法搜网--中国法律信息搜索网
法律信息 | 法律新闻 | 案例 | 精品文章 | 刑事法律 | 民事法律 | 经济法律 | 行政法律 | 诉讼法律 | 合  同 | 案例精选 | 法律文书 | 合同范本 | 法律常识 | 司考题库 | 
法律图书 | 诉讼指南 | 常用法规 | 法律实务 | 法律释义 | 法律问答 | 法规解读 | 裁判文书 | 宪法类 | 民商法类 | 行政法类 | 经济法类 | 刑法类 | 社会法类 | 案例趋势 |     
国家食品药品监督管理局药品安全监管司关于举办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的通知

  □ 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

单位

 

姓名

 

性别

 

手机

 

部门

 

职务

 

姓名

 

性别

 

手机

 

部门

 

职务

 



第 [1] [2] [3] [4] [5] [6] [7] [8] 页 共[9]页
上面法规内容为部分内容,如果要查看全文请点击此处:查看全文
【发表评论】 【互动社区】
 
相关文章




法律信息 | 法律新闻 | 案例 | 精品文章 | 刑事法律 | 民事法律 | 经济法律 | 行政法律 | 诉讼法律 | 合同 | 案例精选 | 法律文书 | 合同范本 | 法律常识 | 
法律图书 | 诉讼指南 | 常用法规 | 法律实务 | 法律释义 | 法律问答 | 法规解读 | 裁判文书 | 宪法类 | 民商法类 | 行政法类 | 经济法类 | 刑法类 | 社会法类 |