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Session Chair(s)
Fergus Sweeney, PHD
Head of Clinical Studies and Manufacturing Task Force
European Medicines Agency, Netherlands
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