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Session 3: Vaccine Safety Management
Session Chair(s)
Mariette Boerstoel-Streefland, MD, MBA, MS
Senior Vice President, Patient Safety Officer
Bristol Myers Squibb, United States
Hear from relevant representatives about challenges and learnings of safety management for the unprecendented situation with the vast COVID-19 vaccine rollout in this panel discussion.
Representatives from the primary vaccine producers will provide a short introduction on their experience, covering various angles:
- Pharmacovigilance Operations –handling large amounts of data, safety database management, case entry
- Signal detection and risk communication – ‘needle in a haystack’
- Regulatory interactions
Learning Objective : - Understand complexities in management of sudden peaks and unprecedented volume of adverse events, discover solutions to deal with sudden peaks in volumes
- Hear about experiences with safety management and surveillance with early access and limited safety data at market introduction, with heightened focus on emerging safety issues
- Gain perspectives on regulatory interactions with the accelerated COVID-19 vaccine roll out
Speaker(s)
Speaker
George N. Pajovich, RPh
Pfizer Inc, United States
VP, Head of Safety Quality and Risk Management
Speaker
Magnus Nord, MD, PhD
AstraZeneca, Sweden
Vice President, Global Patient Safety BioPharma
Speaker
Marianne Hamilton Lopez, PhD, MPA
Duke-Margolis Center For Health Policy, United States
Research Director, Value-Based Payment Reform
Speaker
Narayan Nair, MD
FDA, United States
Associate Director Regulatory Affairs, Office of Biostatistics and Pharmacovigil
Speaker
Walter Straus, DrMed, MD, MPH, FACP
Moderna, United States
Vice President, Safety and PV