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ICH E6- GCP Addendum: Risk Proportionate Approaches to Trial Design and Conduct
Session Chair(s)
Fergus Sweeney, PhD
Head of Clinical Studies and Manufacturing Task Force, European Medicines Agency, Netherlands
The ICH E6 Good Clinical Practice addendum sets out to modernise GCP, setting out a clear risk-based approach to quality management and monitoring and embracing new technologies.
Speaker(s)
Gabriele Schwarz, MPharm
EC ICH E6(R3) Expert Working Group Member, Germany
ICH E6 Addendum – Overview and Progress
Kristel Van De Voorde, MPharm
Senior Director, Pharmacovigilance QA, GSK, Belgium
How do Auditors Adapt to Risk-Based Monitoring?
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