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Tuesday, March 21 • 4:15pm - 4:45pm
Understand Your eTMF Metrics and Introduce a Risk-based Approach to eTMF Management

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To ensure a healthy and efficient eTMF, a risk-based approach to eTMF management allows organizations to decrease time and effort on eTMF management while increasing focus on critical content.
This session will discuss essential components of a successful metrics program, provide an overview of an advanced eTMF metrics program including lessons learned, and deep dive into risk-based eTMF management frameworks.

Speakers
avatar for Candace Rieder

Candace Rieder

Director, Clinical Records, Gilead
Candace Rieder is Director of Clinical Records at Gilead Sciences, responsible for TMF strategy, oversight, and progressing TMF compliance across Gilead. Candace is currently Business Process Owner for TMF management processes and eTMF at Gilead Sciences and Kite Pharma.Candace has... Read More →
avatar for Franciska Darmer

Franciska Darmer

Director, Clinical Life Science Advisory & Consulting, NNIT
With more than 25 years of experience within the life science industry, Franciska has worked for numerous Life Science organizations and technology vendors, supporting customers on their strategic digitalization journeys across clinical operations including focus on eTMF Transformation... Read More →


Tuesday March 21, 2023 4:15pm - 4:45pm EDT