CRED ERP 25

01/07/2025

External factors – specific to procedural choice

• Source of (and feedback from) scientific advice • National vs CHMP

• Agency expertise and EU influence

• Availability/resource to act as RMS

Willingness/enthusiasm

•

Adherence to timelines

•

The Organisation for Professionals in Regulatory Affairs

15

Reaching a decision on route

• Understand how decisions are made in your Company • Project team • Steering groups • Senior management buy-in • Timelines

• Know and influence key stakeholders

The Organisation for Professionals in Regulatory Affairs

16

8