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Wednesday, November 4 • 11:20am - 11:50am
TMF in the Virtual Inspection Reality

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  • Implications of accessing your TMF in a virtual inspection/audit landscape
  • Summary of a sponsor’s experience (and lessons learned) in recent virtual GCP inspections (Health Canada, MHRA)

avatar for Liz Farrell

Liz Farrell

Associate Director, Global Safety and Regulatory Sciences Records Management, Trial Master File, Biogen
Liz is an Associate Director within Records Management-TMF at Biogen and currently oversees TMF process and quality for phase I-IV trials to ensure ongoing compliance across the organization. During Liz’s 7+ years at Biogen, she has been involved in numerous regulatory inspections... Read More →

Wednesday November 4, 2020 11:20am - 11:50am EST