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About This Webinar

This webinar will focus on the activities that should be carried out for the establishment and maintenance of a pharmacovigilance system for marketing authorization holders based on quality standards that are detailed in Good Pharmacovigilance Practices. It will also describe the role of the Qualified Person Responsible for Pharmacovigilance in the EU (EU QPPV) as the crucial role in the performance of these activities within the marketing authorization holder’s pharmacovigilance system.

You will get insight into the regulatory framework as well as guidance on the structures and processes of a pharmacovigilance system.

  • Regulatory framework
  • Overall quality objectives for pharmacovigilance
  • Compliance management by marketing authorization holders / Specific quality system procedures and processes
  • Processes to monitor the performance and effectiveness of a pharmacovigilance system and its quality system
  • Role and responsibilities of the EU QPPV
  • Q&A Session
Language: English
Who can attend? Anyone with the event link can attend
Featured Presenters
Webinar hosting presenter
Senior PV Director, EU QPPV, UK QPPV
Jana Hyankova is an expert on pharmacovigilance with more than 15 years of working experience from several global pharma companies. Jana joined PrimeVigilance (former PharmInvent) in 2014 and currently holds the position of Senior PV Director in the QPPV Department. She serves as EU QPPV and UK QPPV for several clients and conducts PV audits as requested by clients. Prior to joining PrimeVigilance, she held managerial pharmacovigilance roles at Bristol Myers Squibb and PharmaSwiss SA after the acquisition of the company Valeant Pharmaceutical International. Jana has gained her medical education at Charles University in Prague. Outside of PrimeVigilance, Jana is chairing RQA Pharmacovigilance Committee and is also an active lecturer of the RQA, PIPA, ISoP, and Conforum.
Webinar hosting presenter
Strategic Advisor, EU QPPV, UK QPPV
Elena joined PrimeVigilance in 2021 after 14 years of working in different pharma companies. She currently holds the position of Strategic Advisor in the QPPV Department, acting as EU QPPV and UK QPPV for several clients. She has a degree in Pharmacy from the Universidad Complutense in Madrid and a master’s degree in Pharmaceutical Industry. During her professional career, she has specialized in the field of product’s safety, focusing on Human Pharmacovigilance but also Veterinary Pharmacovigilance and Cosmetovigilance. She is an active member of the Spanish Association of Pharmacists of the Pharmaceutical industry and an active lecturer in different master’s degrees.
Webinar hosting presenter
PrimeVigilance, an Ergomed plc company, was set up by former Pharmacovigilance Regulators in 2008. We have grown to become the leading Pharmacovigilance specialist company, delivering global solutions for both clinical safety and post-marketing pharmacovigilance, as well as medical information from our offices. Having successfully delivered Pharmacovigilance (PV) and Medical Information (MI) services for over 13 years, our experience enables us to offer a comprehensive, top quality, cost-effective, and innovative safety solution. Our flexible approach, tailor-made to work with clients, allows us to deliver the services that meet your clinical and post-marketing needs. From its operational hubs based in Europe, the USA, and in Japan. PrimeVigilance manages a global Pharmacovigilance system with a choice of leading drug safety databases, stretching to more than 100 countries.
Contact: info@primevigilance.com
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