The Regulation (EU) No 536/2014 establishes that clinical trials in the European Union must be managed through the Clinical Trials Information System (CTIS). The Regulation came into force in January 2022, providing a 3-year transition period until January 2025.
This course provides key guidance for the successful implementation and management of the CTIS portal from the initial clinical trial application throughout its life-cycle, as well as a live demonstration of the main functionalities of the system.
• Introduction to Regulation (EU) 536/2014 and key changes in CT Directive vs CT Regulation
• Transparency
• CTIS user access management
• Initial Clinical Trial Application
• Management of Transitional Clinical Trials
• Update of an initial CTA
• Notifications required during the life-cycle of a clinical trial
• Search, view and download information on clinical trials and clinical trial applications
• Request for Information (RFI) and work-planning, management tools
• Submission of Annual Safety Reports, trial and layperson summary of results
• Demonstration: Simulation of access management and initial CT application
• Clinical Trial Managers and Coordinators
• Regulatory Affairs Specialists
• Pharmaceutical and Biotech Employees
• Academic Researchers
Nuria Garcia Pazos
Regulatory Affairs Senior Consultant
EMA CTIS Subject Matter Expert
Nuria is involved in EMA-led stakeholder meetings and CTIS trainings since 2020. In December 2023, the EMA named her Subject Matter Expert for CTIS with the aim of participating in the continuous development and improvement of the system.
The course is delivered in one 4-hours session from 9:30 a.m to 1:30 p.m
Price: Upon request
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