聚焦2019藥品電子送件法規新動向 立足全球生技醫藥產業市場 研討會

09:00 - 09:15

Welcome / Agenda

09:15 - 10:15

Session 1: Global regulatory update

• Status of e-Submissions in the regions
  (EU, US FDA, ASEAN, Jordan, Australia …) 

10:15 - 10: 30

Coffee Break

10:30 - 11:15

Session 2: From a single document to the eCTD submission

• How to setup electronic submission in your company?
• What are the tools you need?
• How do you find an appropriate software vendor?

11:15 - 12:30

Session 3: EU eCTD submissions

• Regulatory Information on
  • Procedure Types (NP, MRP, DCP, CP)
  • Submission Types (e.g. MAA, Variations)
  • Active Substance Master File (ASMF)

• EXTEDO eCTDmanager Case Study
  “From NP to MRP – how to publish an eCTD efficiently”

12:30 - 13:30

Lunch

13:30 - 15:00

Session 4: US FDA Submissions

• Regulatory Informatio on (NDA, ANDA and IND)

• US FDA specific Requirements
  • Structured Product Labeling (SPL)
  • Study Tagging Files (STF)
• EXTEDO eCTDmanager Case Study
  “The new“Grouped Submissions” feature”

15:00 - 15:15

Coffee Break

15:15 - 16:00

Session 5:

• Best practice of electronic submissions
• Common errors in electronic submissions

16:00 - 16:30

Session 6: eCTD 4.0

• Objectives and Benefits
• Current status
• Roadmap

16:30 

Closing