4 January, 2021

NEWS – New PrimeVigilance Learning 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 Brexit’s impact on EU and UK pharmacovigilance processes, highlighting the challenges for the Pharmaceutical Industry and the critical requirements that could arise.  


This webinar will run in 2 sessions:

Session 1: 28 January, 10am EST / 3pm GMT / 4pm CET
Session 2: 28 January, 2pm EST / 7pm GMT / 8pm CET

Key learnings include:

Overview of the new pharmacovigilance post Brexit regulation  
•    What are the applicable impacts within the EU for the global pharma company
               • UK QPPV
               • UK PSMF
               • PV Procedures
               • Submission
               • Registering to make submissions to MHRA
•    How to maintain consistency

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, EU QPPV, UK 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, EU QPPV, UK 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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