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Virtual

Jan 24, 2022 8:00 AM - Jan 26, 2022 5:00 PM

DIA Global Pharmacovigilance and Risk Management Strategies Conference

Global Pharmacovigilance and Risk Management Strategies Conference is now fully virtual. Join us from the comfort of your own space!

Session 3: Vaccine Safety Management

Session Chair(s)

Mariette  Boerstoel-Streefland, MD, MBA, MS

Mariette Boerstoel-Streefland, MD, MBA, MS

Senior Vice President, Worldwide Safety Officer

Bristol-Myers Squibb Company, 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
The presentations will be followed by a panel discussion where the audience is encouraged pose their questions to gain additional insights from the experts.

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

Speaker

George N. Pajovich, RPh

Pfizer Inc, United States

VP, Head of Safety Quality and Risk Management

Magnus  Nord, MD, PhD

Speaker

Magnus Nord, MD, PhD

AstraZeneca, Sweden

Vice President, Global Patient Safety BioPharma

Marianne  Hamilton Lopez, PhD, MPA

Speaker

Marianne Hamilton Lopez, PhD, MPA

Duke-Margolis Center For Health Policy, United States

Research Director, Value-Based Payment Reform

Narayan  Nair

Speaker

Narayan Nair

FDA, United States

Division Director, Division of Epidemiology, CBER

Walter  Straus, DrMed, MD, MPH, FACP

Speaker

Walter Straus, DrMed, MD, MPH, FACP

Moderna, United States

Vice President, Safety and PV

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