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A Paradigm Shift in Global Regulatory Reviews: Has the New Normal Arrived?
Session Chair(s)
Helen Bayes Hartman, PhD
Director, Global Regulatory Sciences
Pfizer Inc, United States
Global expert presentations and in-depth panel discussion on the regulatory agilities, regulatory reliance, platform approaches, and other regulatory innovations that are pivotal during public health emergencies and necessary for future pandemic preparedness.
Learning Objective : Discuss regulatory agilities, reliance and platform approaches which significantly decreased review times internationally for COVID vaccines. Discuss additional CEPI case studies that highlight regulatory innovations to address future public health emergencies, and the inherent complexities of sustaining these innovations from a health authority perspective.
Speaker(s)
Regulatory Reliance and Platform Approaches: Has the New Normal Arrived??
Donna Boyce, MS, RAC
Pfizer Inc, United States
Head and Senior Vice President of Global Regulatory Sciences
Preparedness: Challenging the Traditional Regulatory Paradigms to Address Public Health Emergencies
Debra Yeskey
CEPI, United States
Head of Regulatory Policy and Intelligence
FDA Update
David C. Kaslow, MD
FDA, United States
Director, Vaccines Research and Review (OVRR), CBER
Moderator
Khushboo Sharma, MBA
Accumulus Synergy, United States
Chief Regulatory Innovation Officer
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