12 March, 2015
Voisin Consulting Life Science – 64 Avenue Pierre Grenier, 92100 Boulogne-Billancourt
At VCLS, we maintain established relationships with local health authorities and communicate with them regularly. As an example, VCLS communicated regularly with the French data protection authority regarding the authorization of data processing as part of compassionate use programs (CUPs). The review of these authorization requests used to take 2-4 months.
VCLS raised the point that these review timelines were not in line with the objective of CUPs, which is to provide a medicinal product as fast as possible to patients with a life-threatening or debilitating disease and who have no other therapeutic alternatives. VCLS expressed the need for a simplified procedure for the authorization of data processing in the framework of CUPs, in line with what is already in place for other types of data processing.
It was recently announced that a new procedure has been put in place by the French data protection authority to simplify this particular process. We are pleased to have played our part in this important development, which is in the interest of patients.
VCLS works with high standards of quality. Our exhaustive cross-understanding of regulatory processes enables us to influence regulatory bodies in order to remove roadblocks for our clients and contribute to facilitating patients’ access to medicines.
Contact us to find out more.