Unlocking the EU Market: Cost-Effective Strategies for Regulatory & Clinical Success

An exclusive session on how to design efficient clinical trials through careful budget planning and regulatory guidance for optimal resource allocation, incorporating both strategic designs and tactical monitoring approaches. 

🔍 You will learn how to: 

✅  Engage with EMA early: Use ITF, Scientific Advice, and ODD for regulatory alignment and optimized trial design   
✅  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   
✅  Optimize resources: Utilize SME Office for fee reductions and regulatory support 
✅ Align clinical & financial goals: Incorporate early regulatory feedback to ensure cost predictability and avoid mid-trial redesigns