If you are developing a drug for a rare disease in the European Union, you may qualify for an Early Access program to expedite your clinical development. There are two key advantages to obtaining this:
- Accelerated assessment of your market access application.
- Compassionate use, where patients fulfilling certain criteria, may use your product before its final authorization or commercial availability.
In this case study, we explore the context of a pharmaceutical company seeking strategic support from us, to expedite their clinical development in France through an Early Access Program. The first challenge was the preparation of an Early Access Program Protocol for collection of real-world data, as well as the definition of a pricing strategy.
Furthermore, ongoing changes to the French framework, meant the company applied for the program under the old framework and received no response from the authorities. Therefore our team, stepped in to advise them on the updated regulatory requirements, lead the dialogue with the notified body, and write the protocols to ensure a successful application.
Read more details below on how we ensured the client’s success.
Publish date: Jan 2023