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Global Trends in Regulatory Reliance: Will the COVID-19 Experience Accelerate Implementation?
Session Chair(s)
Jayne Ware, MPH, MSc
Senior Director, Global Regulatory Policy, Merck Sharp & Dohme LLC, United States
Explore growing trend of regulatory reliance, providing a global environmental scan of regulatory definitions and application of reliance policies. Feature perspectives on benefits and challenges to industry highlighting COVID-19 experiences.
Learning Objective : Discuss the concepts of regulatory reliance and global trends in applying reliance; Explore the benefits and challenges to industry as a result of these trends; Identify from shared insights on reliance approaches related to licensing of COVID vaccines and therapeutics.
Speaker(s)
An Industry Perspective on Regulatory Reliance Trends
Rebecca Lumsden, PhD
Head of Regulatory Science & Policy EU/AMEE, Sanofi, United Kingdom
Trends in Regulatory Reliance
Lawrence Eugene Liberti, RAC
Director, D.K. Kim International Center for Regulatory Science, The Kim Center/ USC DRQS, United States
Examples of Reliance Activities Implemented by Regulators and Their Perspectives Based on The International Pharmaceutical Regulators Programme (IPRP) Studies
Nobumasa Nakashima
Professor / Director, Department of Medicinal Regulatory Science, Graduate Schoo, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Japan
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