Clinical Trials Information System (CTIS) Webinar - 9 months on and going forward - November 2022

Date: 16/11/2022
Location: Online, 13:30 - 17:30 Amsterdam time (CET)

Event summary

The Clinical Trials Information System (CTIS) is the single-entry point for clinical trials authorisation and supervision in the European Economic Area (EEA). This includes an integrated 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. 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 CTIS 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.

The event will feature first insights from assessments of clinical trial applications and system metrics on usage of CTIS. It will also outline the importance of understanding timelines in CTIS, as will upcoming training opportunities and events. There will be time for questions and answers.

The faculty invites participants to submit relevant questions by 17 October 2022 at the latest to

Key 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
  • User Management best practice
  • CTIS System Metrics
  • Upcoming training and event opportunities

Target audiences

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

  • Pharmaceutical companies
  • Small and medium-sized enterprises
  • Academic institutions
  • Contract research organisations
  • Member State 
  • Ethics committee members

Video recording

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