Clinical Trials Information System (CTIS) bitesize talk: Annual safety report (ASR) new safety module

EventHumanClinical trials

Date

, -

Location

Online
European Medicines Agency, Amsterdam, the Netherlands
Live broadcast

Event summary

CTIS is the single entry point for clinical trial authorisation and supervision in the European Union (EU) and European Economic Area (EEA) under the Clinical Trials Regulation (Regulation (EU) No 536/2014).

Join this CTIS Bitesize Talk to learn how to use the new ASR module, which will become the mandatory channel for submitting and managing ASRs from go-live. The session will help users prepare for the transition and understand the key changes introduced by the new module.

During the session, we will:

  • Introduce the new ASR module and its main functionalities.
  • Demonstrate how to submit and manage ASRs in CTIS.
  • Explain key changes and improvements compared with current processes.
  • Share practical tips to support a smooth transition at go-live.
  • Answer questions and help users prepare for effective use of the new ASR module.

We will also explain the new process for accessing the CTIS training environment and answer related questions.

We encourage all relevant stakeholders to attend and take advantage of this opportunity to prepare for implementation.

How to join

The event will be broadcast live on EMA’s website. No registration is required to watch the live broadcast.

Please note that EMA does not provide certificates of attendance for this event.

Who should attend

The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs), and academic organisations.

Prepare for the session

To get the most from the session, sponsors are encouraged to review the available guidance beforehand:

After the event

A recording of the event will be published after the session. Please note that processing and publication can take up to 60 days. 

To receive updates on the availability of CTIS event recordings, subscribe to the clinical trials newsletter.

Live broadcast - 13:00 - 14:30 (CEST)

Video quality

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Live participation via Slido

We encourage participants to submit questions on sponsor preparedness before the webinar using Slido code #bt23jul. 

Speakers will answer the most popular questions during the panel session.

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