Skip to main content
RAPS Euro Convergence 2025 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Networking Event
Networking Event
Sponsor Presentation
Sponsor Presentation
Ticketed Event
Ticketed Event
Evaluation

Pharmaceuticals

EMA and FDA Programs to Accelerate Innovation in Treating Unmet Medical Needs

Thursday, May 15, 2025
16:45 - 17:45 CEST
Location: Studio 214 + 216 (level 2)
Learning Level: Intermediate
Description: As the demand for innovative therapies to address rare diseases and unmet medical needs continues to grow, navigating the regulatory landscape becomes crucial. This session will feature expert insights from both an EMA representative and industry expert, offering an overview of key programs from the EMA and FDA designed to support and expedite the development of life-changing treatments. From the latest initiatives aimed at speeding up the approval process to strategies for engaging with regulatory bodies, this session will provide valuable guidance for stakeholders looking to accelerate their innovation journey.

Learning Objectives:

  • EMA's key programs like PRIME, ITF, and the Quality Innovation Group designed to support innovative therapies in the EU.
  • FDA initiatives, including Breakthrough therapy designation, START pilot, and Priority review, aimed at fast-tracking treatments for serious conditions and/or rare diseases.
  • Regulatory pathways for expedited approval, including exceptional circumstances and conditional marketing authorizations in the EU and fast-track mechanisms in the US.