Pharmacovigilance (PV) & Product Safety

  • Changing regulation and increasing litigation is increasing the focus on pharmacovigilance (PV), general drug safety and clear information for patients.
  • Long-standing safety documentation is being overhauled to more clearly present the benefit-risk profile of treatments and new pharmacovigilance requirements are appearing as regulators seek to keep patients better informed.
  • Periodic Safety Update Reports (PSURs) have taken on a new format – PBRER (Periodic Benefit-Risk Evaluation Report) and the Development Safety Update Report (DSUR) replaces the old European ASR (Annual Safety Report) and the United States IND Annual Report.
  • Risk Management Plans (RMPs), mandatory for all European drug submissions since 2012, must also (more recently) contain a Summary of the RMP (Part VI) – a presentation of the drug’s risks in language which patients can understand.
  • We can consult in helping you to assess your needs and prepare the documents you will need. Trilogy has the experience to cover the rigorous pharmacovigilance reporting required.
  • Our experience in presenting both safety data and drug benefits in clear, accessible and patient-friendly language offers you the opportunity to take one more burden off your mind. We also work with an independent physician, who can provide any assessment advice you may need.