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EMA Clinical Trials Information System - Sponsor user training programme

Demonstrations and explanations of the system functionalities including initial application, RFIs, submitting a modification, search and download options etc.


Agenda

Day 1

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

Day 2

  • Workload management - create, submit initial application, respond to Request For Information (RFI)

Day 3

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

Day 4

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

Contact us


Questions to course registration?

Send Email
+41 61 225 51 51


Agenda and Logistics

Send Email
+41 61 225 51 51