24 Sep 2020
PrimeVigilance Free Learning Webinar: The Importance of a Full Understanding of the Pharmacovigilance System Master File (PSMF)

We are pleased to announce that registration is now open for PrimeVigilance’s free webinar “The Importance of a Full Understanding of the Pharmacovigilance System Master File (PSMF)” taking place on 15 October, 2020.

This webinar aims for our experts to present and provide our listeners with a good understanding of the Pharmacovigilance System Master File (PSMF) within and outside the EU, highlighting the challenges for the Pharmaceutical Industry and the critical requirements that could arise.

Key learnings include:
• Overview of the different aspects of PSMF set-up and maintenance in a global pharma company
• What types of PSMFs are applicable within the EU
• Descriptions of PV systems in non-EU regions
• How to maintain consistency between individual PSMFs/Descriptions of PV systems required in respective regions

You will have the opportunity to ask our experts any questions you may have.



Session 1: 15 October, 10am EDT / 3pm BST / 4pm CET  Register here

Session 2: 15 October, 2pm EDT / 7pm BST / 8pm CET  Register here



Marcela Fialova, MD – PrimeVigilance, Senior Director, EEA QPPV

Marcela is a pharmacovigilance professional with more than 20 years of experience in the pharmaceutical business. She has spent the majority of this time in pharmacovigilance, as well as quality assurance, auditing and regulatory affairs. Marcela´s many years of experience have given her a profound and expansive understanding of all pharmacovigilance areas in both generic and innovative pharma. Marcela studied Medicine at Charles University in Prague and holds a Doctorate in Medicine (MD) and a Baccalaureate in Healthcare Management from the University of Economics (Bc). Today Marcela is the deputy Head of PV Operations at PrimeVigilance, while simultaneously operating as EU QPPV.


Jana Hyankova, MD – PrimeVigilance, Director, EEA QPPV

Jana is an expert on pharmacovigilance, with more than 15 years of experience at several global pharma companies. Jana joined PrimeVigilance in 2014, and she currently holds the position of Director, EEA QPPV. Jana serves as EU QPPV for several clients and conducts PV audits as requested by clients. Jana gained her medical education at Charles University in Prague and worked eight years at the Institute for Clinical and Experimental Medicine as a Researcher in the IT Department, focusing on medical databases, Czech and EU financial projects and hospital IT system development. Outside of PrimeVigilance, Jana is an active lecturer at Conforum, Institute of Pharmacovigilance and the Research Quality Association (RQA). Jana also chairs the RQA Pharmacovigilance Committee.