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.
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