Search results with tag "Periodic safety update"

Monitoring of medical literature and the entry of ... - Europa

parallel for Periodic Safety Update Reports (PSURs) and/or signal detection purposes? The reporting modalities regarding suspected non -serious adverse reactions are described in GVP module VI, chapter VI.C.4 "Reporting modalities". Based on these reporting modalities, only individual cases of suspected non -serious adverse reactions

  Update, Safety, Periodic, Periodic safety update