One of the highlights on the agenda is an audience-driven Q&A session on Day 1, Stream A at 5pm, led by Dr. Tonia Jeiter (Associate Director Clinical R&D, Alcon; former Clinical Team Lead at TÜV SÜD), offering practical lessons learned from a notified body perspective on aligning clinical evidence with EU MDR expectations. Drawing on experience from both notified body review and industry execution, the discussion will focus on bridging gaps between reviewer expectations and sponsor realities, and on optimizing clinical trial design and submissions for smoother approvals.

You are invited to submit and upvote questions via Slido by 19 January: Submit your question via Slido (or go to slido.com and enter code # 3184931).

Automating and Enhancing Efficiency through R-Based Solutions

  • Design and implementation of an automated Data Management pipeline that standardizes key processes and reduces manual workload across studies
  • Lessons learned from developing and deploying the Data Management pipeline across multiple clinical studies
  • How automation and reproducible pipelines are shaping the future of Data Management and Clinical Data Science