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Control Strategy Global Harmonization Webinar - 20 May
April 8, 2021
IQ Webinar: Control Strategy Global Harmonization
Presenters: KeAndra Robinson (Biogen), Greg Rullo (AstraZeneca) and Tim Watson (Pfizer)
Sponsored by the IQ Control Strategy Global Harmonization Working Group
The purpose of this presentation is to share data collected by the IQ Consortium - Control Strategy Global Harmonization Working Group that highlight instances where different regulatory agencies diverge from the ICH guidance in their evaluation of the CTD submitted by industry (same scientific data). The data illustrates where this divergence led to modifications to control strategies, leading to different CS globally, for a product intended for global markets.