Clinical Trials Information System (CTIS): Information day

The Clinical Trials Information System (CTIS) Info Day provides a comprehensive update on the CTIS, including progress made, upcoming priorities, and key legal and regulatory developments affecting CTIS.
EventHumanCorporateClinical trials

Date

, -

Location

Online
European Medicines Agency, Amsterdam, the Netherlands
Live broadcast

Event summary

The event aims to strengthen understanding of the Clinical Trials Regulation (CTR), promote best practices, and gather stakeholder input to support effective implementation of the CTR and continuous system improvement.

Programme overview:

  • CTIS Roadmap progress, including completed milestones, ongoing work, and upcoming priorities;
  • implementation updates from Member States and sponsors, reflecting CTCG and CTAG perspectives;
  • new support materials, such as the Sponsor Handbook and updated Sponsor FAQs;
  • practical aspects of CTIS use, including:
    • ServiceNow support,
    • frequently asked questions,
    • common errors and how to avoid them.

The CTIS Info Day also highlights targeted support for non commercial sponsors, share key findings from recent reports, and discuss relevant regulatory developments, including the Biotech Act, the ICH M11 template, and EU pilot initiatives such as Fast EU and combined procedures. 

Panel discussions and stakeholder exchanges focus on what is working well and where challenges remain. Structured feedback collected during the event informs future improvements, change management activities, and continuous optimisation of CTIS.

Audience

This EMA-hosted webinar is open to all sponsor organisations, including pharmaceutical companies, contract research organisations (CROs), small and medium-sized enterprises (SMEs), and academic institutions.

Live participation via Slido

Participants are encouraged to submit questions related to CTIS use, implementation, and sponsor preparedness in advance of the webinar through Slido (code:#CTISInfoDay2026). 

The most popular questions submitted in advance of the event will be answered by speakers during the panel session. Please submit your questions by 5 June 2026, 12:00 noon.

Post event feedback survey

Attendees are invited to fill out a short feedback survey via Slido that is available after the event.

No certificates of attendance are issued for this event.

The event is broadcast live. A video recording is made available after the event. Processing and publication of the video recording typically take up to 60 days.

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