Unlocking the EU Market: Cost-Effective Strategies for Regulatory & Clinical Success
April 17, 2025
3:30 (Beijing time)
45 minutes
Registration form
fill out in English
Key take-aways:
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.
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
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 trial: recruitment, endpoints, and budget management for cost-effective execution
Accelerate market access: leverage PRIME, conditional approval, and Adaptive Pathways
Keynote Speakers
Polina Shatrova
Head of Budgets and Proposals, Palleos
Valentyna Starodub
CEO, Starodub B.V.
Dr. Philip Raeth
Managing Director, Palleos
