An expanded access programme is a legislative framework, used by both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) to enable the therapeutic use of an unauthorised intervention (or of an authorised drug for an unauthorised indication) for patients with a life-threatening disease, outside of a clinical trial.

These programmes require a minimum set of safety data collection and also offer the opportunity to collect “standard of care” or real-world data alongside. As regulators are increasingly asking for RWD as part of a regulatory submission, there is an increased interest in how to operationalise RWD. In France, the HAS made the collection of real world data in managed access programmes mandatory in 2021.

This webinar is intended for pharma and biotech companies who support expanded and early access programmes, and explores:

• Key considerations on the benefits and risks of collecting RWD in EAPs
• A framework for evaluating what real world data to collect
• How to align internal stakeholders
• Operational considerations: HCP, Patients and process
• Success factors for RWD
• Case studies