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3rd Clinical Quality Oversight
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Wednesday, May 22 • 11:00am - 11:45am
DON’T INSPECT IN QUALITY, BUILD IT IN

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Understand FDA’s Push to Build Quality into the Clinical Trial Process through Proactive Compliance, Instead of Leveraging Inspections to Trigger Quality Measures 
  • Understand what it means to build in quality
  • Examine recent  inspection finding trends and how they relate to quality by design
  • Discuss proactive actions organizations can take to showcase risk management practices, to expedite or even eliminate the need for an inspection
  • Extended Q&A so bring your burning questions
Speakers
avatar for Sharon Reinhard

Sharon Reinhard

Clinical Quality Expert, Independent Consultant
Experienced pharmaceutical executive with 25 years of industry experience, including roots in academia. Most recently Head of Commercial and R&D Quality at AVEO Oncology.  Prior to that, Vice President/ Head of Quality at AVROBIO, a gene therapy company focused on lysosomal storage... Read More →
avatar for Priya Chaturvedi, Ph.D.

Priya Chaturvedi, Ph.D.

Vice President, Head of Global Clinical Quality, EISAI, INC.
Priya Chaturvedi is Vice President, Head of Global Clinical Quality at Eisai inc. She has responsibility for Global Clinical Quality Assurance (CQA), Global Clinical Quality Management and Global Process and Standards. She joined Eisai in 2019. Prior to that, she was Executive Director... Read More →


Wednesday May 22, 2024 11:00am - 11:45am EDT
  Included in VIRTUAL Experience