Journée de la recherche clinique
Workshop on early access and compassionate use programs facilitated by Nadine ROUMIER
The reform of the early access and compassionnate use authorisation procedures for medicinal products in July 2021 has had a major impact on the implementation of these programmes for all the players involved (healthcare professionals, manufacturers and health authorities). More than 18 months after its implementation, there is still a great deal of news surrounding early access programmes: setting up the interface with ATIH/Pasrel, compensation agreements with hospitals, new CNIL guidelines, the challenge of collecting data from healthcare professionals and patients, etc…
A quick look back at the early access workshop facilitated by Nadine ROUMIER, Head of the early access and compassionate use department, at the “Journée de la Recherche Clinique” (Clinical research day) held on 16 March 2023.
With the participation of:
Joëlle ASMAR, Senior consultant – IQVIA France, Animatrice du groupe de travail AFCROs AP/AC
Damien BRUEL, Chargé de mission – Bureau accès aux produits de santé et sécurité des soins (PF2) – DGOS
Dr Julia DULON, Pharmacien au CH de La Rochelle.
Aurore GAIGNON, Juriste Santé – CNIL
Sophie KELLEY, Cheffe du service évaluation du médicament, HAS
Camille THOMASSIN, Cheffe de la cellule de coordination des données en vie réelle, HAS