Risk Minimization Effectiveness

Design and explain effectiveness evaluation for an aRMM (GVP XVI Addendum II).

Role: Risk Management Lead

Context: Your product has a Pregnancy Prevention Programme. GVP XVI Addendum II requires effectiveness evaluation.

Task: Propose an appropriate evaluation and answer inspector questions.

Step 1 of 2

Evaluation Method

case

You need to evaluate whether the PPP is effective (e.g., prescribers perform pregnancy testing). What is an appropriate approach?

Best option?