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About This Webinar

In this new webinar, our expert speakers Dr. Marcela Fialova and Dr. Jana Hyankova will give their insight into Covid-19’s impact on the EU and the UK pharmacovigilance processes, highlighting the challenges that the Pharmaceutical Industry has had to face and how they adapted.

Agenda
  • Impacts of the COVID-19 pandemic for global pharma companies
  • Updates of EU PV legislation with respect to COVID-19
  • 1. COVID-19 terms to MedDRA
  • 2. Pharmacovigilance activities with respect to COVID-19 vaccines (RMP, Periodic Safety Report, Signal Management, etc.)
  • Followed by a Q&A session
Language: English
Who can attend? Anyone with the event link can attend
Featured Presenters
Webinar hosting presenter
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. She has broad experience from many pharmacovigilance areas (e.g., risk management, PV systems, medical writing) and currently acts as EU/UK QPPV for several clients.
Webinar hosting presenter
PrimeVigilance, Director, EU QPPV, UK QPPV
Jana is an expert in pharmacovigilance with more than 15 years of working experience from several global pharma companies. She joined PrimeVigilance in 2014 and she currently holds the position of PV Director. She serves as EU QPPV for several clients and conducts PV audits as requested by clients.
Webinar hosting presenter
WE HELP EMERGING AND ESTABLISHED COMPANIES MEET THEIR REGULATORY OBLIGATIONS.
PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders and leaders have an unrivaled reputation in the sector with a network of expert associates across the world. These include former senior regulators and consultants with extensive industry experience, especially with marketed products.
https://primevigilance.com/
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