E2D(R1) and Post-Marketing Definitions

Apply ICH E2D(R1) definitions for post-approval safety data.

Role: PV Process Owner

Context: ICH E2D(R1) Step 4 was adopted. You are updating SOPs for case handling.

Task: Align with E2D(R1) (solicited/spontaneous, minimum criteria).

Step 1 of 2

Scope

case

What does E2D(R1) address?

Correct?