EMA road map A key issue for Regulators will be if a more staggered approval should be envisaged, characterised by –a better defined / more restricted population of good responders, –followed by a broadening of the population post- authorisation when more real life data are available In addition, maximising the value of information generated in the post-authorisation phase should be developed through the use of cohorts and other prospectively collected use data, especially in the case of conditional marketing authorisations.