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Our services


Our experience

VALUE OUTCOMES provide EU QPPV services for several marketing authorization holders based in the Czech Republic as well as local contact person services for several MA holders who need local representation in the Czech Republic or Slovakia. Our company will compile a tailor-made pharmacovigilance system for you that satisfies the requirements of both the Czech/Slovakian and European legislature.

 

Pharmacovigilance


We offer comprehensive pharmacovigilance services for both Czech and international marketing authorisation holders.

 

  • -  EU QPPV and deputy EU QPPV services
  • -  Local contact person for the Czech Republic and Slovakia
  • -  Key-ready pharmacovigilance system
  • -  Creation of PSMF/SPS according to GVP requirements and local legislation
  • -  Global literature monitoring
  • -  Monitoring of Czech and Slovak local literature
  • -  Administration of safety database
  • -  Counselling in pharmacovigilance
  • -  Creation of Risk Management Plan (RMP) / custom-made RMP