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Tuesday, March 10 • 4:00pm - 4:45pm
The Role of Preclinical and Clinical Quality in Business Development Opportunities

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  • Determine whether preclinical and clinical work for approved/pending products has been conducted within quality standards
  • Evaluate data utilized for Investigational New Drug (IND) or other HA applications
  • Review data storage and transfer practices, as well as pivotal tests for data traceability, integrity, and potential bias
  • Determine GLP/GCP regulation compliance, HA history
  • Evaluate the target company SOPs, processes, quality culture and assess vendor selection and management

If you are interested in leading this session, please contact Michael Williams at mwilliams@exlevents.com.

Tuesday March 10, 2020 4:00pm - 4:45pm