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Health Technology Assessment (HTA) and SFDA Regulatory Compliance (Hospitals)

(Hospitals) Integrate SFDA compliance and the GHAD system with localized HTA to adopt high-cost innovation within capped budgets.

Beginner
Last updated: September 2026

Course Description

(Hospitals) The Saudi Food and Drug Authority (SFDA) has positioned the Kingdom as a regional hub for technological integration and medical innovation, recently approving over 149 clinical trials covering AI-powered diagnostic tools such as Dose Check and INOVA, and high-cost gene and cell therapies such as Zolgensma and Casgevy. The SFDA regulates procurement and market authorization through its Unified Electronic System (GHAD). This program integrates SFDA compliance with localized Health Technology Assessment (HTA) principles, equipping procurement officers, regulatory-affairs specialists, and innovation managers to evaluate the clinical efficacy and long-term financial impact of integrating high-cost innovations into the cluster network. Participants learn to navigate device registration through GHAD, run rigorous cost-benefit analyses, and assess technologies against regional disease-burden data. By bridging regulatory compliance with localized economic evaluation, clusters can expedite the compliant integration of life-saving technologies while maintaining strict fiscal discipline within capped budgets. Applied workshops ground each concept in real Saudi approval scenarios, preparing leaders to make defensible, evidence-based technology-adoption decisions.

What You'll Learn

Module 1 - The SFDA Innovation Landscape
Module 2 - SFDA Compliance and the GHAD System
Module 3 - Localized HTA Methodology
Module 4 - Cost-Benefit and Disease-Burden Analysis
Module 5 - Compliant Technology Adoption Decisions