EMA Clinical Trials Information System - Sponsor user training programme

Practical, hands-on training course on CTIS system functionalities including the creation and submission of an initial application, respond to RFIs, submitting a substantional modification, search and download options. Participants receive access to the CTIS training environment and will practice basic functionalities during the live training course.

Send Email +41.61.225.51.51

会议日程

天 1 2024 年 06 月 10 日

9:00 AM — 1:30 PM

Overview of CTIS components & functionalities, sponsor user access management, sponsors roles and permissions,

9:00 AM — 1:30 PM

Welcome and Introduction

天 2 2024 年 06 月 11 日

9:00 AM — 1:30 PM

Create, submit, cancel and withdraw an initial application, respond to Request For Information (RFI)

天 3 2024 年 06 月 12 日

9:00 AM — 1:30 PM

Update an initial application - substantial & non-substantial modification, manage a clinical trial through CTIS

天 4 2024 年 06 月 13 日

9:00 AM — 1:30 PM

Sponsor view, search and download options, create & submit an Annual Safety Report (ASR), Clinical Study Report (CSR) submission

EMA Clinical Trials Information System - Sponsor user training programme

会议日程

获得信息并保持参与