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2021 APAC Pharmaceutical Manufacturing Conference and Global Regulatory Summit

VL21CEJUN1/SES103 - Adapting During the Pandemic: Changing Regulatory Processes


Jun 18, 2021 3:00am ‐ Jun 18, 2021 4:00am


Description

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):

Speaker(s):

  • David Churchward, Deputy Unit Manager, Inspectorate Strategy and Innovation, MHRA
  • 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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