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Trial Master File: MHRA/EMA Inspections and Sponsor Audit Learnings
Session Chair(s)
Renee S. Heuser
Director, Clinical Documentation Center, AbbVie, Inc., United States
Sponsors and MHRA or EMA GCP inspectors are invited to share their experiences and learnings from the MHRA or EMA inspection of the TMF.
Learning Objective : Discuss the activities performed pre-audit or pre-inspection, the reactions of the auditor or MHRA or EMA inspector during the inspection as a result of those efforts, as well as plans for future improvements
Speaker(s)
Renee S. Heuser
Director, Clinical Documentation Center, AbbVie, Inc., United States
Trial Master File: Telling the Study Story Through Documentation
Bryan Christopher Souder
Director, TMF Head, Merck & Co., Inc., United States
Industry Perspective
Tipsuda Kongtong, MPH
Manager, Clinical Quality Assurance, Eisai, Inc., United States
MHRA Inspection and the Resulting TMF Process Changes
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