eCTD電子查驗送件最佳規範實例與簡介 Introduction and Best Practices about Electronic Submissions in eCTD Format (with Hands-On Session)

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時間:7月5日 星期三 9:00~17:00
地點:六福萬怡酒店9樓 風光廳 
地址:台北市南港區忠孝東路七段359號 (交通資訊請見附頁)
主辦單位:德國EXTEDO公司,創源生物科技股份有限公司 GGA Corp.
Dr. Silke Nolkemper博士 (Director Consulting APAC, EXTEDO GmbH)
Mr. Stefan Horneborg (Senior Business Development Manager APAC, EXTEDO GmbH)
Dr. Pei-Li Li 李佩力 博士 (Vice President, GGA Corp.)
研討會議程 Agenda
09:00 – 9:30         Welcome and Opening Presentation
09:30 – 10:30      eCTD Structure

  • CTD vs. eCTD: differences between paper dossiers and electronic dossiers
  • General structure of an eCTD
  • Files and folders
  • Meta data
  • Bookmarks and Hyperlinks
  • XML-backbone, Envelope

10:30 – 11:00      中場休息 (茶歇)
11:00 – 12:30      eCTD Life Cycle Management

  • Lifecycle Attributes Experience in EU in e-CTD: how can several strengths and dosage forms be handled in one eCTD dossier (handling of specific sections)
  • Submission Lifecycle, e.g. Variations, line Extensions
  • Document Lifecycle (add/replace/delete/append documents)

12:30 – 13:30      午餐時間
13:30 – 15:00      eCTD Regional Differences

  • Best Practice
  • EU M1 and ASMF as special structure
  • US M1 and US DMF
  • Document requirements for US
  • ESG
  • Publishing Services

15:00 – 15:30      中場休息 (茶歇)
15:30 – 17:00      Hands-On to EXTEDO eCTDmanager or Live Demo
17:00                   Questions and Answers

Registration and Details 

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