01486nam 2200397Ia 450 991069897500332120090619154028.0(CKB)5470000002398123(OCoLC)404100715(EXLCZ)99547000000239812320090619d2003 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierPost-approval safety data management[electronic resource] definitions and standards for expedited reporting[Rockville, Md.?] :[U.S. Dept. of Health and Human Services, Food and Drug Administration],[2003]12 digital, PDF fileTitle from PDF title page (viewed on June 19, 2009)."ICH harmonised tripartite guideline draft"."Recommended for adoption at step 2 of the ICH process on July 19, 2003 by the ICH Steering Committee"."ICH E2E ver. 3.8".Post-approval safety data management DrugsSide effectsReportingClinical pharmacologyDrugsSide effectsReporting.Clinical pharmacology.United States.Food and Drug Administration.International Conference on Harmonisation.GPOGPOBOOK9910698975003321Post-approval safety data management3530385UNINA