Public System Demo 25Q4
Автор: European Medicines Agency
Загружено: 2025-12-16
Просмотров: 2182
Описание:
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
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