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ICH Info Day Part 2
Session Chair(s)
Agnès Saint-Raymond, DrMed
Head of Division International Affairs
European Medicines Agency, Netherlands
Part 2 of the ICH Info Day looks at the Efficacy suite of guidelines, in particular the renovation of E6 and E8 GCP guidelines, E17 Multi-regional clinical trials and E9 estimands.
Speaker(s)
E8 and E6 Renovation Plan of Action - Putting GCP in the Context of the ‘E Family’
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs
E17 Multi-Regional Clinical Trials
Toshiyoshi Tominaga, PHD
SunFlare Co., Ltd, Japan
Life Science Department, Advisor
E9(R1) Estimands
Robert Hemmings, MSC
Critical Path Institute, Netherlands