Pharmacovigilance

Ivowen Limited provides a range of pharmacovigilance services for marketing authorisation holders such as:

  • Act as a QPPV (Qualified Person Responsible for Pharmacovigilance)
  • Register your company with EudraVigilance
  • Processing of ICSRs (Individual Case Safety Reports)
  • Reporting via EudraVigilance
  • Literature screening and review
  • Preparation and maintenance of Risk Management Plans (RMPs)
  • Preparation of PSURs (Periodic Safety Update Reports)
  • Signal Detection and evaluation
  • Preparation and maintenance of the Pharmacovigilance System Master File (PSMF)

 

 

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