Clinical studies management & pharmacovigilance strategies (Bali, Indonesia)

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

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