Adaptive pathways is a scientific concept for medicine development and data generation which allows for early and progressive patient access to a medicine. The approach makes use of the existing European Union (EU) regulatory framework for medicines. Adaptive pathways is based on three principles: iterative development, gathering evidence through real-life use to supplement clinical trial data, early involvement of patients and health-technology-assessment bodies/payers in discussions on a medicine's development. In this session, we want to discuss the opportunities and potential challenges for implementing the adaptive pathways concept in Europe, with a specific focus on CEE countries. The session is hosted by the ADAPT SMART consortium. The consortium brings together patients, regulators, industry, health technology assessment (HTA) bodies, payers, and academics to identify more efficient ways of developing and regulating medicines and provide patients with timely access to beneficial medicines access to innovative medicines.