June 17 - 21, 2016Bali,Indonesia Clinical studies management & pharmacovigilance strategies Documents agenda_bali_workshop_july_17-21_v3a.pdf e6ich_gcp.pdf emea_note_guidanceclinical_evaluation_vaccines.pdf who_trs_924_clinical_evaluation_035-101.2004_1_-2.pdf dcvmn_bali_pharmacovigilance_pre-reading.pdf writing_a_clinical_development_plan.pdf clinical_development_plan18july2016_to_be_sent.pdf overview_on_vaccine_clinical_development.pdf how_to_design_a_clinical_trial_general_principles17july2016.pdf how_to_write_a_clinical_protocol.pdf from_protocol_to_csr_dcvmnjuly2016.pdf ich_gcp__dcvmn_training_july2016.pdf reportingcinicaltrialresults_dcvmn-training2016.pdf 1._introduction_dcvmn-pv.pdf 2_-_overview_of_regulatory_requirements_and_pv_systems_reformat.pdf 3_-_fundamentals_of_an_effective_pv_system_reformat.pdf 5_-_signal_identification_and_assessment_reformat.pdf 6._psurs_dcvmn-pv.pdf 7._rmp_dcvmn-vp.pdf