The European Medicines Agency (EMA) is set to host a pivotal event on July 9, 2025, in Amsterdam, focusing on the redesign of the Clinical Trials Information System (CTIS) training materials tailored for sponsor users. This Bitesize Talk aims to introduce the updated Sponsor Handbook, which will replace existing training modules, streamlining the process for various sponsor entities within the European Union (EU) and the European Economic Area (EEA).
Comprehensive Training Overhaul
The redesigned Sponsor Handbook serves as the ultimate guide for sponsor organizations, including pharmaceutical companies, contract research organizations, SMEs, and academic institutions. Effective from July 9, the new handbook will provide detailed instructions and best practices for navigating CTIS, ensuring a unified approach to clinical trial authorization and supervision across the EU. Participants are encouraged to review current CTIS training resources and the online modular training program to maximize their preparedness for the event.
Interactive Participation and Support
The event will feature live broadcasts and interactive sessions via Slido, allowing attendees to submit questions in advance using the designated code. Although registration is not required for live viewing, active participation is encouraged to address common challenges faced by sponsors. Following the event, a video recording will be available to registered users, ensuring that the insights shared can be accessed by a broader audience interested in enhancing their CTIS proficiency.
Key takeaways:
- Introduction of the revised Sponsor Handbook as the primary reference for CTIS users.
- Emphasis on updating and unifying training materials to improve sponsor readiness.
- Opportunities for interactive engagement and personalized support through live Q&A sessions.
- Availability of post-event resources, including video recordings for continued learning.
EMA’s initiative to revamp the CTIS training underscores its commitment to facilitating efficient and standardized clinical trial processes within the EU framework. By providing comprehensive and accessible training materials, the agency aims to empower sponsor organizations with the knowledge and tools necessary to navigate the complexities of clinical trial authorization seamlessly. This move not only enhances regulatory compliance but also fosters a collaborative environment where sponsors can contribute to the advancement of medical research effectively. Sponsors should leverage the available resources and engage actively in the upcoming event to stay ahead in the evolving landscape of clinical trial management.
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