From R&D, regulatory approval pathways to considerations for launching cell and gene therapies, this session is intended to shed a light on European and Middle Eastern (focus on Saudi Arabia and UAE) regulations and policy initiatives to accelerate approvals of advanced therapies. Additionally, panelists will discuss the need to understand and navigate the landscape governing early access and commercialization of such products with a plethora of aspects to consider such as collection and export of cells, transfer of ownership of cells, the risk management system and post-marketing obligations, the relationship with the healthcare institution, contractual arrangements, personal and health data transfers, cross-border healthcare including pricing, and reimbursements issues.