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.

• Date:
  Wednesday, 17 June 2026 , 12:30 - 17:30 Amsterdam time (CEST)
• 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.

Documents

Agenda - Clinical trials information system information day webinar

Presentation - Updates on CTIS programme (O.Bueno, EMA)

Presentation - CTIS Progress: Sponsors’ perspective (G.Di Matteo)

Presentation - CTIS Progress: CRO perspective (L.fitzgerald)

Presentation - CTIS Progress: Non-commercial sponsor perspective (J.Stans)

Presentation - FAST-EU update (S.Strasser)

Presentation - COMBINE Project 1 ‘All-in-one’ Coordinated Assessment Pilot update (C.Temple)

Presentation - Clinical Trials Coordination Group (CTCG) FAQ (A.Bonertz)

Presentation - New rules on translations of patient-facing documents; New template on recruitment and informed consent procedure (M.Al)

Presentation - Commission proposal for an European Biotech Act (E.Szepessy)

Presentation - ICH M11 - Tools for clinical protocols (N.Manent)

Presentation - Safety MVP: Progress update, ASR key changes & upcoming events (M.Sultani)

Presentation - CTIS Service Desk and tips for the users reporting issues (G.Varricchio)

Presentation - New ways of accessing CTIS training environment (O.Ademi)

Presentation - ACT EU priority action on the support for non-commercial sponsors (G.Capone)

Presentation - ACT EU Pilots on consolidated advice in clinical trials (M.Sarra)