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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
Sanofi, United Kingdom
Head of Regulatory Science & Policy EU/AMEE
Trends in Regulatory Reliance
Lawrence Liberti, PhD, RAC
The Kim Center/ USC DRQS, United States
Director, D.K. Kim International Center for for Regulatory Science
Examples of Reliance Activities Implemented by Regulators and Their Perspectives Based on The International Pharmaceutical Regulators Programme (IPRP) Studies
Nobumasa Nakashima
Cabinet Office, Japan
Health Policy Director, National Healthcare Policy Secretariat
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