Eight industry stakeholder platform on research and development support

This is the eighth 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 strengthening the ecosystem of engagement platforms for evidence planning, continuous improvement of paediatric procedures, patient-centric development, collaboration at the regulatory/HTA interface, follow-up from the 5-year report on the experience with the PRIME scheme, actions following the “Orphan Maintenance Assessment Report” survey as well as progress with the implementation of the companion diagnostics framework.