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Safety assessment in Clinical Trials and Beyond. Yuliya Yasinskaya, MDNovember 8, 2011Medical OfficerDivision of Anti-infective ProductsCenter for Drug Evaluation and Research. . Outline. IntroductionSources of safety informationIs your patient right for the trial?Safety monitoring/ AE asce
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1. Cosponsored by FDA’s Office of Critical Path Programs (OCPP) and The Clinical Trials Transformation Initiative (CTTI)