EU Clinical Trial Regulation: Latest Developments and Upcoming Opportunities, Upcoming Webinar Hosted by Xtalks

In this free webinar, gain insight into the current status of the EU Clinical Trial Regulation after four years. Attendees will learn about EU CTR developments between 2022 and 2026 from a transparency perspective. The featured speakers will discuss the current challenges associated with the EU CTR and CTIS. The speakers will also share insights into the potential impacts of the recently published Biotech Act proposal (December 16, 2025).

TORONTO, May 6, 2026 /PRNewswire/ -- The EU clinical trial landscape has changed significantly since Regulation (EU) No 536/2014 became applicable on January 31, 2022, and sponsors now need a clear view of how the framework is operating in practice and where it may evolve next. This webinar explores the current status of clinical trial regulation in the EU, including experience with Clinical Trial Information System (CTIS), updated transparency expectations and emerging regulatory developments.

Since CTIS launched, nearly 13,000 initial applications have been submitted, giving sponsors substantial experience with the benefits and challenges of a more harmonized system, a centralized submission portal and revised transparency rules. Key guidance materials, including the CTIS Sponsor Handbook and related support resources, continue to be updated, with a further handbook update published in March 2026.

The webinar will examine the European Commission's Biotech Act proposal, published on December 16, 2025, and its potential implications for the future EU clinical trial framework. Topics include reduced assessment timelines, parallel substantial modifications, new trial categories, dossier and Member State concepts, emergency procedures and combined trial pathways through CTIS.

Attendees will gain practical context on current submission and transparency expectations, ongoing operational challenges and potential future opportunities in the evolving clinical trial regulatory environment in the EU.

Register for this webinar to learn how clinical trial regulation is evolving across the EU and what these changes could mean for trial submission, transparency and future planning.

Join Pierre-Frédéric Omnes, Executive Director, TransPerfect Life Sciences; Gabriella Di Matteo, EU CTR Advocacy Lead & Strategic Execution, Pfizer; Scott Feiner, Senior Manager, Trial Disclosure, AbbVie; and Andrea Seidel-Glätzer, Director KKS Network Office, KKS Network, for the live webinar on Thursday, May 28, 2026, at 10am EDT (4pm CEST/EU-Central).

For more information, or to register for this event, visit EU Clinical Trial Regulation: Latest Developments and Upcoming Opportunities.

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