All ongoing trials approved under the previous regulatory framework (EU Clinical Trial Directive 2001/20/EC) in the scope of the EU CTR will have to end or transition to comply with the new regulation by January 31, 2025.
TORONTO (PRWEB) February 27, 2023
As the most significant change in the European Union clinical trial legislative ecosystem in 20 years, the European Union Clinical Trial Regulation 536/2014 (EU CTR) went live on January 31, 2022. The first-year transition period has now ended, and from January 31, 2023, EU Clinical Trial Regulation became compulsory for all new interventional clinical trials of investigational medicinal products. All ongoing trials approved under the previous regulatory framework (EU Clinical Trial Directive 2001/20/EC) in the scope of the EU CTR will have to end or transition to comply with the new regulation by January 31, 2025.
In that context, sponsors and clinical trial applicants need to ensure both internal readiness of their organization as well as expansion of EU CTR for new and ongoing studies (at least for those not ended by early 2025) in order to prepare for its multiple operational impacts.
For optimal EU CTR readiness, the following points must be considered: Assessing EU CTR’s impact on the organization and planning readiness strategies based on the development portfolio; Managing submission activities using the new EU Portal, Clinical Trial Information System (CTIS), while accounting for evolving transparency rules; Piloting studies under EU CTR to confirm/adjust implementation strategies as needed, and more.
With over three years of engagement in the development of the Clinical Trial Information System as Product Owner for the sponsor and academia sponsor, the featured speaker will take the opportunity of this first milestone in the EU Clinical Trial Regulation transition to review current and future challenges and opportunities related to EU Clinical Trial Regulation implementation both on a readiness and operational execution standpoint for industry sponsors of clinical trials involving one or more countries in EU/EEA.
Join the featured speakers Gaby Di Matteo, Director, Clinical Trial Regulatory Operations Team Manager, Pfizer Global Regulatory Sciences; Samia Dridi, Clinical Trial Regulatory Lead, Roche; Pierre-Frédéric Omnes, Executive Director, TransPerfect Life Sciences; and Andrea Seidel-Glaetzer, MA, RN, Head of Project Management, Coordination Centre For Clinical Trials Heidelberg (KKS), Germany, for the live webinar on Tuesday, March 7, 2023, at 11am EST (5pm CET/EU-Central).
For more information, or to register for this event, visit Navigating the EU Clinical Trial Regulation Complexities: Current Challenges and Opportunities.
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