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Adapting During the Pandemic: Changing Regulatory Processes | The COVID-19 pandemic forced unanticipated change in the way inspections, reviews and EUAs are handled by regulatory agencies and the industry. The impact on supply chain transfers, locations, registrations, and visibility is being felt across the industry. This session will focus on the regulatory guidance and direction provided by global agencies for adapting to and managing remote processes and unprecedented supply chain needs.
Session Leader(s):
V.
R. Gaines,
Branch Chief, Division of Drug Quality I,
FDA
Speaker(s):
David
Churchward,
Global Head Sterility Assurance, Cell and Gene Technologies,
Lonza Biologics
Carmelo
Rosa,
PsyD,
Director, Division of Drug Quality I,
FDA/CDER/OC/OMQ
Panelist(s):
Joey
Gouws,
PhD,
Team Lead, Inspection Services, Prequalification Team,
World Health Organization
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