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eTMF CHALLENGES
Session Chair(s)
Karen Roy, MPharm
Chief Strategy Officer
Phlexglobal, United Kingdom
Learning Objective : Compare the pros/cons of standardisation from a CRO perspective working with many sponsors. Adapt your own Index to the TMF Reference Model or integrate with your CROs. Manage conflicts within the Indices and best approach.
Speaker(s)
eTMF Standardisation from a CRO Perspective
Jamie Toth, MS
Beigene, United States
Global Head, TMF Management & Records
“The Road to Hell is Paved with Good Intentions” and eTMF Implementations…Anything in common?
Lisa Mulcahy
Mulcahy Consulting, LLC, United States
Owner, Principal Consultant
How to Prepare for an eTMF Inspection
Wendy Trimboli
Eisai Product Creation Systems (EPCS), United States
Associate Director, TMF Process Management & Quality Control, GRA
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