Definition

Interventions intended to prevent or reduce the probability of an adverse reaction occurring or its severity if it does occur.

Example

Risk minimization measures for a teratogenic drug include: contraindication in pregnancy, pregnancy prevention program, contraception requirements, and pregnancy testing protocols.

Regulatory source

EU GVP Module XVI

Common mistakes

Implementing RMMs without a plan to evaluate their effectiveness.

Inspector question

How do you assess the effectiveness of your risk minimization measures?

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