Pharmacovigilance

pharmacovigilance-header

The ultimate goal of pharmacovigilance is to appropriately handle information concerning adverse drug reactions and to protect the public from emerging safety issues throughout a medicine’s lifecycle. Our Qualified Persons for Pharmacovigilance (QPPV) are all suitably qualified. Apart from EU QPPV services for the territory of EEA, we can also offer national support in the countries where the presence of a local QPPV or contact person for pharmacovigilance is mandatory or recommended. These professionals will make sure that as marketing authorisation holder (MAH), you have the appropriate pharmacovigilance system in place (Pharmacovigilance System Master File (PSMF)), will examine the safety profiles of your medicines and will be in contact with the drug authorities on your behalf.

EuDRAcon provides the following pharmacovigilance services:

  • Local and global literature screening
  • EudraVigilance Reporting
  • Pharmacovigilance Training
  • Pharmacovigilance Quality System
  • Audits
  • Risk Management Plan (RMP)
  • Periodic Safety Update Report (PSUR)
  • Development Safety Update Report (DSUR)
  • Periodic Benefit-Risk Evaluation Report (PBRER)
  • Causality Assessment
  • Individual Case Safety Reports (ICSR)