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Tuesday, November 14 • 10:00 - 13:00
Workshop B: TMF Inspection Readiness Essentials: Understanding Expectations, Document Lifecycles, and Reducing Risks

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This workshop will focus on ensuring an eTMF/TMF is inspection ready right from the beginning. An overall strategy for defining the life cycle of your documentation and knowing the expectations of the Global Regulatory agencies will help teams be prepared for inspections.
Learning Objectives: 
  • Define the full life cycle of your documentation from Site to CRO to Sponsor
  • Understand the “Story” of your trial… Start to Finish
  • Understand regulatory expectations and how to identify completeness risks and how to mitigate
  • Inspection Preparation Checklist – How to be Inspection ready from the start
Speakers
avatar for Laurel-Ann Schrader

Laurel-Ann Schrader

Director, Client Solutions, TransPerfect Life Sciences
As Director, Client Solutions at TransPerfect Life Sciences, Laurel-Ann Schrader is a resident TMF subject matter expert.Her expertise includes TMF inspection readiness, preparation, and support, best practices for clinical document processes, procedures and clinical operations, eTMF... Read More →
avatar for Avani Amin

Avani Amin

Associate Director of Client Solutions, TransPerfect Life Sciences
As Associate Director of Client Solutions at TransPerfect Life Sciences, Avani Amin joined Trial Interactive in 2018 after 10.5 years at an eTMF vendor. Initially part of the Project Management team for four years, Avani worked as an Executive Project Manager, where she was responsible... Read More →

Tuesday November 14, 2023 10:00 - 13:00 GMT
  Workshop