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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
參加費用：免費
主辦單位：德國EXTEDO公司，創源生物科技股份有限公司 GGA Corp.
演講者：
Dr. Silke Nolkemper 博士 (DirectorConsulting APAC)
Mr. Stefan Horneborg (Senior Business Development Manager APAC)
Dr. Pei-Li Li 李佩力 博士 (Vice President, GGA)
研討會議程 Agenda
09:00 – 9:30 Welcome and Opening Presentation
09:30 – 12:30 eCTD structure and life cycle management
I. eCTD structure (09:30 – 10:30)
· 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)
II. eCTD life cycle management (11:00 – 12:30)
· 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 Questions and answers