Day 1 – Tuesday, February 25, 2025Tuesday, 25 February 2025 - ET (Eastern Time, GMT-05:00)

Join our thought-provoking opening session with discussion on:

• The attractiveness of the European Union for clinical research after 3 years from the launch of ACT-EU: the Draghi report on competitiveness and industry's concerns
• The implementation of the Clinical Trial Regulation and its interplay with other Union and national laws (e.g. GDPR, AI act, EHDS Regulation, related EU and national guidance)
• Transparency obligations in the CTIS data base vs. protection of sponsors' IP rights

Dive into the latest shifts in Policy 70 and discover how sponsor companies are adapting to these pivotal changes. Join us for an in-depth exploration of the key updates and what they mean for your organization moving forward.

• Clarify recent updates to submissions and results
• Dive into best practices for tracking intermediate data analysis results.

Explore the evolution of Layperson Synopses (LPS) and insights into best practices in making complex scientific information accessible to a broader audience. The presenters will share an analysis of recent trends and key insights based on a review of LPS public postings to EU CTIS.

• Explore how sharing clinical trial data benefits participants, accelerates drug development, and maximizes investments.
• Dive into a case study showcasing how compliant sharing of Individual Patient Data (IPD) can address challenges in neglected tropical diseases.
• Understand how data sharing fosters transparency, supports secondary research, and speeds up medicine development for underserved conditions.
• Discover strategies for balancing data sharing with participant privacy and confidentiality requirements.

Don’t miss our dynamic discussion as Xogene share diverse perspectives on how AI is revolutionizing clinical data transparency and reshaping day-to-day operations across the industry.

Engage in eye-opening discussions and strategies for managing patient facing documents. The conversation will include strategies on disseminating PLS to study participants, and ways to ensure consistency across multiple public facing documents.