CRED 8 Presentations

01/07/2024

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