PSMF Training Course with Marcela Fialova


iVigee COO to co-deliver PSMF training for DIA.
The Drug Information Association 2019s PSMF training course, is being co-delivered by pharmacovigilance expert and iVigee COO Marcela Fialova on November 2nd & 3rd.

Marcela is an experienced PV professional with extensive expertise in the setup, use, and management of Pharmacovigilance System Master Files (PSMFs). She will be sharing her knowledge and best practices about practical PSMF management.

The course is designed around the following to give insights, guidance, and hands-on training:

  • GVP Module II 2013 Pharmacovigilance System Master File (rev. 2)
  • The creation, maintenance, and management of a PSMF
  • A practical exercise on drafting a PSMF
  • The PSMF as a quality document
  • Regulatory expectations for the PSMF, including the UK PSMF
  • A practical exercise on the PSMF after an inspection

You can register for a remaining seat at

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