Back to Agenda
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)
George N. Pajovich, RPH
VP, Head of Safety Quality and Risk Management, Pfizer Inc, United States
Speaker
Magnus Nord, MD, PHD
Vice President, Global Patient Safety BioPharma, AstraZeneca, Sweden
Speaker
Marianne Hamilton Lopez, PHD, MPA
Research Director, Value-Based Payment Reform, Duke-Margolis Center For Health Policy, United States
Speaker
Narayan Nair, MD
Associate Director Regulatory Affairs, Office of Biostatistics and Pharmacovigil, FDA, United States
Speaker
Walter Straus, DrMed, MD, MPH, FACP
Vice President, Safety and PV, Moderna, United States
Speaker
Have an account?