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Session 2: Pharmacovigilance Learnings From Covid-19 – The Pandemic And The Vaccine
Session Chair(s)
Anja Van Haren, MSc
Eudravigilance coordinator, Medicines Evaluation Board (MEB), Netherlands
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)
The UK Vaccination Program – Preparations and Experience from a Regulatory Authority Perspective
Phil Tregunno
Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
A Matter of Volume - Experience from an Industry Perspective
Magnus Ysander, MD
EU & UK QPPV & Head Pharmacovigilance Excellence, AstraZeneca, Sweden
PRAC Considerations
Sabine Straus, MD, PhD, MSc
Former PRAC Chair, Medicines Evaluation Board (MEB), Netherlands
Business Continuity in the context of COVID-19 Pandemic
Vicki Edwards, RPh
Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom
Panel Discussion with Q&A
Barbara De Bernardi, MD
EUQPPV Vice President - Head of Global QPPV Office, Pfizer S.r.l., Italy
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