Pharmacovigilance Strategies Workshop

This session looks to explore multiple aspects of regulatory changes that impact Patient Safety and Pharmacovigilance activities from different regions around the world. Multiple PV topics will be addressed; starting with an FDA perspective on combination product regulations followed by an update on the EMA GVP for RMM; the next topic will cover ICH E2D activities and specifically an update on the discussions that are taking place; the latest on EV monitoring for signals and the industry experience; an update on the Clinical Trial Regulation that is nearing its implementation; and finally, an update on the ICH E2B activities in an international context. A lot of work is taking place in the emerging markets to promote ICHE2B standards, so the final topic in this session will be truly international.