COVID-19 360°: Embedding Global Best Practices in Routine Regulatory Action and Preparing for the Next Pandemic

11:00 AM - 12:00 PM (PDT), Wednesday, June 15, 2022

The urgency of the COVID-19 pandemic has accelerated the development, trial, and use of innovative regulatory tools and in many ways changed how global regulators work and collaborate with each other and with many different stakeholders. While we cannot expect regulators to continue the frenetic pace seen in the pandemic, this “natural experiment” has surfaced regulatory agilities that agencies could retain, in some cases, beyond the pandemic to strengthen routine regulatory practice, prepare for the next pandemic, and build a more coordinated global regulatory system. Commentary has been building on ‘lessons learned’ from COVID-19, but we also need to consider these flexibilities from a wide range of perspectives – the 360° review. Critically, we need to understand the impact, both positive and negative, these agilities have had on various stakeholders. 

Moderator
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Director, Global Regulatory Policy
Merck
Speakers
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Associate Principal, Vaccine Policy and Market Access
Avalere Health
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MD
European Medicines Agency (EMA)
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CDER
FDA
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Senior Director of Policy
Everylife Foundation For Rare Diseases