Invitation til EMAs Organisation Management Service (OMS) Trouble Shooting Sessions for CTIS brugere

30. august 2022

Ved ansøgning om tilladelse til kliniske forsøg med lægemidler under Forordning om kliniske forsøg med humanmedicinske lægemidler (EU) Nr. 536/2014 (clinical trials regulation - CTR), skal sponsor være registreret i EMAs system til registrering af organisationer (OMS=Organizational Management Service”). EMA inviterer nu til online trouble-shooting session hvor sponsorer og forsøgssites har mulighed for at stille spørgsmål (inden eventet, se tabel) til organisering og forsøgssiteregistrering i OMS. Se invitationen nedenfor (kun på engelsk):

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:

Event Date

Due date for questions

Event page link

Time(one hour)

22 September 2022

15 September 2022

Event page

14:00 – 15:00

19 October 2022

12 October 2022

Event page

14:00 – 15:00

24 November 2022

17 November 2022

Event page

14:00 – 15:00

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 15th of September 2022 COB.

Best regards,

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