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Pregnancy Prevention Plan (or Programme, PPP)

  • PPPs are documents laying out a set of interventions intended to reduce the likelihood of pregnancy during treatment with a medicinal product with known or potential teratogenic effects.
  • The term Pregnancy Prevention Plan (PPP) is used in the USA. The equivalent document in the EU is termed a Pregnancy Prevention Programme (PPP).
  • The PPP forms part of the overall Risk Evaluation and Mitigation Strategies (REMS) or Risk Management Plan (RMP), as is defined by guidelines covering these documents, specifically in the EU by EMA’s guidelines on pharmacovigilance practices (GVP), module XVI.
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