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.