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EMA Clinical Trial Information System (CTIS) Information Day

The focus of this live virtual CTIS information day is to share practical advice and best practices with regard to transitioning clinical trials, timelines in CTIS, system metrics, insights of clinical trial assessments as well as user management.


The Clinical Trials Information System (CTIS) is the single-entry point for clinical trials authorisation and supervision in the EEA. This includes a single clinical trial application dossier, covering clinical trial applications submitted to EU/EEA Member States, including submission to National Competent Authorities (NCAs) and Ethics committees (ECs) and registration of the clinical trial in a public register; all in one integrated submission. CTIS provides harmonised and simplified end-to-end electronic application procedures over the lifecycle of clinical trials across the EU/EEA.

The focus of this virtual information day – 9 months after the launch - is to share some practical advice regarding transitioning clinical trials from the Clinical Trials Directive (2001/20/EC) to the Clinical Trial Regulation (536/2014) as well as best practices on user management.

Furthermore, first insights on submissions and assessments of clinical trial applications and system metrics on usage of CTIS will be presented. It will also outline the importance of understanding timelines in CTIS, as will upcoming training opportunities and events.

Ample time is foreseen for Q&A. The faculty invites participants to submit related questions by 17 October 2022 latest to


Featured topics

  • Transition period from the Clinical Trials Directive (2001/20/EC) to the Clinical Trial Regulation – regulatory and practical aspects
  • Insights of clinical trial application assessments
  • Timelines in CTIS
  • Best practices on user management
  • CTIS system metrics
  • Upcoming training and event opportunities


Who should attend?

This EMA CTIS Virtual Information Day is aimed at CTIS users from:

  • Pharmaceutical companies
  • Small and medium sized enterprises (SMEs)
  • Academic organisations
  • Contract Research Organisations (CROs)
  • Member State NCAs


Program Committee

  • Marianne  Lunzer, DrMed
    Marianne Lunzer, DrMed Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
    AGES, Austria
  • Noemie  Manent, PharmD
    Noemie Manent, PharmD TDA-TCS Operations Workstream Lead
    European Medicines Agency, Netherlands
  • Pieter  Vankeerberghen
    Pieter Vankeerberghen Head of Clinical Trials
    European Medicines Agency, Netherlands
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Contact us

Agenda Questions

Send Email
+41 61 225 51 51

Registration Questions

Send Email
+41 61 225 51 51