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Thursday, April 8 • 8:45am - 9:45am
PANEL DISCUSSION: Global Inspection Gossip

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Share Recent Experiences with Inspections and Other Engagement with Various Regulatory Authorities 
  • Discuss recent inspection experiences during the pandemic
    • Share communication with regulatory agencies during the pandemic
    • Were you part of a hybrid or remote inspection?  What did that look like?
  • Understand experiences with direct access to systems and the associated challenges
  • Receive an update on China GCP and the associated challenges

avatar for Mike Sobczyk

Mike Sobczyk

Executive Director, R&D Quality and Compliance, Gilead Sciences
Mike Sobczyk has a Bachelor of Science degree in biology from the University of Nebraska at Omaha and a Master of Health Sciences from George Washington University. Mike is currently working at Gilead Sciences Inc. as the Executive Director of R&D Quality and Compliance. Over the... Read More →
avatar for David M. Potter

David M. Potter

Clinical Inspection Readiness & Risk Management Lead, KYOWA KIRIN
David Potter has been in the Pharma Industry for the past 28 years.  He is currently and has been at Kyowa Kirin USA Holdings, Inc. and has for the past 13 years.  He served in the Biometrics Group as the head of Data Management and Programming while supporting the growth and development... Read More →
avatar for David Fryrear

David Fryrear

Executive Vice President, Head of Quality Assurance, ASTELLAS
David Fryrear, M.S., is Executive Vice President and Head of the Quality Assurance for Astellas and has responsibility for providing the global vision, leadership and strategic direction for Quality Assurance, from the earliest stages of research, through clinical development, and... Read More →
avatar for Michele Weitz

Michele Weitz

Senior Director, Clinical Operations Standards and Innovation, CLOVIS ONCOLOGY
A pragmatist on a mission to make clinical trial regulatory requirements meaningful and accessible to a tough crowd, Michele has worked as both an employee and consultant at pharmaceutical companies of all sizes—from 23 to 111,000 employees, in many therapeutic areas and around... Read More →

Thursday April 8, 2021 8:45am - 9:45am EDT