Module 1 2021

25/06/2021

Case Study 3 – PRIME data for benchmarking and advocacy purpose Question Obtain metrics on PRIME designation to support advocacy activities on unmet medical needs and access Notes Requested as part of preparation for an external meeting

Outcome/Application Metrics were quickly accessed and shared and

Tools Internal data, EMA data, vendor data.

The Organisation for Professionals in Regulatory Affairs

15

Shaping regulatory guidance development

The Organisation for Professionals in Regulatory Affairs

16

8