CTIS lecture at the Master G. Benzi – University of Pavia

On October 13, Massimo Zaninelli held the lecture Introduction to EMA Clinical Trial Information System (CTIS) at the two-year Master on Regulatory Discipline “G. Benzi” – University of Pavia.

CTIS serves to implement EU pharmaceutical law in the Clinical Trials Regulation (Regulation (EU) No 536/2014) and supports the flow of information between clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) countries and the European Commission. The system went live with a searchable public website on January 31 2022 and is currently transitioning from the former EudraCT, ending on January 30, 2025.The lecture dealt with the following topics:

  • Background
  • New concepts in Clinical Trial Information System (CTIS)
  • Transition from the Directive to the Regulation
  • Overview of the sponsor workspace
  • Management of users and organisations in CTIS
  • How CTIS Clinical Trial Application process works
  • Revised CTIS Transparency Rules.