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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)
Donna Boyce, MS, RAC
Senior Vice President & Head, Global Regulatory Sciences, Pfizer, United States
Regulatory Reliance and Platform Approaches: Has the New Normal Arrived??
Debra Yeskey
Head of Regulatory Policy and Intelligence, CEPI, United States
Preparedness: Challenging the Traditional Regulatory Paradigms to Address Public Health Emergencies
David C. Kaslow, MD
Director, Vaccines Research and Review (OVRR), CBER, FDA, United States
FDA Update
Khushboo Sharma, MBA
Chief Executive Officer, Accumulus Synergy, United States
Moderator
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