June 2017 .
Voisin Consulting Life Sciences - White paper
Early access programmes (sometimes also called compassionate use or temporary use authorisation) were set up because of the rapid advances in science and the legitimate expectations of physicians or patients for early access to unauthorised medicinal products prior to marketing authorisation and commercial launch (with the assumption that a favourable risk:benefit exists).
This paper discusses the possible pathways to an early access programme .
Jean-Luc Béjot, Senior Medical Director; Adeline Darchy, Clinical Project Manager; Carole Jones, Director, Market Access; Emmanuel Prades, Director, Clinical Operations.