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Table 1 Pharmacovigilance activities for risk management planning

From: Risk Management Plans: reassessment of safety concerns based on Good Pharmacovigilance Practices Module V (Revision 2)—a company experience

Activity

Routine PV activities beyond adverse reaction reporting and signal detectiona

 • TFUQs to obtain structured information on reported suspected adverse reactions of special interest

 • Other forms of routine PV activities

  - Enhanced passive surveillance system (high‐level description)

  - Observed versus expected analyses

  - Cumulative reviews of adverse events of interest

Additional PV activities

 • Non‐clinical studies

 • Clinical trials or non‐interventional studies (e.g., long‐term follow up of patients from the clinical trial population or cohort study to provide additional characterization of the long‐term safety of a product, PASS)

 • Studies/surveys to evaluate the effectiveness of additional RMMs (in accordance with GVP Module XVI; see Table 2) [7]

  1. GVP Good Pharmacovigilance Practices, PASS Postauthorization Safety Study, PV Pharmacovigilance, RMMs Risk Minimization Measures, RMP Risk Management Plan, TFUQs, Targeted Follow-up Questionnaires
  2. aOnly routine PV activities that go beyond adverse reaction reporting and signal detection should be included in the RMP