Be ready for EU CTR: Strategy, Systems and Lessons Learned

Description: The European Union Clinical Trial Regulation (EU CTR) 536/2014 is the new set-up replacing the EU Clinical Trial Directive (EU CTD) 2001/20/EC and aims to simplify and harmonize procedures for the authorization, assessment, and supervision of clinical trials in the EU. The EU CTR was published on 16 April 2014, and implemented on 31 January 2022 with a 3-year transition period for ongoing trials.
The EU CTR allows sponsors to make one clinical trial application for all EU Member States (MS) intended to participate in a trial, via a centralized portal, the Clinical Trial Information System (CTIS).
Sponsors, Contract Research Organizations (CROs), Applicants and Authorities have been getting prepared for EU CTR, but adjustments had to be made while various stakeholder navigate the new requirements including processes, CTIS and MS Requests for Information.
This session discusses the strategic steps to be taken when implementing the EU CTR, the associated systems and tools required and CTIS alignment. We will discuss resources and training, including SOP updates and Job Aids. Creation of workstreams and cross departmental engagement is crucial, and communication is key. Document requirements and submission strategies will be evaluated, and lessons learned shared. There will be a space for the audience to share their own lessons learned, issues, and tactics for mitigation. In groups, there will be an exercise to produce one EU CTR implementation plan. In the afternoon, examples on how to prepare for the different steps, the taken strategies, lessons learned, and options will be presented.
Robust, proactive communication and planning with regards to the timely availability of submission ready documentation is significant. But making sure that the right systems and resources are available is fundamental. There will be time to discuss the bottle neck situations, countries requests, sensitive matters, and options.

08:00-08:30 Welcome and Workshop Introduction: Carla Gomes
08:30-08:45 Background and Legislation: Carla Gomes
08:45-10:30 What does a company/authority needs to evaluate upfront
10:30-11:00 Refreshment Break
11:00-12:00 Group Exercise; case studies
12:00-13:00 Lunch
13:00-14:00 Presentation of the Case Scenarios
14:00:14:30 Future State – Challenges and keeping on top of the evolving landscape (all presenters)
14:30-15:00 Refreshment Break
15:00-15:45 Panel discussion
15:45-16:00 Review of the Day: Tying It All Together

16:00 pm Adjourn