This is the twelfth 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:

• development support offering for programme-specific evidence planning, including provision of scientific advice on paediatric developments and piloting of scientific advice on clinical trial design;
• the implementation of the new fee regulation;
• completion of onboarding of R&D processes onto the IRIS platform;
• EMA survey focusing on early engagement meetings that foster innovation;
• evidence planning for combination developments comprising of medicinal products with medical devices and/or companion diagnostics;
• action plan to future-proofing the qualification of novel methodologies