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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)
Trial Master File: Telling the Study Story Through Documentation
Renee S. Heuser
AbbVie, Inc., United States
Director, Clinical Documentation Center
Industry Perspective
Bryan Christopher Souder
Merck & Co., Inc., United States
Director, TMF Head
MHRA Inspection and the Resulting TMF Process Changes
Tipsuda Kongtong, MPH
Eisai, Inc., United States
Manager, Clinical Quality Assurance