NEWS – New PrimeVigilance Educational Pharmacovigilance Webinar

In this webinar, our expert speakers Dr. Marcela Fialova and Dr. Jana Hyankova, will aim 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.

This webinar will run in 2 sessions:

Session 1: 15 September, 10am EDT / 3pm BST / 4pm CEST
Session 2: 15 September, 2pm EDT / 7pm BST / 8pm CEST

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

At the end of the webinar, you will have the opportunity to ask our experts any questions you may have.

About our expert speakers:

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. For more information, please visit Marcela’s profile on our website.


Jana Hyankova, MD – PrimeVigilance, Director, EEA QPPV

Jana is an expert in pharmacovigilance, with more than 15 years of experience at several global pharma companies. She has worked at PrimeVigilance since 2014, plus additionally serves as EU QPPV for several clients and conducts PV audits as requested by clients. For more information, please visit Jana’s profile on our website. 

If you have any questions  about our webinar please feel free to contact us 

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