Planning for the complexities of regulatory nuances with appropriate internal investment sets the foundation for a successful Expanded Access Program (EAP) strategy
Dr. Olga Fidalgo González
Associate Vice President
Dr. Friederike Winter
Global Early Access Programs (EAPs) can be a valuable component of an innovative product strategy, as they provide high-need patients with access to novel therapeutics; however, designing an effective global EAP strategy is complex. The many variables – internal company resources, multiple stakeholder requirements and different countries’ rules and regulations – require multiple decision points and cross-functional coordination during planning.
In this white paper, we look at the impact of EAPs and outline a selection of key considerations to craft a successful EAP strategy that helps to identify feasible pathway options and support appropriate decision making.
This white paper explores:
- The impact of EAPs on a product’s ecosystem
- A case study review of EAP success stories
- Key complexities and factors to consider when developing a successful EAP strategy
Download your free copy of the white paper by completing the form.