Webinar: How to successfully operationalize real-world data collection alongside expanded access programs
On 05 October, Boyds will be co-hosting a live webinar with Cisiv, discussing how to successfully operationalize real-world data collection alongside expanded access programs.
An expanded access program 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 unauthorized intervention (or of an authorized drug for an unauthorized indication) for patients with a life-threatening disease, outside of a clinical trial.
These programs 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 operationalize RWD. In France, the HAS made the collection of real-world data in managed access programs mandatory in 2021.
This webinar is intended for Pharma and Biotech companies who support Expanded and Early access programs, and will explore:
- 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