European Medicines Agency 186d ago

00:00:40 Welcome / Introductions 00:06:20 Electronic application forms (eAF) 0:21:00 Electronic Common Technical Document version 4 (eCTD4) 00:35:40 Union Product Database (UPD) 00:51:00 Product Management Service (PMS) 01:22:15 Product user interface (PUI) 01:41:45 Electronic product information (ePI) 02:00:55 Regulatory Procedure Management (RPM) for Product Lifecycle Management on IRIS 02:29:50 Clinical Trials Information System (CTIS) modernisation – new CTIS safety module 02:52:25 Antimicrobial Sales and Use (ASU) platform 03:04:00 Data Analytics Platform (DAP) – Business Intelligence (BI) reports for National Competent Authorities 03:10:45 Date of next system demo