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Tuesday, November 3 • 9:10am - 9:40am
Key Document Reviews- A Risk Based Approach to TMF QC

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  • Understand the meaning of TMF Oversight
  • Leverage your eTMF system reports to assess “Key” Documents
  • Use identified gaps to understand the health of your TMF as managed by Sponsor or CRO

avatar for Anusha Rameshbabu

Anusha Rameshbabu

Trial Master File (TMF) Process Specialist, Alexion Pharmaceuticals, Inc.
Anusha Rameshbabu is a TMF Process Specialist at Alexion in Boston, MA. Her role involves collaborating with TMF stakeholders throughout her organization to identify and address process gaps and oversee TMF activities across several clinical studies. As part of this role she has developed... Read More →
avatar for Stephanie Viscomi

Stephanie Viscomi

Associate Director, TMF Operations, Alexion Pharmaceuticals, Inc.
Innovation-minded and results-driven Clinical Research Document Management professional. Stephanie’s experience is in all stages of biopharmaceutical and medical device development ,early phase through post-approval and across multiple therapeutic areas. Broad-ranging skills in... Read More →

Tuesday November 3, 2020 9:10am - 9:40am EST