ISOPP CAPhO 2025 Symposium: Expanded Access and Compassionate Use, the Brazilian Scenario

Clinical research offers patients with various diseases the opportunity to access innovative medicines. Clinical studies have different inclusion and exclusion criteria and are not always an option for patients with intractable diseases. This is when Expanded Access and Compassionate Use become an opportunity for free access to innovative treatments. In Brazil, these programs are governed by a specific resolution (RDC), which regulates their implementation and oversight. This presentation will focus on exploring this resolution.

Learning Objectives

• Differentiate between expanded access and compassionate use
• Describe Brazilian scenario related to expanded access and compassionate use
• Explain the role of the pharmacist in this context