戻る Agenda
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)
ICH E6 Addendum – Overview and Progress
Gabriele Schwarz, MPHARM
Germany
EC ICH E6(R3) Expert Working Group Member
How do Auditors Adapt to Risk-Based Monitoring?
Kristel Van De Voorde, MPHARM
GSK, Belgium
Senior Director, Pharmacovigilance QA