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Tuesday, November 3 • 12:45pm - 1:30pm
Your trial is done; now what? Quality Management in TMF Archiving

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  • Compliance with regulations (FDA part 11, EU Annex 11, GDPR, HIPAA)
  • Cloud storage vs. off-line storage and short-term vs. long-term archiving
  • Best practices for completeness assessments and ensuring inspection readiness

Moderators
avatar for Courtney Wells

Courtney Wells

Vice President, Clinical Operations, Avadel Pharmaceuticals
Courtney Wells has over 20 years' experience in drug development and clinical operations in over 35 indications. She has directly contributed to three new drug approvals and executed pivotal trials for four additional programs that led to approvals. She served as Vice President- Operations... Read More →

Speakers
avatar for Eldin Rammell

Eldin Rammell

Head of Quality Assurance, Plexglobal
Eldin is employed with Phlexglobal as Head of Quality Assurance. Prior to joining Phlexglobal in early 2019, Eldin ran a successful independent records management consultancy (Rammell Consulting Ltd) for 15 years. This followed a 17-year career as an archivist and records manager... Read More →
avatar for Mallorie Sayre

Mallorie Sayre

eTMF Manager, Clinical Operations, Moderna
I started my career with the TMF 6 years ago as an intern while earning my Master of Science in Information Studies degree. More recently I was the Manager of Clinical Documentation at AveXis where I was able to build the TMF from the ground up. There I was able to implement the Veeva... Read More →
avatar for Krista Serratore

Krista Serratore

Team Lead, TMF Operations, Alimentiv Inc.
Krista began her career in TMF over 6 years ago after graduating from the Clinical Trials Management program at Western University in London, ON. At Alimentiv Krista has overseen Trial Master Files as a CRO and vendor from start-up through to transfer & archiving. Krista now leads... Read More →


Tuesday November 3, 2020 12:45pm - 1:30pm EST