May 27, 2025

11 am PT | 2 pm EST | 8 pm CET

45 minutes

Key takeaways:

Entering the EU market requires strategic regulatory planning. Early EMA engagement through ITF, Scientific Advice, and ODD optimizes trial design. PRIME, conditional approvals, and SME Office streamline timelines and reduce costs.

Efficient clinical trials need careful budget planning and regulatory guidance for optimal resource allocation, incorporating both strategic designs and tactical monitoring approach.

Engage with EMA early: Use ITF, Scientific Advice, and ODD for regulatory alignment and optimized trial design.

Align clinical/financial goals: Incorporate early regulatory feedback to ensure cost predictability and avoid mid-trial redesigns

Optimize resources: Utilize SME Office for fee reductions and regulatory support.

Design efficient trials: Plan recruitment, endpoints, and budget management for cost-effective execution.

Accelerate market access: Leverage PRIME, conditional approval, and Adaptive Pathways to reduce development timelines.

Keynote Speakers

Polina Shatrova

Head of Budgets and Proposals, Palleos

Valentyna Starodub

CEO, Starodub B.V.

Dr. Philip Raeth

Managing Director, Palleos

Organisers