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] |