14th industry stakeholder platform on research and development support

• Date:
  Thursday, 03 July 2025, 12:30 - 17:30 Amsterdam time (CEST)
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This is the fourteenth in a series of regular meetings between regulators and representatives of industry stakeholder organisations. It addresses all areas of evidence generation along the medicine’s life-cycle and related to development support activities, such as scientific advice and qualification, as well as specifics for paediatric and orphan medicines. 

This meeting will focus on ongoing and upcoming initiatives to strengthen the scientific advice offering, including scientific advice for paediatric developments, experience with SAWP-CTCG pilots for providing scientific advice, and opportunities to enable scientific dialogue.

Furthermore, experience with the new features of the PRIME scheme will be discussed and the piloting of the product development coordinator for PRIME products introduced.

Another topic is moving the stepwise Paediatric Investigation Plan (sPIP) concept from pilot to regular operations and initiatives for early engagement meetings that foster innovation. Finally, in addition to updates from ongoing focus groups, the establishment of potential alternatives to animal testing in line with the 3Rs principles will be presented.

The event will be live broadcast for internal participants only via TEAMS.

Registration

• Registration by invitation only

Documents

Draft agenda – 14th Industry stakeholder platform on research and development support

Reference Number: EMA/119654/2025