PharmaBlue Support for pharmaceutical companies looking to run French expanded access programs
As we have seen, there are some situations where patients have a life threatening or orphan disease, and their physicians have exhausted all available treatment options or there is simply no treatment. Some country-specific mechanisms exist across the globe to enable access to pre-approved or unlicensed medicines outside of clinical trials.
These mechanisms support and an earlier access to more and more innovative medicines for patients.
- PharmaBlue is composed of experts in preparation and submission of early access dossiers in compliance with the current regulations and also through the new pilot schemes.
- PharmaBlue has the skills and expertise to implement early access programs and patient follow-up in line with the current regulations and with pharmacovigilance (PV) requirements.
- The PharmaBlue team worked in close collaboration internally and with the client.