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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 Additionally, the EMA released its draft guidance on the TMF.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)
eTMF Compliance: Impact of ICH E6 R2 Update and EMA Draft TMF Guidance
Fran Ross
Advanced Clinical, United States
Practice Director, Trial Master File
Speaker
Joanne Malia, MS, MSc
Regeneron Pharmaceuticals, United States
Director, Development Records Management
Speaker
Ann McCabe
Daiichi Sankyo Inc, United States
Director, Process Excellence and Risk Management
Speaker
Representative Invited
FDA, United States
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