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ELECTRONIC TRIAL MASTER FILE (eTMF) INSPECTION
Session Chair(s)
Bram Van Den Brink
IT Director Operations
Abbott Healtcare Products B.V., Netherlands
Learning Objective : -Review the recent publications from the MHRA and EMA on the topic of direct access to e-content -Utilize the information presented against their own established company processes to access need for revision
Speaker(s)
Considerations for Providing DIRECT Access to the eTMF (and other content repositories) for Health Authority Inspections
Lisa Mulcahy
Mulcahy Consulting, LLC, United States
Owner, Principal Consultant
Managing an eTMF for Inspection Readiness
Martin David Thorley
Pfizer Ltd, United Kingdom
Associate Director - Senior Information Manager
What to Expect During an MHRA eTMF Inspection – experience, challenges and best practices based on a recent inspection
Wendy Trimboli
Eisai Product Creation Systems (EPCS), United States
Associate Director, TMF Process Management & Quality Control, GRA
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