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Session 7 Track 3: Understanding ICH E6 R2 and the Impact to Clinical Trial Documentation and the Trial Master File
Session Chair(s)
Joanne Malia, MS, MSC
Director, Development Records Management, Regeneron Pharmaceuticals, United States
ICH E6 R2 was released in November 2016 and has outlined new expectations for all stakeholders of clinical trials. Additionally, the EMA released its draft guidance on the TMF. This session will discuss the resulting expectations impacting clinical trial documentation and the Trial Master File (TMF). The impact and response from different stakeholders such as vendors, sponsors, and regulators will be presented and discussed.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand new and coming expectations for TMF management due to ICH E6 R2 and EMA draft TMF guidance
- Distinguish draft EMA TMF Guidance boundaries from inspection requirements
- Recognize and take away practical strategies for eTMF compliance to regulations
Speaker(s)
Fran Ross
Practice Director, Trial Master File, Advanced Clinical, United States
eTMF Compliance: Impact of ICH E6 R2 Update and EMA Draft TMF Guidance
Joanne Malia, MS, MSC
Director, Development Records Management, Regeneron Pharmaceuticals, United States
Speaker
Ann McCabe
Director, Process Excellence and Risk Management, Daiichi Sankyo Inc, United States
Speaker
Representative Invited
Senior Medical Officer, Office of Scientific Investigations, OC, CDER, FDA, United States
Speaker