Module232025

12/05/2025

Paediatric Regulation as a supportive tool - breaking the (PIP) development silo

Move from ‘product to population’ - science focused discussion

Facilitating Science-Focused Discussions:

• Ensure R&D efforts target the right population based on the mechanism of action.

• Generate robust evidence quickly.

Holistic Approach to Development:

• Integrate efforts across different development areas, considering patient resources in a competitive space.

• Advance only the most promising products towards registration.

9 https://www.ema.europa.eu/en/documents/agenda/agenda-enpr-ema-coordinating-group-networks-meeting-october-2024_en.pdf

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The PIP submission Interaction with the regulators

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