□ Other Specify： __________________________________________
Q13： Are the clinical trials sponsored by your company registered in a clinical trial registry?
□ No
□ Yes， sometimes
□ Yes， always
□ Not applicable
Q14： When your company performs clinical trials， who performs the immunogenicity
test
□ own laboratory
□ specialized laboratories contracted for the purpose
□ depending on type of
test in house or outsourced
□ not applicable
VII. Post-Marketing surveillance
Q1： Does your company have a Department of Pharmacovigilance?
□ No
□ Yes
Q2： Does the Pharmacovigilance Department of your company employ at least? （more than one answer allowed）
□ one physician （medical doctor）
□ one pharmacist
□ not applicable
Q3： How does your company collect information on adverse events following immunization （AEFIs） observed with its vaccines after they are registered/licensed/marketed? （more than one answer allowed）
□ spontaneous reports by physicians
□ spontaneous reports by other health professionals
□ active surveillance
□ phase IV clinical trials
□ none
□ not applicable
Q4： Does your company prepare periodic safety update reports （PSURs） of its products?
□ No
□ Yes
Q5： Is the presentation of a pharmacovigilance plan currently a requirement for the registration/licensure/marketing authorization of vaccines in China?
□ No
□ Yes
附件3：
世界卫生组织疫苗预认证申报程序培训班暨
疫苗生产企业座谈会参会回执
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