Invitation to EMA Organisation Management Service (OMS) Trouble Shooting Sessions for CTIS users

Before applying for clinical trials with investigational medicin products under the EU Clinical Trials Regulation no. 536/2014 (EU CTR), sponsors and trial sites have to be registered in EMAs Organizational Management Service (OMS). EMA is now inviting all sponsors and trial sites to online trouble shooting sessions, where they can submit questions in advance (see tabel below) concerning organisation and site registration in OMS. Please see the invitation below:

On Thursday, 22 September 2022 from 14:00 to 15:00 CET, EMA will organise an event to support CTIS users with OMS-related questions. The event will be broadcasted (details of the event page).

This is the third event in the series and aims at clarifying OMS outstanding questions reported by CTIS users and clinical trial sites. EMA is offering this dedicated support to address issues and questions related to registering the organisation and/or location data in OMS for use in CTIS clinical trial applications.

The calendar of the next sessions is shown below:

In preparation for this session, we will capture questions via Slido, until 15 September 2022.

For sponsor users, please use code: #CTISTSSponsor and for Member States users, please use code: #CTISTSMS. Questions will be answered by speakers during the panel session.

We look forward to hearing from you by the 15^th of September 2022 COB.

Best regards,

CT Communication
European Medicines Agency
Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands
+31 (0)88 781 7065