Timetable: Initial (full) marketing authorisation application accelerated assessment timetables
Clinical Trials Information System (CTIS) sponsor end user training programme - November 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 25 November 2025, 14:00 (CET) to 28 November 2025, 18:30 (CET)
Timetable: Initial (Full) marketing authorisation application - ATMP
Clinical Trials Information System (CTIS) sponsor end user training programme - March 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 25 March 2025, 09:00 (CET) to 28 March 2025, 13:30 (CET)
CTIS newsflash - 14 January 2025
Timetable: Informed consent and multiple application
Timetable: Initial (full) marketing authorisation application assessment
Pharmacovigilance Risk Assessment Committee (PRAC): 13-16 January 2025, European Medicines Agency, Amsterdam, the Netherlands, from 13 January 2025 to 16 January 2025
Agenda of the CVMP meeting 14-15 January 2025
Orphan designation: Davunetide Treatment of activity-dependent neuroprotective protein (ADNP) syndrome, 13/12/2024 Positive