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Medicine

Clinical Trials Information System (CTIS) sponsor end user training programme - October 2023

EMA offers a virtual training programme, organised by DIA, to support sponsor user preparedness for the new Clinical Trials Information System and the new way of submitting a clinical trial application and managing the life cycle of a clinical trial in the European Union (EU) and European Economic Area (EEA).

A hands-on approach is taken to explaining and demonstrating the functionalities of the system, such as user management, how to submit an initial application as well as modifications, both substantial and non-substantial. Also, how to manage the life cycle of a Clinical Trial, how to apply Deferral rules and respond to a Request for Information (RFI) will be addressed.

A blended learning approach is being used, offering components on-demand, self-paced and live virtual.

This training programme is open to sponsor users of the new CTIS: commercial and non-commercial sponsors as well as Contract Research Organisations (CROs).

Section I - These topics are offered on demand in a format of a recording which preferably should be watched before joining the live course:

Section II - These topics are offered in a live virtual course:

Interested sponsors can register for the November 2023 sponsor user training course

When

10 Oct 2023 @ 02:05 pm

13 Oct 2023 @ 02:05 pm

Duration: 3 days

Timezone: GMT +2:00


Where

Online Webinar


Language

Englishen


Source:

EMA

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