Myriam Antoun

Pharmaceutical regulatory affairs professionals play a crucial role in the reimbursement process. While reimbursement itself is often associated with health economics and market access professionals, regulatory affairs professionals contribute significantly to this process. As such, knowledge of health technology assessments (HTAs), economic modelling, and other factors that influence reimbursement decisions is critical.

Demonstrating the "value" of medicines is vital for securing market access and reimbursement, justifying economic considerations to reimbursement agencies. The presentation will introduce the concept of the the new evidence triad: Safety, Efficacy and Value. A review of the traditional lifecycle process, changing healthcare environment, ethics discussion, as well as the existing comparative framework will be provided.