the methodologies of capturing valid Health-Related Quality of Life (HRQoL) data using standardized psychometric instruments, equipping HEOR and medical-affairs professionals to generate utility evidence that withstands regulatory scrutiny. Participants learn the algorithms required to translate HRQoL survey metrics into utility scores suitable for QALY calculations, mastering instruments such as generic preference-based measures and disease-specific tools. Recognizing regional cultural, linguistic, and societal variances, the training places heavy emphasis on rigorous validation, precise forward and back translation, and cultural adaptation of Patient-Reported Outcome Measures (PROMs) for the Saudi demographic. Through hands-on exercises, participants follow the full localization workflow, from conceptual equivalence and cognitive debriefing to psychometric revalidation in a Saudi population. The course directly addresses SFDA Form B requirements, demonstrating how culturally adapted and properly validated PROMs prevent dossier rejections based on invalid or culturally irrelevant utility data. The outcome is a defensible, compliant capability to produce Saudi-relevant HRQoL evidence that strengthens economic submissions.