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Thursday, June 22 • 10:45am - 12:00pm
#409: Trial Master File: MHRA/EMA Inspections and Sponsor Audit Learnings

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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


Renee S. Heuser


Trial Master File: Telling the Study Story Through Documentation
Renee S. Heuser

Industry Perspective
Bryan Christopher Souder

MHRA Inspection and the Resulting TMF Process Changes
Tipsuda Kongtong, MPH

avatar for Renee Heuser

Renee Heuser

Director, Clinical Documentation Center, AbbVie, Inc.
Renee started with Abbott/AbbVie in Oct 1990; her 26 years of clinical experience spans early to late drug development in Clinical Operations and Project Mgmt roles across several Therapeutic Areas. She has received the company's President's award many times for her contributions... Read More →

Tipsuda Kongtong

Manager, Clinical Quality Assurance, Eisai, Inc.
Tipsuda joined Eisai in 2012 and has held positions in clinical operations and clinical quality assurance. In her current role, she is responsible for GCP audits and leading inspection readiness activities. Tipsuda has 13 years of clinical research experience in neurology, oncology... Read More →

Bryan Souder

Senior Director, TMF Head, Merck & Co., Inc. Kenilworth, NJ USA
Bryan Souder is an Associate Director at Merck & Co., Inc. He has a BS from Radford University, a Six Sigma Greenbelt, and 22 years of clinical trial research experience. His current focus is being TMF Head. Prior to leading the department Bryan was the eTMF “Global Implementation... Read More →

Thursday June 22, 2017 10:45am - 12:00pm CDT
S402ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  09: TranslSci-Preclin-Clin-ProdDev, Session