CRED NPM

05/11/2024

Internal

Lessons learnt for a successful switch

Early engagement with HA (Scientific Advice meetings)

Collaboration & persistence with HA

High quality dossier to ensure 1st time right application

Robust safety data/RWE

Strong labelling & Brand name

Competitor analysis

The Organisation for Professionals in Regulatory Affairs

17

Internal

Thank you for your attention

The Organisation for Professionals in Regulatory Affairs

18

9