Clinical Trials Information System (CTIS) bitesize talk: Initial clinical trial application

Date: 23/03/2022
Location: Online, 14:00 - 15:30 Amsterdam time (CET)

Event summary

This bitesize talk on CTIS provides an opportunity for sponsors to learn about initial clinical trial applications. It covers:

  •  the data and documents required for an application;
  •  how to create, submit, cancel or withdraw an application.

Sponsors will also have opportunity to ask questions during the event.

CTIS is the business tool of the EU Clinical Trials Regulation (Regulation (EU) No 536/2014) and it acts as a single entry point for clinical trial authorisation and supervision in the European Economic Area.

This event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. EMA cannot provide attendees certificates of attendance for this event.

Prior to attending this event, sponsors are encouraged to consult the CTIS training and support materials, including the CTIS sponsor handbook and Module 10 'Create, submit and withdraw a clinical trial' from the online modular training programme.

Event will be live broadcast and no registration is required for those wishing to follow the live broadcast on EMA’s website.

Attendees are invited to fill out a short feedback survey that will be available after the event through this page.

Post event survey

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