11:00-11:45 Registration and coffee 11:45-13:00 Federal Agency for Medicines and Health Products, FAMHP update Spearhead: Early phase development Walter Janssens Scientific and Regulatory advice Christophe Lahorte DG PRE authorisation in general, UMN and CTR on national and EU level Greet Musch 13:00 ? 14:00 Lunch and networking