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Global Forum for Qualified Persons for Pharmacovigilance (QPPV)

15th Anniversary


Session 2: Pharmacovigilance Learnings From Covid-19 – The Pandemic And The Vaccine

Session Chair(s)

Anja  Van Haren, MSc

Anja Van Haren, MSc

  • EudraVigilance Coordinator
  • Medicines Evaluation Board (MEB), Netherlands
Magnus  Ysander, MD

Magnus Ysander, MD

  • EU & UK QPPV & Head Pharmacovigilance Excellence
  • AstraZeneca, Sweden
In the current era of the COVID-19 pandemic, the world has never been more interested in pharmacovigilance. Accelerated regulatory approval pathways for COVID-19 vaccines and treatments merits even more rigorous postmarketing surveillance. This session will discuss how the pharmacovigilance network is challenged by for example increased case volumes, innovative signaling methods and new regulatory requirements in a global setting.

Speaker(s)

Phil  Tregunno

The UK Vaccination Program – Preparations and Experience from a Regulatory Authority Perspective

Phil Tregunno

  • Head of Vigilance Operations, Safety & Surveillance
  • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Magnus  Ysander, MD

A Matter of Volume - Experience from an Industry Perspective

Magnus Ysander, MD

  • EU & UK QPPV & Head Pharmacovigilance Excellence
  • AstraZeneca, Sweden
Sabine  Straus, MD, PhD, MSc

PRAC Considerations

Sabine Straus, MD, PhD, MSc

  • PRAC Chair, Staff Member
  • Medicines Evaluation Board (MEB), Netherlands
Vicki  Edwards

Business Continuity in the context of COVID-19 Pandemic

Vicki Edwards

  • Vice President, Pharmacovigilance Excellence and International QPPV
  • AbbVie, Inc., United Kingdom
Barbara  De Bernardi, MD

Panel Discussion with Q&A

Barbara De Bernardi, MD

  • EUQPPV Vice President - Head of Global QPPV Office
  • Pfizer S.r.l., Italy