Final countdown: How to transition your trials under EU-CTR

There are two sessions available on Tuesday, April 30th. Register for your preferred session using the links below.

Register: Tues, 30 April at 10am BST   Register: Tues, 30 April at 3pm BST

While EU Clinical Trial Regulation 536/2014 (EU-CTR) became mandatory for all new trials last year, sponsors were given additional time to transition existing studies into the Clinical Trial Information System (CTIS) – the data/documents-submission platform required by EU-CTR. Under the new regulation, stakeholders must use CTIS as a single-entry point to submit, evaluate, and authorize clinical trial applications across all 30 countries in the European Economic Area (EEA).

All studies authorized under previous regulation EU-CTD with last patient last visit after 31 January 2025 must be transitioned before this date, otherwise, they will become non-compliant with corrective measures required by Member States. 

Did you know that it can take up to six months to transition a study if harmonization and a substantial amendment are necessary? And with the final deadline less than 10 months away, we urge all sponsors to act now – particularly as thousands of trials must transition during this period and timelines may be extended due to an increase in demand for regulatory resources. 

Join our webinar to hear firsthand experience from Parexel’s regulatory experts who have made more than 250 applications under EU-CTR, including nearly 50 transition submissions. Our EU-CTR readiness can support you in navigating the requirements of this regulatory process. 

What you will learn:

1. The processes and timescales required to meet the EU-CTR trial transition deadline of 31 January 2025 
2. Actions that sponsors should take for a smooth transition process and to mitigate the risk of non-compliance as a result of missing the deadline 
3. Key learnings, insights and tips from regulatory experts with practical experience in how to approach the transition process
4. The opportunity to submit your queries as part of a live Q&A 

Register: Tues, 30 April at 10am BST   Register: Tues, 30 April at 3pm BST

Speakers