The way clinical trials are conducted in the EU will undergo a major change when the Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS).
CTIS will contain the centralised EU portal and database for clinical trials foreseen by the Regulation and will be used by clinical trial sponsors as a single-entry point in the EU to obtain approval for clinical trials based on applications and for monitoring clinical trials during their life cycle, including the submission of summary of results.
To facilitate preparedness for use of CTIS (Clinical Trials Information System-the tool that will centralise the regulatory submission for multinational clinical trials in Europe) the European Medicines Agency has developed a training programme to provide future CTIS users with the skills and knowledge to successfully use CTIS into their business.
There are two training sessions targeted to SMEs and academia trial sponsors:
Day 1 on 22nd February 2021 will present CTIS access management, user management and different roles in CTIS.
Day 2 on 4th March 2021 will focus on CTIS functionalities – how to submit and manage a clinical trial application. Transparency of reporting of results will also be presented on Day 2.
The webinar will include presentations by speakers from EMA system experts and presenters from SME and academic institutions, demonstration of the system, and opportunities for questions and answers. The webinar will be recorded and published for future perusal.
To express your initial interest for this training, please complete the expression of interest questions by the 29th of January 2021.
More information on the training event can be found here