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Regulatory Affairs Lessons Learned in the Crucible of COVID-19: What Works and What Could Work
Session Chair(s)
Max Wegner, PHARMD, RPH
Head Regulatory Affairs
Bayer AG, Germany
The COVID-19 pandemic challenged regulatory ways of working, introducing flexibilities and adaptations that may continue well beyond the pandemic period. This session will discuss lessons learned and case examples describing what works and what could work.
Learning Objective : • Describe Lessons Learned in Regulatory Affairs during the pandemic period of COVID-19, including specific case examples • Discuss news ways of working internally across project teams, and interactions with regulator agencies in a time of public health emergency • Elaborate new opportunities for what could work in a post-pandemic period based on lessons learned
Speaker(s)
Title to be Announced
Claus Bolte, DrMed, MBA
Swissmedic, Switzerland
Head of Authorisation
Title to be Announced
David B. Jefferys, MD, FRCPC
EISA EUROPE LTD, United Kingdom
Senior Vice President